FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility

The United States Food and Drug Administration (FDA) UU has released a highly drafted form 483, sent last month to Glenmark Pharmaceuticals manufacturing facilities in Solan, India on Tuesday.

One of the seven observations on Form 483, first announced by the company on Nov. 28, noted that FDA inspectors found at least 13 quality documents "crushed into the teeth and internal moving parts of the crusher ". "

The FDA stated that the quality documents were not in the logbook as required by one of the site's standard operating procedures.

Further comments focused on the fact that the site did not thoroughly investigate unexplained lot spreads and failures, deficiencies in complaint files and lack of written procedures for production and process controls.

In one case, Form 483 indicates that the company attributed a batch error to the sample preparation error "by providing photographs of sample vials indicating alleged preparations of abnormal samples". The photographs included in the survey did not include stamps. of date ... The authenticity of the supporting photographs could not be verified by the investigators of the FDA. "

Glenmark stated that the manufacturing unit that received Form 483 contributes about 10% of the company's sales to the United States. UU And that the company "is in the process of providing a complete response to the observations."

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

On Monday, the Rules Committee of the House of Representatives will adopt a provision that would expand the ability of the US Department of Defense to urgently approve medical products, according to the US Food and Drug Administration Commissioner. United (FDA) Scott Gottlieb for the provision to be rejected

According to the committee conference report on the National Defense Authorization Act for fiscal year 2018, the House will add the Senate amendment to authorize the Secretary of Defense to approve the emergency use of medical products outside of the US. UU., Expanding the capacity of the Department of Defense to approve these products.

"Participants agree that the traditional routes for the approval and authorization of the Food and Drug Administration of critical medical products for the care of combat victims are too slow to allow a rapid insertion and use of these products on the battlefield "said the report.

Speakers in the House noted "even higher survival rates due to severe combat injuries and injuries suffered by service members" as a reason to add the provision, although they said they expect the FDA to be consulted when evaluating medical products for the care of combat victims and use this new authority strictly for the approval of medical products for injuries and injuries on the battlefield. "

The FDA and the Department of Defense are already working together on the emergency use authorizations (EUA), including the DoD presentations, in accordance with the FDA's guidance on the use of said US as of January. For example, in 2014, the FDA issued an EUA to authorize the use of the EZ1 Real-Time DZ-PCR Assay of the Department of Defense for the detection of Ebola Zaire virus during the outbreak in West Africa.

The decision to add the provision to the House bill followed Gottlieb's comments earlier this week, which is rare for an agency that often says it will not comment on pending legislation, which must maintain such approvals within the scope of the FDA. The former commissioners of the FDA have also had problems with the provision.

And the move to carry it out in the House committee on Monday may not indicate that the change is final. Senator Patty Murray (D-WA) told Axios that an agreement had been reached with Senator Lamar Alexander (R-TN) to maintain US reviews under the FDA, but the DoD could pressure the FDA to expedite certain product reviews.

Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling

The total number of transactions in which brand-name drug companies pay to delay the entry of generic competitors continues to decline, and only 5 of 170 final 2015 settlements included generic compensation and entry restriction generic, the Federal Trade Commission (FTC) said in a report released on Wednesday.

Fiscal 2015 is the second full year of filings since the Supreme Court ruled FTC v. Canada. Actavis, Inc. in June 2013, when it concluded that a drug company's transfer to a generic competitor to settle a patent dispute could violate antitrust laws. The decline in fiscal 2015 follows a similar decline revealed in a report from the FTC last year.

"In accordance with the 2014 fiscal year, the number of settlements that can lead to late payment continues to decline significantly as a result of the Actavis decision, even though the total number of settlements filed with the FTC has increased," the report says.

During the 2015 financial year, the total number of definitive settlements was 170, compared to 140 in 2012, 145 in 2013 and 160 in 2014. However, the number of potential deferred payment agreements fell to 14 in 2015, from a high of 40 late payment settlements for fiscal year 2012.

Of these 14, 10 included compensation in the form of a cash payment only for litigation costs (one of which included a cash payment of more than $ 7 million), while the other four included a promise of non-commercialization. an authorized generic in competition with the generic manufacturer for a period.

Ten additional definitive regulations are classified by the FTC as containing "possible compensation" because it is not clear whether certain provisions in the agreements are equivalent to what should be considered compensation for the generic patent applicant.

"For example, an agreement containing a declining royalty structure, in which the generic's obligation to pay royalties is reduced or eliminated if a brand launches an authorized generic product, can have the same effect as an explicit commitment without MGAs. ", says the report. .

In addition, 126 of the 170 final regulations limited the ability of the generic manufacturer to market its product, but did not include explicit or possible compensation ...

UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

According to a report published Monday, trade associations, manufacturers, universities and researchers gave their opinion on the draft strategy of the UK Medicines and Health Products Regulatory Agency (MHRA) for standards development. pharmacological.

In general, the MHRA argues that the value of standardization has been confirmed and that standards could add value, including providing guidance and ensuring consistency of product characterization and quality control, ensuring the performance of standards. analytical methods and facilitate the development of bioanalytical methods.

context

In January, the MHRA asked for comment on its strategy as more organic products entered the market and the regulator sought to become "a precursor and precursor of innovative approaches to standardizing biological drugs."

MHRA has established a five-year strategy for biological pharmacological standards, with a first step in comparing its current approach to the development of biological monographs with alternative procedures. The regulator is also planning to identify gaps and weaknesses in its current portfolio of standards and strengthen its understanding of these needs, including strengthening industry linkages and knowledge of how manufacturers control quality. products.

These and other activities will require the MHRA and its regulatory units, the National Institute of Biological Standards and Control and the British Pharmacopoeia, to pool their resources.

Earlier this year, a group of government agencies was established to help implement the strategy, including experts from the MHRA, UK Innovation Office, British Pharmacopoeia and NIBSC.

Consultation Comments

MHRA says: "It was clear that many stakeholders felt that both the type and function of" standards "were essential to ensure they were fit for purpose."

For example, for biotechnologically produced proteins, comments indicated that standards "should not be unnecessarily restrictive and allow the development of new products and technologies over time", while recognizing the specific nature of these concepts standardization products.

For Advanced Therapy Medicine (ATMP), commentators stated, "Due to the emerging nature and complexity of this product category, it is important that the standards developed are not unnecessarily restrictive and do not impede key areas in which standards could add value would be the development of a common understanding and the coherence of testing methodologies. "

The MHRA also noted that for ATMPs, "there was a strong preference for non-mandatory guidance, including standards for specific analytical technologies and techniques supported, as appropriate, by physical standards.

A number of interest groups also suggested exploring two new concepts for complex biological drugs, such as monoclonal antibodies, although MHRA notes that they were previously recommended in an International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the European Generics Association (EGA) 2014.

Setting the standards for raw materials has also been "widely recommended," MHRA said. "Control of raw materials was considered important because its properties could influence the critical quality attributes of bulk biological substances."

Looking ahead, the MHRA reports that it will hold a symposium in 2018 on the progress of its work on pharmacopoeia standards and that annual updates will be provided through symposia or online events.

EMA Adds New Excipients to Labeling Requirements

The European Medicines Agency (EMA) updated on Monday its annex to the European Commission guidelines on the labeling of excipients, adding five new excipients and extending the safety warnings required for 10 others.

Excipients are defined as any part of a drug other than the active pharmaceutical ingredient. Most excipients are considered inactive, although some may cause reactions under certain circumstances. For example, lactose is commonly used as a filler in tablets, but may cause reactions in patients lactose intolerant.

This document lists excipients known to have a recognized action or effect and is to be declared on the label and package leaflet, is being updated for the first time since its publication in 2003.

The update also comes at a time when the European Commission is considering revising its guidelines on the labeling of excipients following a public consultation that ended in May.

The five newly listed excipients include boric acid, cyclodextrins, phosphate buffers, sodium laurilsulfate and perfumes containing allergens. The appendix includes an appendix listing 26 specific perfume allergens such as cinnamon and oak moss that must be included in the labeling.

Regarding new safety information, the EMA indicates that the revised Annex "pays particular attention to ... the safety of these excipients when used in children or pregnant women". For example, the appendix contains new safety information that should be included in the package leaflet for benzyl alcohol-containing medicines that advise pregnant or lactating women to consult with their doctor or pharmacist before taking the drug.

The EMA indicates that the revised Annex enters into force immediately for all centrally and nationally authorized medicinal products and that current marketing authorization holders are required to update the labeling of their products at the first opportunity. For products that are not subject to regulation, the EMA indicates that developers are required to submit a Type IB variant detailing labeling changes over the next three years

ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

The International Council of Harmonization (CIE) is considering two new issues, according to the report published Thursday at the group's Montreal meeting in May and June.

