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.