Both topics include the first review of ICH's 1997 General Clinical Trial Guidelines and a new directive on pediatric extrapolation in clinical trials proposed by the US Food and Drug Administration (FDA).

The ICH Assembly also adopted brainstorming tables for both topics and the FDA proposed to lead informal working groups to finalize concept papers and develop business plans to move forward with the guidelines.

During the meeting, the ICH Assembly also voted to approve the China Food and Drug Administration (CFDA) as a regulatory member and the Cooperation System for Pharmaceutical Inspection (PIC / S) as an observer of the group.

Progress in other guidelines

The minutes also detail the updates submitted to the ICH Assembly on other guidelines at different stages of development or review.

For the ongoing review of its Guidelines on Carcinogenicity Studies of Rodents, ICH S1 (R1), the Rapporteur of the Working Group of Experts informed the meeting that 40 carcinogenicity assessment documents have been compiled and summary reports of the regulatory authorities and the document is expected to reach Step 2a / b in June or November 2018.

The EWG of the forthcoming directive on non-clinical safety trials for pediatric medicines (S11) also indicated that it expects to finalize a Phase 1 document before the ICH meeting in Geneva, November, in November.

ICH guideline E17 on multiregional clinical trials is also expected to reach Stage 3 at the Geneva meeting and to reach Stage 4 at the meeting based on the result of a 5 6 days to review the comments in the guide.

Regarding the technical and regulatory considerations of ICH, P12 for the management of the life cycle of pharmaceuticals, the Assembly noted that the Phase 1 document should be subject to a legal review for the EU, here in the middle September 2017 before members can decide to approve the document for Step 2.

The informal working group of Guideline E19 for the optimization of safety data collection also reported that the guideline is expected to reach the first step in November 2018.

During the meeting, the ICH Assembly also approved work plans for the E2B Directive (R3) on the electronic submission of individual case safety reports, the M2 Directive on electronic standards for transfer, the M9 Directive on biopharmaceutical based products in the biopharmaceutical classification system and the M10 Directive on the validation of the bioanalytical method. It is also expected that the M9 and M10 Guidelines will reach Stage 1 in June 2018.

Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

The US Food and Drug Administration (FDA) is giving more and more rapid reviews through accelerated regulatory channels, but a new article in the British Medical Journal found a stronger association with these accelerated likelihood of labeling related to safety, accelerated paths.

In their 15-year data analysis, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Regulatory, Therapeutic and Legal (PORTAL) Program at Brigham and Women's Hospital and Harvard Medical School found that the fastest drug approvals had a higher percentage of tag changes related to safety than those approved for non-accelerated routes.

"More research is needed to understand the underlying factors of the process that contribute to the differential rates in the safety changes that were observed in this analysis," the authors added. "Policymakers are likely to need to ensure that these channels are not overused, that there is sufficient oversight of post-approval compliance approved by these channels, and that patients and clinicians are fully exposed to the risks associated with the widespread use of accelerated development and channels of regulatory review in the approval of new drugs. "

With the implementation of 21st Century Curative legislation, more treatments are expected to receive rapid approvals, especially regenerative medications.

The authors point out that increasing safety tag changes underscore the importance of accelerated follow-up of approved drugs "to help identify emerging problems that require a change in the safety tag as soon as possible," write the authors.

And while drugs that accelerate approval usually include a statement about "clinical benefit ... not established" because of "dependence on an incomplete validated measure," the authors suggest that there must also be formal requirements for manufacturers warn patients about the higher rate of subsequent changes in the safety labeling of drugs approved by channels of accelerated adoption, fast path or priority.

The authors also point out several limitations to their research, including that the rate of safety changes "does not provide a qualitative assessment of the clinical relevance of a particular change.

"For example, adding the" risk of serious cardiovascular events "to the boxed warning of a label in which already had cardiovascular outcomes mentioned could have less clinical impact than the addition of new psychiatric secondary effects that were not included in this section the label, "they write. "Such a qualitative analysis of label changes is complicated by the fact that in some cases the FDA only indicates that a change has been made, but it presents the whole section of the label and in others it emphasizes or italicizes the text but does not indicates what has been changed The FDA's clarity about the exact nature of each label change and the number of changes each month would be helpful in resolving these issues.

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018

The International Forum of Pharmaceutical Regulators (IPRF) and the International Program for the Regulation of Generic Drugs (IGDRP) have agreed to consolidate their work in a joint initiative to be operational in January 2018.

According to a summary of the 5th IGDRP meeting in Ottawa in June, the IPRF Management Committee and the IGPRR Steering Committee expressed their support for consolidating the IPRF and IGPRR initiatives to better address the issues Complex and challenges faced by regulatory authorities and organizations.

The consolidation of these two regulatory collaborations should allow for a shared vision for information exchange and regulatory cooperation, maximize synergies and avoid duplication efforts, create a regulatory center for pharmaceutical products that covers all Allowing for closer links with initiatives to simplify the many forms of international regulatory collaboration and improve governance for management committees and technical working groups.

The Consolidated Management Committee intends to hold its first face-to-face meeting in June 2018.

"Given the imminent consolidation of the IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future," said IPRF.

In addition, the International Council for Harmonization (ICH) Assembly approved a proposal by the IPRF Management Committee that the ICH Secretariat provide support services to the IPRF as of 1 January 2018.

"The Secretariat's support services will cover the needs of the future consolidated entity IPRF and IGDRP," the group added.

The next meeting of the IPRF Management Committee will be held on 12 and 13 November 2017 in Geneva, Switzerland.

Regulatory Recon: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 July 2017)

On the cover: USA

•     FDA accepts the gene spark BLA therapy (endpoints) (press)
•     Big pharma buys in crowdsourcing for drug discovery (by cable)
•     Large pharmaceutical companies spent on share repurchase, but R & D? Not so much (New York Times)
•     Pascal Soriot remains AstraZeneca (Financial Times) (final points)
•     FDA rejects Amgen romo anti-osteoporosis drug as rival Radius surprises with new CEO (Fierce) (PharmaTimes) (Presse)
•     The FDA is firmly committed to the partial coverage of Repros Therapeutics struggling with a large trial application (endpoints)
•     CAR T cells "very exciting" as "living medicine" (Medscape)
•     The new NIH report found a low morale, persistent concerns about patient safety (Washington Post)
•     Gilead rich in species should consider taking Incyte, but it will not be cheap (fierce)
•     In truth, Robot will raise 20 million sterile mosquitoes to free California (MIT Technology Review)
•     McCain surgery delays vote on health care; The recovery may be more serious than previously thought, according to experts (New York Times)
•     US health insurance companies want the proposal to be dropped Senate cross-law (Reuters)

In Focus: International

• This secret clan wants to beat the world's biggest drug makers (Bloomberg)
•     The participation of the increases of the meeting of the regulatory committee of EMA non member of the EU ($ type of leaf pink)
•     Shire boss said stock price is at odds with the range of drugs (Financial Times)
•     TGA Approves Roche Ocrevus for Progressive Primary Recurrent MS (Press)
•     The government has earmarked more than £ 120 million for Global Health Research (UK DOH)
•     Indian pharmaceutical companies should increase investment in R & D (Economic Times)
•     Despite pressure on prices, India's pharmaceutical exports to the US Could increase during the year 18 (Business Standard)
•     The implementation program of the clinical inspection program of clinical trials of Chinese regulations (Emergo)
•     Does WHO's revised standards mask safety signals in vaccines? ($ -pink sheet)
•     Quebec expects $ 1.2 billion savings with new drug market (Bloomberg)
•     Brexit talking about the second round: what are the key issues? (Bloomberg)
•     The pharmacist must know the unitary European patent in the light of Brexit (Pharmafile)
•     Street vendors Port-au-Prince pills (NPR)

Pharmaceuticals & Biotechnology

• FDA Classification on Opioid Prescription Education (MedPage)
•     I had the wrong medication. And a $ 2 help band. (New York Times)
•     With cancer screening, better safe than sorry? (New York Times)
•     This is not the first American opiate additive crisis (Bloomberg)
•     Can the FDA climate to be too good? ($ -pink sheet)
•     The FDA determined that deuter compounds are different NCE orphan drugs compared to non-deuterated versions (FDA Blog Law)
•     Back to the roots of Ipsen (BioCentury)
•     For Alsonex target the complement system C5a for the treatment of ALS (BioCentury)
•     CAR-T therapy: non-compliance with publication specifications can not prohibit patient use (pink leaves $)
•     As part of the taxpayer-funded research, Sanofi's boss says he has never rejected a fair price request for Zika (fierce)
•     Novartis says Cosentyx is safe and effective for five years (PharmaTimes)
•     Five questions to ... Austin Biotech businessman Laura Bosworth (Xconomy)
•     TherapeuticsMD presents the CRL data with FDA (Seeking Alpha) (Presse)
•     More fake Avastin found, this time in Cyprus (Fixing Industry)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

• CymaBay stocks get a rebound on positive data PBC PHII (end points)
•     The Non-Alcoholic Fatty Liver Test / EHNA Phase II Can-Fite with Namodenoson to Begin Recruiting Patients Following the Conclusion of a Successful Clinical Researcher Meeting (Press)
•     Onda Life Sciences is launching Phase 1b / 2a clinical trials: PRECISION-HD1 and HD2-precision in patients with Huntington's disease (Press)
•     Alzheon presents new data for the leading candidate ALZ-801 in the new Ministry of Agriculture and long-term clinical efficacy at the International Conference of the Alzheimer's Association (Press)
•     Merck announces presentations of clinical data and the real world at the International Conference of the Alzheimer's Association (Press)
•     Symbiomix Therapeutics announces the publication of key data for the Solosec research for the treatment of bacterial vaginosis (Press)
•     Perrigo announces final approval of the FDA for its generic version evaluated by the first envelope of AndroGel®, 1.62% packages (press)
•     Impax Announces FDA Approval of Its Generic Tablet (Methylphenidate Tablet) Reviewed by AB Generic CII Rating (Press)

Medical Devices

• Sailing HIV Melanoma Assays to Ensure Regulator Supply (GenomeWeb)
•        Mobius Bionics sells the first use of the prosthesis bionic arm LUKE DEKA (MassDevice)
•        Study: cybersecurity attacks create a risk of manipulation of medical data, devices (MassDevice)
•        Five-year data show that InterStim Therapy (TM) offers efficacy and quality of life improvements for long-term sustainable bladder hypertensive patients (Press)

US: Assorted & Government

• Biosimilars In Medicare payments: CMS Signals will change ($ type of pink sheet)
•        The hymn meets Insys a "creative" scheme to gain the return of its analgesic properties (STAT)
•        Governors of both parties denounced the Senate bill repeal proposed Obamacare (New York Times)
•        The latest Senate health plan cuts costs for chronic diseases (KHN)
•        The marginalized health care lobby hinders the Republican health effort (Reuters)
•        Sometimes it is forgotten in the express warranty (Law of medicines and devices)
•        Calif. Nerve strikes When choosing cardiac surgeons with the highest patient death rates (KHN)

Upcoming Meetings & Events

•     FDA Advisory Committee Calendar

Europe

• Gerresheimer allows the safety solution of the West syringe (Reuters)
•        The best 'Brexit-tested' tips to tackle the most difficult of EU production (Forbes)
•        Pierre Fabre guarantees the Italian distribution rights for Aprotecol de Noventure (Pharmafile)
• India
• Site of the first test laboratory devices in India in Gujarat approved by the Ministry of Health (Pharmabiz)
•        Alembic Pharma Opens Rs 300 Million Rupees Unit in Cancer of Gujarat (Economic Times)
•        Alkem Laboratories Plant Eliminates FDA Inspection (Economic Times)
•        The pharmaceutical industry South has great potential in the production of medicines against chronic disease: S V Veeramani (Pharmabiz)
•        Pharmaceutical sector is a major beneficiary of GST because cold chain materials become problems Dr Piyush Gupta (Pharmabiz)

General Health & Other Interesting Articles

•     3-D-Printed Artificial Heart Beats as the real thing, but still not widely used (MIT Technology Review)

Regulatory recognition is our daily press conference on intelligence to regulatory space, bringing the best new regulations around the world. Every Monday through Friday, we want to get you the latest moments in the approval of new developments, meetings, legal and policy, regulations and guidelines, as well as the latest trends that can influence regulatory professionals and the industry in which they work.

FDA Releases Annual Report on Biological Product Deviations

The United States Food and Drug Administration's (FDA) Center for Research and Evaluation of Organic Products (FDA) on Wednesday released its annual summary of manufacturing errors reported by organic products, blood and its components, human cells , Tissues and products based on cellular tissue and (HCT / P).

During the year 2016, CBER reported having received 51,229 diversion reports that reached its notification threshold, an increase of 10% compared with fiscal year 2015, only slightly up to 50 598 differences reported during 2014.

The vast majority of these reports were from blood and plasma manufacturers (50 319), with the remainder coming from authorized manufacturers of biologicals (651) and HCT / P (259).

Almost all of the increase is attributable to the higher proportions of plasma sources and blood transfusion centers (Additional Report 4545), while organic food manufacturers have submitted only 93 reports and additional HCT manufacturers / P only three reports have been submitted Over the previous year.

The agency also says it has seen an increase in the number of reporting institutions increasing from 1 907 to 2015 to 1950 with fiscal year 2016, including three other manufacturers of allergens, five other blood products and manufacturers five in vitro diagnostic manufacturers ( DIV).

The report also details issues most frequently for non-blood products authorized by CBER, which include allergen products, blood derivatives, IVD, vaccines, and HCT / Ps approved.

Among reports on products not allowed in the blood, 50.7% were for products that did not meet the specifications. Quality problems and distribution control accounted for 14.4% of reports, and other related issues for processing controls, labeling, testing and incoming material accounted for less than 10% of reports.

For vaccines, which accounted for the highest number of reports in this category, the FDA says that increased product ratios do not meet specifications, most of which relate to the appearance of the product. The FDA also claims to have seen an increase in reports of vaccine stability flaws, broken or cracked bottles in shipments and equipment cleaning procedures, but noted a decrease in the number of reports related to test problems.

The FDA also said that it recorded an increase in the number of reports related to DIV accredited CBER, mainly related to unexpected reactions in trials, bottle bottles or containers and products received upside down or on its side in its transport container.

For allergen products, the FDA claims to have received a similar number of reports compared to fiscal 2015, 73% involved the discovery of a precipitate in an allergen extract.

Global Harmonization Initiatives, FDA's User Fee Programs

Global Harmonization Initiatives, FDA's User Fee Programs, Pediatric Legislation, Conditional Approvals, Quality Certificates and a Preview of June

Background papers in recent weeks have highlighted a variety of global harmonization initiatives, including the benefits of a new regulatory tool to improve operational flexibility when changes are introduced after approval and progress of activities Pediatric regulations of the FDA and the EMA. Other articles have introduced changes and the impact of the industry PDUFA and MDUFA GDUFA, regulatory forms to accelerate the review of new drugs and the process of sending electronic common technical document (eCTD) for medicines traded internationally.

Harmonization

Government agencies, non-governmental organizations and professional organizations play a role in harmonization and regulatory convergence in order to align regulatory requirements and adopt internationally recognized guidance documents, standards, techniques and principles, as well as Best practices and procedures. In its article "Regulatory Harmonization Initiatives," Kumar, Barras and Lau provide an overview of global regulatory harmonization initiatives and address how various regulatory agencies and other organizations are working to improve access to pharmaceuticals and improve Medical quality and through internationally harmonized inspection standards.

Considerable progress has been made over the last two decades in the development of medicines for the pediatric population and clinical trials for the test. The legal requirements and harmonization and convergence efforts between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set the global stage for the expansion of this effort. SANGUEDOLCE and Mulchan have pediatric regulatory activities performed by the FDA and the EMA and emphasize worldwide harmonization efforts, discussions and regulations for pediatric clinical trials in their article titled "Regulating Pediatric Studies the Point of View of the European Union and the United States. "

The International Council for Harmonization (ICH) has developed a vision for the harmonization of quality systems throughout the product life cycle, focusing on an integrated approach to risk management quality and science. In its article, "Post-ICH change management approval agreement Q12: benefits for consumers, regulators and industry", Pazhayattil Sayeed-Desta Iyer and discuss the latest draft ICH Q12 and importance of harmonization Of regulatory requirements across regional borders. The authors explain how the post-approval change management protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Policies and guidelines

Prior to the adoption of the Prescription Drug Use Act (PDUFA), the FDA has suffered delays in its long-term medication approval process to review and approve submissions. These delays have prevented companies from all over the world to launch approved drugs in the US market in a timely manner. The industry and the FDA have been frustrated by the slow approval of the drug. In the article, "FDA user payment programs" Gottfried Maguire Chooi, Eldridge and Gottfried provide an overview of the major changes ahead for the major payment programs of FDA users (VI PDUFA MDUFA GDUFA IV and II) for the period 2018-2022 and discuss new performance goals, additional FDA commitments according to the industry and how these changes can have an impact on various types of industry presentation strategies.

The generic industry and the generic market have changed considerably in the last decades with the increase in the number of applications for Abreviada de Nuevos Fármacos (ANDA) and a number of foreign institutions that currently manufacture generic drugs. As a result, the FDA's generic drug program has limited resources and can not follow the new generic drug review and approval process. In his article, "Generic Drug Users Act (GDUFA): General Information and the proposed changes for the year 2018," Mark Lantz explored GDUFA aspects promulgated by Congress as part of the Safety and Innovation Act The Food and Drug Administration (FDASIA), including costs, changes in the FDA to accelerate the review, objectives and changes and impacts GDUFA proposed in the first five-year phase, ending in 2017.

The FDA reviews new medical device applications and regulates medical devices on the market. In 2002, the FDA has authorized to charge tariffs to industry users to facilitate their examination of medical devices regulators activities, responsibilities and comply with their commitment to Congress with regard to timely application Effort resources for medical devices to The patients who need it. In the article titled "Navigating the Fee Act of Using Medical Devices (MDUFA)" Gottfried et al examined the benefits to FDA and industry derived medical devices of the "user fees" allowed by the MDUFA and subsequent steps Reauthorizations.

Providing medical care to the civilian population during the war and crisis is a complicated task. The Syrian war has had an impact on the health system in Syria and neighboring countries. Sahloul discusses the challenges facing medical personnel working with refugees in Syria and provide pharmaceutical products. It describes the relevant policy and advice on drug supply and quality in its article entitled "Challenges for the supply of pharmaceuticals to Syrian refugees."

Before a drug for human use is allowed to enter the market, it must be studied extensively to ensure its safety, quality and effectiveness. However, health professionals and patients are increasingly dependent, many suffer from deadly and debilitating diseases for faster access to new medicines. In response, regulators have developed a number of ways to accelerate the review of new drugs and acquire conditional approvals (CAs). In its article, "Conditional Approvals for Early Access to New Drugs," emphasizes Arora conditional approvals (CA) and conditional marketing authorizations (CMAs), as developed in several jurisdictions, to provide faster access to new drugs . The author explains the details on the regulatory requirements for obtaining CA in the European Union (EU), Japan and the United States.

Clinical trials in Regulatory Affairs, regulatory dossiers for small molecule drugs are incomplete without presentation of certain regulatory certificates, an important part of module 1 of the electronic common technical document (eCTD) filing process. In its article "Quality Certificates for Small Pharmaceutical Molecule Applications for International Regulatory Filings," Jain provides an overview of the general requirements and problems to regulate practitioners find while organizing a variety of certificates requests for pharmaceutical drugs Small molecules marketed internationally in the EU, USA, Canada, Australia and Japan.

Regulatory research

According to the sources, there is an increasing threat of bacteria that can resist all or almost all antibiotics. Nowadays, microbes seem to exceed the capacity of science to develop new human defenses. New antibiotics are desperately needed. In his article "The Unrecognized Heroes of Medicine," Sherman presents readers Boyd Woodruff, a legend in the field of microbiology, and discusses his revolutionary achievements in the development of antibiotics and Merck Research Laboratories.

Background articles coming in June

Feature articles for the entire month of June will provide an overview of the process for the application of new drugs (DNA) in Egypt, various types of FDA inspections, computer approaches to support analysis of deficiencies and application (IDMP) nomenclature conventions for biological and biosimilar products and the challenges of risk management in the medical device industry. Look for these products in June.

Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review;

Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 2017)

 Focus: United States

• UnitedHealth and sign agreement to explore Merck's Linking Drug Performance Payments (CNBC)
• Impulse Industry: Excess Aging Background Lines Imposed (BioPharmaDive)
• Kite Receives Priority Review of FDA for Treatment of RCA-T for Aggressive Non-Hodgkin's Lymphoma (Press)
• The mortality rate of Alzheimer's disease in the United States has increased dramatically in 15 years. Why? (Washington Post) (Reuters)
• Gottlieb: FDA hiring froze, plans to increase competition from generics come (Focus)
• Generics Copaxone: Who will win the first exclusive affiliates? (Warning)
• FDA Panel supports Epogen biosimilar Hospira 14.01 Vote (Focus)
• The reporter lodged a complaint against the FDA's approval for Sarepta (Boston Biz Journal)
• One quarter of American babies with congenital malformations related to Zika was born in New York (NYTimes)
• The proposed budget would reduce Trump's $ 2.2 billion in global health spending (NPR)
• The J & J USA game is not likely to be above the OTC (pink information-$) (Fierce)
• HHS action on drug prices: here is the price of the secretary who is listening (Rose- $)
• Biosimilar advisory committees remain smoother, even with regard to Lo Mismo (leaf Rosa- $) remain
• As the FDA seeks to speed up the review of two other political experts want to limit drug prices accelerated win an OK (Endpoints)
• Drug addiction experts questioned the suggestion to limit FDA opioid prescriptions (Modern Healthcare)
• SURVEY: Medical device manufacturers to be pirated wait, but few do anything (MassDevice)
• Big pharmaceutical and social media: how to avoid problems with the FDA (Forbes)
• Two years later, what has Apple achieved ResearchKit? (STAT)

Approach: International

• Update of the seventh session of the World Health Assembly on 25 May (WHO)
• uperbugs in the supply chain (Pharmafile)
• The German pharmaceutical market has established stable growth (PMLive)
• SMEs Leverage the EU's centralized procedure and scientific support EMA (Pink information- $)
• The plan that generic drugs Modi worries health experts, the Indian pharmaceutical sector (Reuters)
• The former Americans. Of AbbVie. Humira's sales are on the edge of the precipice. Analysts (Fierce), but no panic, say
• movement of the multinational pharmaceutical industry to stop generic registration before the patent in Russia (PharmaLetter- $) occurs
• Tip-Toes FDA in China to push data integrity, harmonization (Rosa sheet $)
• Three negative opinions of the CHMP - but who received an advantage? (SCRIP- $)
• India Cipla low investment in biopharmaceuticals, sharpens focus on breathing (Reuters) (Endpoints)
• Why biosimilars are changing the pharmaceutical industry (EPR)
• The FDA and EU supply chains have doubled inspection of Asian pharmaceutical products (pink information- $)
• Clinical studies conduct: China steps to facilitate the entry of new drugs (color Pink Leaf- $)

Pharmaceuticals and biotechnology

• Harpoon Therapeutics reaches $ 45 million in series B for work I-O (Fierce)
• the Celgene oncology head on ASCO, Revlimid, and the increase in the value of triplet combinations (PharmaLetter- $)
• Safety Profile ozanimod help to bring to the market multiple sclerosis, says Celgene (Fierce)
• FDA Drug Safety Podcast: The FDA does not identify any adverse effects to date with brain retention of gadolinium-based contrast agents for magnetic resonance imaging; Continuation Review (FDA)
• The market for ovarian cancer drugs (Nature)
• Shire quietly stops new investments leaving Baxalta Ventures (Boston Biz Journal)
• Rendezvous: FIIM, Merck, Chromocell, Kymab, GW Pharmaceuticals, Fix Fortuna and Pattern (SCRIP- $)
• AstraZeneca has launched a nationwide voluntary recall of a batch of BRILINTA 90 mg professional sample bottles due to report another drug in a bottle of this batch (press)
• Patient Partnership Group Rare Disease Options Cell Business Model / Gene Therapy (SCRIP- $)
• Constellation Pharmaceuticals Hires Jigar Raythatha as CEO (PharmaLetter- $)
• Does the FDA change its interpretation? (FDAZilla)

Pharmaceuticals and biotechnology: study results, deposits and denominations

• Chronology delayed by Raxone Santhera in DMD (BioCentury)
• Abeona Therapeutics receives orphan designation from the FDA for gene therapy (PRT)
• Anika announces the first patient enrolled in an additional phase III trial of CINGAL for the treatment of knee pain associated with osteoarthritis (press)

Medicalequipments

• New roles for medical devices in the fight against antibiotic-resistant superbugs (MDDI)
• Blood-based breast cancer screening can help prevent biopsy (Forbes)
• Most counterfeit contact lenses are contaminated, according to the FDA (Industry Securing)
• Ethicon J & J states the economic analysis of data in Dermabond Prinéo (MassDevice)

United States: Assortment and Government

• At Trump's initiative, states are trying to include Medicaid in conservative directions (Washington Post)
• Extended causal fault condemns another failure with claim (drugs and devices Act)
• n the race to develop telemedicine services, be aware of legal problems (MDDI)
• Mylan Institutional LLC v. Aurobindo Pharma Ltd. (Fed. Cir. 2017) (Patent Docs)
• The Consumer Advocates Coalition Challenges Notifications FDA's Final Rule GRAS (FDA Blog Law)
• The "quick search" of health care: foundations help consumers maintain a balance and a mirror for the health system (Health Affairs blog)
• Patients trio continues Pfizer, Bristol-Myers, claiming they suffer Eliquis soft pedal strap (fierce)
• Biogen Asking the Judge to File Negative Antitrust Drug Lawsuit ($ Law360-)
• Pfizer said the expert testimony in the game that Celebrex unreliable ($ Law360-)

Upcoming dates and events

• Schedule of the FDA Advisory Committee
• Subcommittee on Advisory Committee on Pediatric Oncology on drugs; opinion
• Meeting - 21-22 June 2017
• Advisory Committee on Vaccines and Related Biological Products; Notice - July 28, 2017

Europe

• Hepatera: PRIME eligibility scheme for Myrcludex B by the European Medicines Agency (Press)
• Patient safety in the NHS: culture change agents (Harvard patent of health)

Asia

• Chinese group buys James Bond brand condominiums (Bloomberg) ($ Law360-)

India

• Diagnosis agappe dressed Hitachi Chemical Company (Economic Times)
• Government identifies ADR 9 additional centers in district hospitals to expand PVP in the country (Pharmabiz)

Australia

• Reference: Examine 75 standard cells derived from TGO cord blood progenitor hematopoietic (TGA)
• tablets 10 mg BTC rosuvastatin - Reminder (TGA)
•  BTC Paracetamol Tablets - Reminder (TGA)
•  Valium (diazepam) tablets 5 mg tablets blister of 50 tablets - Reminder (TGA)
•  Apotex pantoprazole tablets 40 mg - Reminder (TGA)

Another international

• Brazilian doctors use fish skin to treat burn victims (Reuters)
• General health and other interesting items

Symptoms of celiac disease are more likely to be resolved in children (Reuters)
Michael Bliss, a historian who misspelled the myths of insulin discovery, died at 76 (New York Times)

WHO Officials Offer Opposition to Value-Based Drug Pricing

Officials from the World Health Organization (WHO) told reporters at an information session on Thursday that the agency has serious reservations at prices based on pharmaceutical prices.

"What is the value of life? This structure is good for luxury items, because you have a choice ... if I am sick of cancer, what is the choice? We believe value-based pricing is impossible for products that are indispensable, "said Marie-Paule Kieny, Deputy General Manager of Health Systems and Innovation, which he said.

Value-based fixing systems, such as the UK's National Institute of Health Care, decide what is price-paying and price-adjusted. In general, NICE estimates that interventions costing the National Health Service in the UK less than £ 20,000 ($ 26,000) per year of QALY are cost-effective.

Kieny spoke after a meeting of about 200 stakeholders from countries around the world in the first Just One Day Forum in Amsterdam this week sponsored by WHO and the Ministry of Health, Welfare and Sport of the Countries -Bas.

He called on countries to increase transparency in drug prices because "countries sometimes think they have the best deal and if too many countries believe, there is no movement or exchange of information ".

And although Kieny acknowledged that "innovation is not free," he also said the discussions should focus on "the real cost of R & D [research and development]" and the cost of failure, As well as set up price systems that a payer is willing to pay.


A new study published this week on the cost of anticancer drugs found worldwide that even though prices are the highest in the US, are the least affordable in India "by a large margin. "Despite falling prices, anti-cancer drugs are less affordable in middle-income countries than in high-income countries.

. Dr. Suzanne Hill, Director of Essential Medicines and Health Products WHO Kieny reiterated points about value systems, adding, "Who decides what value? He also said that the forum "is our first attempt to launch a program of action to understand the factors that determine the current structure of prices are."

He insisted on the forum of interest for collaboration between governments in "scrutinizing the horizon" or evaluating products in the industry for what is important and what is worth paying in the future , And the need for WHO to develop a list of vulnerable essential drugs. Like those of scarcity all over the world.

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

No one knows what is going to look like British pharmacovigilance after the UK left the EU and uncertainty puts many residents qualified person responsible for pharmacovigilance (QPPV) in the UK in a precarious situation.

According to the independent academic research unit on drug safety in the UK, which met last week on the subject of pharmacovigilance post-Brexit "At worst, it will cause a serious blow to British pharmacovigilance" as the Pharmaceutical companies "will not be required to carry pharmacovigilance in the UK and can not be expected to pharmacovigilance providers from the UK to carry out these studies."

Currently, the European Medicines Agency (EMA) runs the Pharmacovigilance Risk Assessment Committee (PRAC), which uses two members from each Member State and has been chaired since its inception in 2012 by the Agency June Raine regulation of medical products And UK Health (MHRA).

But after Brexit, the UK will not show PRAC, although representatives may present as non-voting observers, as Norway and Iceland do now.

"Pharmacovigilance is above policy," said Saad Shakir, director of the Research Unit on drug safety, last week at the "UK Pharmacovigilance Forum post-Brexit" according to the audio files sent By email to focus.

He also noted the large number of QPPV leaders based in the UK, adding: "We want them to remain part of the EU apparatus. These are national assets." But now, he said, they were "afraid of what is going to happen as the regulations indicate that QPPV should reside in the EU."

Shakir said he could have negotiated a mutual recognition system or a means for EMA and MHRA to continue collaboration.

Ian Hudson, general manager of the MHRA since 2013, said recently, according to Shakir, there had been some discussion about outsourcing regulation work in the UK, but "We do not know what this will look like en -traitance."

Virginia Acha of the British Pharmaceutical Industry Association also noted that pharmacovigilance times at the short end of the rod, as it works so well now.

"There is an enthusiasm to maintain most of the status quo, but the extent to which it is possible to publish Brexit is unclear," the Drug Investigation Unit said in a statement. "Once the UK leaves the EU, it is essential that the current UK-Europe cooperation in pharmacovigilance has improved a lot. Mutual recognition of market research and MHRA EMA is required as part of the Brexit negotiations. "

In addition to this meeting focused on UK pharmacovigilance, last weekend, the European Council established guidelines for the Brexit negotiations between the UK and the European Union.

FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

While the opiate epidemic continues to spread, the US Food and Drug Administration (FDA) seeks to alleviate some of this pain by providing a new draft guidance to generic drug companies looking to develop generic versions of nasal spray that can Reverse opioid overdose.



The draft guide is intended to help companies understand what studies need to be done to get approval for generic nasal spray Narcan Adaptar Pharma, also known as nasal spray of naloxone hydrochloride.

The narcan nasal spray was originally approved in 2015, and the FDA notes that in November 2016, ADAPT has filed a citizen petition (a tool sometimes used to delay the entry of generic drugs) by asking the FDA to refrain from approving any referral (ANDA) narcan nasal spray, unless certain conditions are met, including conditions related to the demonstration of bioequivalence.

The petition comes as the cost of nasal spray and other forms of naloxone continues to rise.

However, the FDA said that the draft directive is, outside this citizen petition, will respond separately. And the project must begin the process of developing and marketing less expensive versions of naloxone nasal spray.

Project Details

The three-page proposal offers two options: o in vivo in in vitro studies, which reveals the specificities and differences in each of them.

For advice on how to develop a generic drug combination product for approval, the FDA stated its policy titled "Comparative Analysis and Comparative Studies Related to Human Factors for Combined Drug Revenue Device presented an ANDA (January 2017) "Which provides the current thinking of the agency in identifying and evaluating differences in user interface design for a generic drug combination product available from its RLD [drug listed in Reference]."

The FDA also clarifies that at the beginning of product development and / or prior to an ANDA offer, applicants must submit to the Office of Generic Drugs, controlled by correspondence and / or request for a pre-ANDA meeting, "the results of Comparative analysis (eg comparative labeling analysis, comparative analysis of tasks, physical comparison of the constituent part of the distribution device) including an overall assessment of all differences identified between the user interface by T A report to the Product as described in the guidelines referred to above.

EMA Board Adopts New Policy on Whistleblowing

In order to encourage complainants and others to feel secure with possible details of the irregularities, the European Medicines Agency's (EMA) Board of Directors adopted a new policy on Monday detailing how the agency handles allegations , Including those that could have an impact on drug evaluation and monitoring.

Since 2013, EMA says it received a total of 43 of these reports detailing various issues and allegations of drug manufacture in conducting clinical trials.

"While there is no formal policy so far, all reports have been treated in accordance with the principles of the new policy," said EMA, noting that this new policy will help EMA to evaluate all reports and coordinate any further investigation In a structured manner, while protecting the journalist's confidentiality.

politics

Any external entity aware of facts that may have an unequal impact on the authorization, supervision and maintenance of human and veterinary medicines may, in the public interest, be reported to EMA at the following address: @ ema.europa.eu reports .

The BMA says that it will ensure the confidentiality of information from outside sources and the identity of the sources and the protection of personal data, these data lead to a later review by the EMA or the Anti-Fraud Office (OLAF) or do not.

"Examples of claims that can be made to understand that the integrity of the data in the studies used to support the marketing authorization can not be invoked.That integrity is essential to confidence in authorized drugs.These problems can occur due to To the formation of poverty, inadequate application of procedures and controls or even falsification of data, "says the policy.

"If there is a fear that irregularities may affect the balance of drug benefits and risks, EMA's scientific committees may consider regulatory action," the agency said in a statement. If the allegations relate to a drug EMA throughout the authorized country, it may, on a case-by-case basis, refer the matter to the national drug agency of that Member State.

The policy, which came into force on 17 March 2017 and prepared in consultation with the European Commission and OLAF, will be reviewed in three years.

FDA Unveils Regulatory Science Progress Report

The report, covering the years 2015 and 2016, points to significant progress in the US Food and Drug Administration (FDA) in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and Improvement of the internal computer tools to support the applications of regulation of scientific examination.

In the clinic

As for non-clinical predictors, the report indicates that FDA researchers have developed a variety of software tools that are now compatible with the non-clinical evaluation of medical products.

"These tools include sophisticated models to predict the carcinogenic effects of some of the ingredients of drugs based on their structural attributes, mathematical representations of the human body (IT ghosts) that can be used to predict the effects of medical devices, such as Radiation exposure, and mechanically-informed pharmacokinetic models to help predict drug exposure in populations where it is difficult to obtain clinical data, "according to the report.

The FDA has also developed in vitro methods and tools to better understand the properties of drugs and biologicals, including vaccines and new tools to support the assessment and development of medical imaging technologies.

Genetic approaches and transplantation have also been used to create animal models that aim to predict the human response more deeply to medical products, and new physical methods and procedures have been developed to support generic bioequivalence assessment of generic drugs.

Clinical evaluation

To better support clinical evaluation of medical products, the FDA engages in the development and evaluation of biomarkers to better predict long-term treatment outcomes or to affect certain patients more likely to be successful treatments.

For example, the FDA notes that its statisticians helped design antibiotic trials that could assess factors related to the development of resistant microorganisms.

In addition, the agency has formed new biomarkers to guide treatment decisions and predict the progression of the disease.

"A long-term research effort to improve cardiovascular risk prediction contributed to the recommendation of the International Conference on Harmonization that the cost-intensive and resource-intensive QT study (required to assess the majority of candidates To drugs) could be replaced by an electrocardiogram - measures based on early-stage clinical studies, "the report said.

He also referred to the FDA's efforts regarding the use of real-world evidence, staff members have expressed concerns in the past.

Through initiatives such as the patient-centered drug development initiative, the Advisory Committee on Patient Commitment to Healthcare Products and the Patient Preferential Initiative, the FDA also incorporates patient views into the Development and evaluation of medical products.

Manufacturing and Quality

The FDA's medical product centers also address scientific issues related to new critical technologies for the manufacture of products to improve the reliability of drug delivery, complex product characterization, quality standards, Approval of product quality and understanding of interactions of regulated products with products of biological systems.

"We have developed the in-house laboratory and computing capabilities to study continuous production with an advanced process control system," the report added. "We have worked with the Biomedical Research and Development Authority (BARDA) to take advantage of continuous manufacturing to minimize vulnerability to domestic, biological and radiological chemistry. We have set in motion the creation of a 3-D printing to understand the factors Which contribute to quality and quality, the performance of implantable medical devices, drugs and combined products made with this new technology.

In addition, the FDA has developed automated approaches to predict critical properties of human stem cell preparations, such as their ability to contribute to bone growth.

Illinois

The agency has launched its "JumpStart" service that allows evaluators to organize, manage and verify the quality of clinical data in ap

European Regulatory Roundup: EU Trade Groups Propose

European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

European business groups propose criteria for deciding the new EMA home

European biopharmaceutical groups have jointly defined the criteria for deciding the new home of the European Medicines Agency (EMA). The three trade groups have detailed their desire that the selection process takes into account six key criteria in a letter to a senior European health official.

The criteria proposed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and Medicines for Europe aim to minimize the risk of disruption when EMA moved to its present headquarters in London, UK, to join Brexit. EFPIA and its co-signatories are publicly out of the discussions about the country that could host EMA post-Brexit, but according to their criteria they describe the type of place they want to win.

Three of the criteria relate to local regulatory capacity. EMA, with the support of the Medicines and Health Products Regulatory Agency (MHRA), business groups want to ensure that the national regulatory agency of the new host country can strengthen their participation in EU activities. This change should not detract from non-EMA workforce, business groups argue, and as such, the local government must be prepared to increase spending.

The three remaining criteria relate to the more general characteristics of the proposed sites. Commercial groups want the Commission to choose a location with easy access to the airport, communicated with the rest of the EU, adequate local hotel capacity and enough space for EMA meetings and events. Finally, the authors of the letter to the Commission to minimize disruption of personal EMA taking into account the availability of international schools, access to labor markets and social security.

The EFPIA criteria echo the cases submitted by some candidates to host the EMA to date. Denmark, the Netherlands and other countries have talked about their regulatory and scientific capacity and the viability of their cities for people traveling to London. If the EMA fails to convince the vast majority of its staff to move to London with him, the regulator could have trouble providing normal services to its small size. Business groups want to avoid that scenario.

As such, while the letter out of the debate on the city that will host the EMA criteria favor the countries of Western Europe that have the necessary regulatory capacity and facilitate resettlement.

The organizations argued their views in a letter to Xavier Prats Monné, Director General of Health and Food Safety Directorate-General. The responsibility to choose a new site for the responsibility of EMA Monne and the rest of the commission. Officials have yet to come up with a timetable to make the decision, but many people affected by resettlement want clarity this year.

Letter

EMA sharing guidelines on the risks to human health of veterinary medicinal products in groundwater

EMA has issued a directive on the toxicological risk that veterinary medicinal products in groundwater pose to human health. The text proposes a methodology to assess whether the concentration of drug in groundwater poses a risk to the health of humans who drink the contaminated liquid.

Today, regulators consider concentrations above 0.1 mg / l as unacceptable. At lower concentrations, no risk is expected and no regulatory action is required as such. However, EMA now consider whether this is the right approach.

The cut-off point of 0.1 g / l is obtained from the limit of detection of the analytical methods at the moment. The development of more sensitive tests can detect small amounts of contaminants has made possible a new approach. Because some drugs may affect concentrations below 0.1 mg / l, EMA believes that using these new, more sensitive tests is useful in making more informed judgments about the risks of groundwater contamination.

The EMA provides the industry uses two formulas that take into account the acceptable daily intake of an active ingredient, the daily consumption of drinking water, the expected concentration in the groundwater and other variables to determine if the risk to human health is acceptable . If the expected concentration in surface waters exceeds

FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

Kathleen Uhl, director of the United States Food and Drug Administration's Office of Generic Drugs (OGD), also unveiled another record year for generic drug approval.

Next Thursday, the House Energy and Commerce Committee will hold a hearing to discuss the reauthorization of generic and biosimilars user payment programs that help fund the agency to accelerate approvals.

The new chair of this commission, Rep. Greg Walden (R-OR), said his committee will take representatives. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) to accelerate generic drugs in the market and create a new Priority Review Program (PRV) bonus for generic drugs to promote development.

The meeting will also discuss the upcoming iteration of the Generic Drug Use Fee Act (GDUFA II), which complements Congressional funding in exchange for more generic approvals at a faster schedule and prioritized revisions for certain generic and Next iteration of Biosimilar User Rates Act (BsUFA II), which will be crucial for the FDA as it reviews an increasing number of 351 (k) applications.

EMT Report

In 2016, OCD FDA approved 73 generic first (an alternative to a branded product, where there were none before) and a total of 630 New Drug Abreast (ANDA) applications and provisionally approved 183 or 87 record set in 2015 for the Number approved in the history of the FDA.

A new FDA staff in contact with the industry, with more than 4800 requests for information, more than 1800 matches and controls more than 1800 complete response letters detailing the comments and questions that must be addressed by the applicant.

In addition, EMT 158 issued new product guidelines, many of which had complex dosage forms, such as auto-injectors, inhalation powders, nasal sprays, topical products and ophthalmic products. There are more than 1,500 in the line guidelines.

The FDA also provided funding to 16 new outside researchers to conduct regulatory science activities that complement the business, and OGD has conducted 87 ongoing external research collaborations, by the end of 2016.

Regulatory Recon: Rep. Cummings

Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations

In Focus US:

• Cummings contradicts Trump in meeting the price of medicines (Baltimore Sun)
• Hundreds of Zika tests that test in US laboratories (Reuters) (Forbes)
• Trump said he will introduce health reforms in early to mid-March (Reuters 1, 2)
• Republican House Leaders Describe Replacement Plan for Obama Health Care Act (New York Times) (Reuters)
• Republican disease proposal would shift the rich to poor money (New York Times)
• Trump's election to lead health agency puts EpiPen 'disturbing' issue (Reuters)
• CMS nominated ducks price problems (BioCentury) (The Hill)
• MP links to foreign reviews of Biotechnology opinion (KHN)
• FDA Issues Frequently Asked Questions About Pharmaceutical Product Development and Manufacturing (FDA)
• CDER 2016 Update for Rare Diseases (FDA)
• A Closer DNA Computer "Smart Drugs" (Phys.org)
• MicroRNA Therapeutics: A New Era for Treatment of Cancer and Other Diseases (Nature)
• Biopharma in 2016 (Nature)
• Regulatory clock: The target product profile for the regulatory tool advantageous but underutilized (Nature)
• CTTI provides recommendations for pediatric clinical trials for antibiotics (Focus)
• GAO: FDA's ability to monitor drug shortages remains a concern
• House Bill aims to add mandatory FDA drug recall withdrawal Arsenal (Focus)
• Industry groups FDA petition on revisions to the intended use rule (Focus)
• 'Tsunami' of Alzheimer's cases among Latinos raises concerns about the costs of care (KHN)
• Amgen hide information from biosimilars, Genentech claims says ($ Law360-)
• Cheapest drugs from Canada? Pharma despise the idea, but the best senators grow HHS chief to deal (fierce)
• Xeljanz Pfizer alone can not match Humira for Abbvie in the big Miss RA head-to-head (fierce) (Presse)
• The Alexion million transaction is largely lost (the street)
• Baxalta buys a big jump in sales in the fourth quarter of Shire (PharmaTimes) ($ PharmaLetter-)

In Focus International:

• Regulation of ANVISA Brazil for personalized sanitary products (Emergo)
• Canada tries to apply a biosimilar equilibrium law ($ -pink sheet)
• EC will not provide a timetable for the phasing out of research on non-human primates (Focus)
• EMA weighs a new guideline on quality requirements for combination products (Focus)
• Daiichi, worried lutantinib ArQule fails in liver cancer stage 3 (fierce) (Presse)
• Martina Schüssler-Lenz elected as new chair of the Committee on Advanced Therapies (EMA)
• Uniqure three-pin gene therapy trial program details (fierce)
• Etanercept biosimilar submitted for approval in Japan (Gabi)
• Takeda buys ARIAD purchase (PharmaTimes)
• Takeda and TiGenix announced a successful test of Crohn's disease (Feroz) (Presse)
• The Mali study shows the effectiveness of the new malaria vaccine ($ PharmaLetter-) (NIH)
• Swiss VC launches new fund with the aspirations of orphan drugs ($ scriptures)
•  Health Canada approves HIV drug Odefsey ($ PharmaLetter-)
• Eisai Comtan and Stalevo markets in China ($ PharmaLetter-)

US: Pharmaceuticals & Biotechnology 

• The common final rule: Many keep or eliminate, but not much new added (FDA Blog Law)
• Oncology Practitioner, Doctor Practice Manager and pay $ 1.7 million to settle charges he billed Medicare for illegally-imported drugs (DoJ)
• Flu vaccine protects half of the time, according to the CDC (NBC) (Medscape)
• Amygdala becomes a drug candidate for Gilead (Ferocious) (Presse)
• The future of successful generic and commercial strategies (Pharmafile)
• FDA asks for comments on pediatric and post-marketing pharmacovigilance of drug use Comments (FDA)
• The return of the one-stop shop model is simply an OCM marketing ploy?
• (InPharmaTechnologist)
• Charles River separates and sells activities OPHRDC (OutsourcingPharma)
• The orientation of phospholipase D in cancer, infections and neurodegenerative diseases (Nature)
• Basic results on apoptosis selective inhibitors of the Bcl-2 family (Nature)
• Inhibitors of JNK stimulate antifungal immunity (Nature)
• How Sanofi blew his chance with Actelion (Drug Delivery)
• AmpliPhi advances the clinical phage for the treatment of microbial infections ($ scriptures)
• FDA extends Boehringer asthma approval to include children ($ PharmaLetter-)
• Sage therapeutic supplies and cushions its own rumors of mergers and acquisitions (fierce)
• Insulet opens a factory in Acton, Massachusetts. (Drug Delivery)
• Zoetis reports that the pace gains, so why do stocks that fold? (The street)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

• The drug giving positive results against chemotherapy for breast cancer AstraZeneca (Pharmafile) (PMLive) (Presse)
• FDA review of Mylan / Biosimilar Biocon Neulasta (BioCentury) (Economic Times)
• Celgene Announces Positive Phase III Oral RAYO Ozanimod Trial in Patients With Recurrent Multiple Sclerosis (Press)
• Perrigo announces FDA approval for the end of hydrocodone bitartrate and oral homatropine methyl bromide solution (press)
• Zydus Cadila receives two FDA approvals (Pharmafile) (Economic Times)
• Aimmune Therapeutics provides an ongoing program update Phase 3 AR101 for peanut allergy based on feedback from FDA (Presse) 

US: Medical Devices:

• Vascular solutions shareholders approve acquisition of Teleflex $ 1M (MassDevice)
• J & J announces the publication of an NEJM study on bariatric surgery for type 5 diabetes mellitus (MassDevice
• FDA Expands Indication for Cryoablation Catheter Freezor Xtra Medtronic (MassDevice) (Presse)
• Medtronic has the Signia stapling system, the innovative surgical stapler for minimally invasive surgery (press) 

US: Assorted & Government:

• UnitedHealth pursued by the United States government on health insurance costs (Reuters)
• The fight against breast implants should remain in court, according to the Brazilian company ($ Law360-)
• Celgene files $ 198.5 million patent application ($ FDANews-)
• Treatment differences persist between low-income workers and high-income workers, even with insurance (KHN)
• Something we can all support: H.R. 985, where Lift Off Left CAFA (Drug Devices Act e)
• Align Technology secures ClearCorrect patent dispute victory

Upcoming Meetings & Events

• FDA Advisory Committee Calendar 

Europe:

• A new framework to stimulate research, innovation and growth? (Dehns)
• Update on the procedure for requesting Conventions and Meetings (AIFA)
• EBITDA and EFPIA supports the ARM initiative on hospital exemptions and require greater transparency in all advanced cell, gene and tissue therapies (EFPIA)

Asia: 

• Difficult to detect, China's bird flu virus may be more common (Reuters)
• Japan supports wireless pacemaker Medtronic Micra (MassDevice) (Presse)
• Medigus wins a nod to the Chinese test of trans-muscular stapler (MassDevice)

 India:

• The support policy needed for the pharmaceutical industry to maintain momentum for growth: FICCI president (PharmaBiz)
• New stents disappear from hospitals to 're-label' (Economic Times)
• Cipla, Serum Institute launches hepatitis B vaccine (Economic Times) 

Australia: 

• MiniMed 640G insulin pumps (TGA) 
• Prima Biomed launches new I-S lead drug test, but needs more money, analysts say (fierce)

 Canada:

 12 arrested in Ottawa for counterfeit prescription drug network (Industry Assurance)

Regulatory Recon: Tom Price Confirmed as HHS Secretary

Regulatory Recon: Tom Price Confirmed as HHS Secretary; FDA Approves Marathon's Emflaza for DMD (10 February 2017)

IN Focus US:

• Tom Price is confirmed as Secretary of Health (New York Times) (NPR) (Washington Post) (SNL)
• Public Citizen's Trump Challenges Liquidation Order (Pink Leaves $) (BioCentury)
• Trump wants the FDA to be moving faster. Your actions have the opposite effect (Vox)
• Rapid drug approvals are risky, but drug companies have another idea that is simply terrible (Los Angeles Times)
• Three decades of pandemic threats can teach us about the future (Health Affairs blog)
• Often, FDA's fastest advocates, patient groups will resist deregulation Trump (Xconomy)
• Heat in pharmacy benefits managers is construction (Axios)
• Americans discourage medical treatment because they can not afford (the Atlantic)
• The HHS internal memory: Some employees will be exempt from ambush FDA hiring (Focus)
• Details of FDA filing requirements for post-marketing safety product combination (focus)
• FDA warns of stomach swelling risks to treat obesity (Focus)
• FDA approves for DMD Emflaza Marathon (MedPage) (FDA) (Reuters) (Presse)
• Senators question Kaleo's $ 4,500 opioid overdose label (Reuters)
• The leader of personalized medicine for the FDA comes out of the initial liquid biopsy Grial (GenomeWeb) (BioCentury)
• The big pharmaceutical industry faces costly failure in the fight against cancer (Financial Times)
• FDA industry petitions against a new standard for intended use (BioCentury) ($ Law360-)
• The pair hope drug Regeneron against eczema due to slow sales of Eylea (Reuters) ($ PharmaLetter-)
• Dozens of new anticancer drugs to improve survival, frustrating patients (KHN)
• Immunomedics a licensing agreement of up to 2 billion with Seattle Genetics (Reuters)
• Slow Medicine: Examining Laser Surgery Tests (MedPage)
• FDA of the United States is probably not "significant" could be largely saved by the order of reducing regulatory Trump ($ -pink leaf)
• Eve of the test: clinical trial cycles continue to rise despite the efforts of industry (Nature)
• How long will we end up with $ 100,000 of cancer drugs? (Cell phone)

In Focus: International

• Operational challenges as European regulator is preparing to leave the UK headquarters (BioWorld)
• The EMA Group recommends that the use of Uptravi Actelion may continue (Reuters) (EMA)
• Highlights of the meeting of the Pharmacovigilance Risk Assessment Committee (PAC) 6-9 February 2017 (EMA)
• Purdue look for a rule that would give him an edge in the Canadian analgesia market (Reuters)
• European regulatory summary: ENVI budget request EMA for Brexit volatility (Focus)
• Brexit could delay major drugs for UK patients, former president claims MHRA (Pharmafile)
• ICH E6 addition integrated display (R1) (ICH)
• Kitov opens on allegations of fraud, takes Commerce (OutsourcingPharma) (Presse)
• Daiichi axis Japanese site R & D and a month after the Indian unity of the abolished research (fiera)
• Seminar Report PMDA medical devices ATC-2016 (PMDA)
• The best forms of electronic application of the EU become mandatory in March (Fair)
• Sanofi's "conservative" India vision for the initial launch of Dengvaxia ($ scriptures)
• A new formulation of a drug for the old can formulate a CCP? The European Court decided (petal of rose $)
• Workers protest against the Merck plant in Goa, will require a salary review (Indian Express)

US: Pharmaceuticals & Biotechnology

• The price of everything and the value of nothing (eye for Pharma)
• Dissuasive Abuse and 3-Year Exclusivity: FDA Decisions Clarify Content and Focus on Exclusively "Abuse" (FDA Law Blog)
• Doctors see gains against an "immediate threat", C. Difficile (New York Times)
• States enter into price issues - Look out down! (Lachman consultants)
• The Indian company Vikshara Trading & Investments Ltd denies FDA inspection, placed on the import alert (FDA)
• More lost than won in the planned R & D change (EP Vantage)
• Momentum NSCLC Merck and Roche, augurs well for scripture combinations ($)
• TRACON slides as brain cancer test loses the mark (fierce)
• Epilepsy discovered in the fish model is promising in the small pediatric clinical trial (NIH)
• Anti-cancer drug for dogs (Paccal Vet-CA1) already approved (FDA)
• What will happen when you have a disease doctors can not diagnose? (National Public Radio)
• BIAL signed a mega-million agreement for Parkinson's disease $ in North America ($ PharmaLetter-)
• Ovid, NeuroPointDX team on rare disease tests (fierce)
• Biosimilars in 2016: Highlights (Gabi)
• Non-biological complex drugs and pharmacopoeia (Gabi)
• 1,000 patients Phase III trial for Armetheon required prior to FDA approval (EPR)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

Aslan reports results of Phase II varlitinib before the IPO (BioCentury) - See more about:

US: Medical Devices

• FDA Approves 7D Reassignment Image Guided System for Spinal Surgery (MassDevice)
• Physio-Control Recalls LIFEPAK15 Monitor / Defibrillator Due to the failure of an electric shock delivery (FDA)
• Alaris syringe pump (high flow), 8100 and AIL sensor kits by CareFusion: withdrawal Class I - Error Alarm (FDA)
• Medicare reduces the cost of knee replacement (This is how it could be counterproductive) (Forbes)
• Cheap method for printing Lab-on-Chip Diagnostic devices and instruments Revolution (Medgadget)
• Silicone trading game Dow Chemical: what it means for medical technology (MassDevice)
• The first patients in the pivotal trial of Echopulse Theraclion device (MassDevice)
• Abbott initiates withdrawal of the vascular closure system StarClose SE (MassDevice)
• BIOLASE announces the launch of the FDA and the worldwide launch of the new Waterlase® Express ™ (All Press)

US: Assorted & Government

• The tax authorities are considering drug prohibition and 20 state prosecution ($ Law360-)
• Nebraska Daubert Order a mile from the expert mouth, but only six inches (law and drug devices) deep
• The federal judge approves the Consent Decree with the California Food Supplement, Regeneca Worldwide (FDA)

Upcoming meetings and events

Europe

• Adapted and reduced clinical program for biosimilars (Gabi)

Asia

• China punishes hospital staff to patients infected with HIV, hepatitis B (Reuters)

India

• Aurobindo sees America plant amid thrust Donald Trump in employment (Economic Times)
• Maha FDA to follow a company based in Mumbai for the storage and supply of illegal orthopedic implants (Pharmabiz)
• A 3-stent implant in India is probably unnecessary (Economic Times)
• Dr. Reddy launches generic drugs in France; Develops its activities in Europe (Economic Times)
• India to allow API companies to request EU quality confirmations online (InPharmaTechnologist) World Health Groups in arms against Roche for the "inhuman" price of its anti-breast cancer drug (trastuzumab Pharmabiz)

Australia

• The implementation of reforms - the public consultation forecasts (TGA)

Zika

• Zika doctor warned Brazil against reducing the guard of congenital malformations (Reuters)
• Another international
• Statement of position on the approval of biosimilars in Latin America (Gabi)
• General health and other interesting articles
• The first genetic transmission in mammals could help the great New Zealand eradication plan (MIT Technology Review)

Regulatory compliance is our daily intelligence report for the Regulatory Affairs area, which gives you the best of the new regulations around the world. Each day of the week, our objective is to present the last moments of the approval of new developments, meetings, legal and political, regulations and guides, as well as the latest trends that can affect the professionals of the regulators and the industry in the That work.

International Generic Drug Regulators Outline Plans for Collaboration Through 2020

Little by little, as the cross-border harmonization between pharmaceutical regulators take shape, the International Program for Generic Regulators (IGDRP) outlined its priorities for the group over the next four years.

Strategic priorities of the consortium include the establishment of a framework for the exchange of information on evaluation among regulators, promoting convergence of technical standards and data and alignment of administrative and regulatory assessment procedures and instruments.

Context

The official launch of the regulation of the International Pilot Project of generic medicines for three years in 2012 explored the possibilities of information exchange and work around generics. Following a successful pilot project and with keen interest to collaborate, a group of regulators launched the International Drug Regulatory Program (IGDRP) have been renamed in 2015.

Participating agencies and organizations include the US Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), the China Food and Drug Administration (CFDA), the Japanese Ministry of Health, Work and Good among others.

The IGDRP currently working on several projects:

Strategic Priorities / Objectives

The IGDRP seeks to carry out a pilot project on the exchange of information among IGDRP members, to research and develop reference documents summarizing the similarities and differences between regulators on issues of "regulatory convergence or harmonization of national guidelines."

The group will also seek to develop tools / mechanisms for the exchange of evaluation reports and other documents may contain confidential business information among regulators.

In addition, the development of databases to identify ASMF / DMF and applications submitted to regulators for registration of generic drugs will be another goal.

The group of more advanced regulatory agencies will also seek to assist people with less technical expertise that allows capacity-building activities (eg joint review of information quality and bioequivalence a generic application) to better understand the interpretation and Implementation of regulatory procedures; In common use.

The performance and impact of the program will be evaluated in the periodic stages according to the December report and an IGDRP logical model and a results matrix and IGDRP has been developed data to help evaluate program effectiveness.