European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites

CHMP began reviewing drugs tested at Indian sites in the midst of GCP's concerns

The Committee for Medicinal Products for Human Use (CHMP) undertook a review of the trial on two sites Micro Therapeutics Research Labs India Drugs. The national regulatory authorities asked the CHMP to conduct a review after the Austrian and Dutch authorities found fault with these sites during a Good Clinical Practice (GCP) inspection.

Officials visited sites in February Micro Therapy reported concerns about the survey data used to support applications for marketing authorization in the European Union. This led to 18 national regulatory bodies to ask the European Medicines Agency (EMA) to check whether the findings of the GCP inspectors affected their position on the risks and benefits of the drugs tested on the sites. The CHMP also checks whether the data generated on the sites are used to support active applications and, if so, to determine whether the origin of the results should influence their evaluation.

The review involves a centrally licensed drug, a generic copy of Eli Lilly's erectile dysfunction drug Cialis sold by Mylan. EMA drug approved two years ago on the basis of data showing that it is bioequivalent to the reference product. The review will also assess the risks and benefits of drugs approved by national authorities in light of questions about data generated at sites in the Indian cities of the Chennai and Coimbatore regulatory bodies.

Previous suggests EMA will strongly act against any medication that has been approved based on data generated incorrectly. When EMA found evidence of manipulating electrocardiogram data from GVK Biosciences, he recommended the suspension of 700 products that were based on studies conducted by contract research agency in India for approval. More recently, the agency has suspended dozens of drugs, including many sold by Novartis and Teva Pharmaceuticals, after finding flaws in how the Semler Research Center conducted bioequivalence studies.

Scottish politicians criticize MHRA on transvaginal mesh implants

Politicians have criticized the UK Drug and Health Products Regulatory Agency (MHRA) for its treatment of transvaginal mesh implants. The Scottish government has asked the National Health Service (NHS) to stop using appliances in 2014, but the products remain on the market, it is reported that more than 400 women have received implants since.

Scottish politicians discussed implants after the BBC News reported the continued use of devices. Shona Robison, the ruling Scottish National Party, adopted the debate defining the powers or lack belonging to the government and MHRA and other politicians said a report to be released early next year will contain answers to your questions. However, with a political argument that implants cause "organ damage, loss of a kidney, bladder removal, constant chronic and unbearable pain" and other side effects, the Robison argument has not Managed to soothe all other loudspeakers.

"Due to the problems we are discussing, we have tended to speak on the subject in the most cautious tones. However, last month in the Australian Parliament, Senator Derryn Hinch delivered a speech absolutely Dull in which he criticized doctors And manufacturers neglect women and compared implant mesh scandal with thalidomide, "said conservative politician Carlaw Conservative Party said." I include the MHRA in my criticism. "

MHRA examined evidence of the risks and benefits of implants in 2014 after groups representing patients affected by devices come to him. The regulator concluded that "for most women, the use of vaginal mesh implants is safe and effective." Other regulators have come to similar conclusions.In January, the Food and Drug Administration (FDA) ) Reclassified mesh implants used to repair organ pelvic prolapse (POP) and increased risk devices, but left used to treat stress urinary incontinence products in Class II.

The position of the FDA is broadly aligned with that of the MHRA, which was more unequivocally its support for the use of POP SUI mesh. Despite this, and a requirement that all patients give their prior knowledge before proceeding to an authorization of the mesh implant, the question remains political

FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule to add six bulk pharmaceutical substances to a list of these substances that can be used in the composition and to remove four other bulk substances Included in the list.

If the proposed rule is finalized, the six bulk pharmaceuticals proposed to be included in the so-called bulk carrier list 503A. The FDA Pharmacy Advisory Committee (ABCP) discussed proposed additions and exclusions in 2015 and the committee met three times in 2016 to discuss the inclusion and exclusion of others Substances on the list.

"Due to the time elapsed between the publication of the proposed rule in 1999 and the promulgation of the DQSA [Drug Quality Security Act], the FDA considered it necessary to recommence the development of the 503A bulk carrier list," said The agency In the Federal register of Thursday.

In addition to new additions and exclusions, the FDA is also proposing, through this new rule,

"Due to the time elapsed between the publication of the proposed rule in 1999 and the promulgation of the DQSA [Drug Quality Security Act], the FDA considered it necessary to recommence the development of the 503A bulk carrier list," said The agency In the Federal register of Thursday.

In addition to new additions and exclusions, the FDA is also proposing, through this new rule,

1. 1 Physical and chemical characterization of the substance
2. 2 Safety Issues Raised with the Substance in Compounded Pharmaceuticals
3. 3 Available evidence of the efficacy or lack of efficacy of a drug product combined with the substance, if there is such evidence
4. 4 Historical use of the substance in compounded pharmaceutical products, including information on the medical condition (s) to which the substance was used to treat and any references in the peer reviewed medical literature.

The FDA proposes to examine each criterion and balance it on a substance-by-substance basis in order to decide whether a substance is appropriate for inclusion in the list.

The Federal Register's notice announcing the proposed rule provides additional details on the type of information proposed for each criterion and how the FDA proposes to weigh the information.

Inclusion in List 503A

Based on the FDA assessment and consultation with the Advisory Committee on Pharmaceutical Composition, the agency proposes to include six bulk pharmaceutical substances on the list:

1. 1 Brilliant Blue G, also known as Coomassie Brilliant Blue G-250, as a dye used for staining for visualization during ophthalmic procedures
2. 2 cantharidin (for topical use only), for the treatment of warts and molluscum contagiosum
3. 3 diphenylcyclopropenone (for topical use only) for the treatment of alopecia and non-genital warts
4. 4 N-acetyl-D-glucosamine (for topical use only) for the treatment of hyperpigmentation and other skin conditions
5. 5 dibutyl ester of squaric acid (for topical use only) for the treatment of alopecia areata and recalcitrant non-congenital warts
6. 6 thymol iodide (for topical use only) for ulcerations and skin infections, as well as intrapleural treatment for pleural effusions

Exclusion from List 503A

The FDA has proposed that the following four substances be included in List 503A:

1.  1 oxitriptan (evaluated as a treatment for depression and insomnia)
2.  2 piracetam (evaluated as a treatment to improve cognitive skills)
3.  3 light silver protein (for use as an anti-infective agent for ophthalmic use)
4.  It is approved in South Korea and Japan for the treatment of asthma, keloids and hypertrophic scars, and an ophthalmic solution for allergic conjunctivitis (4), transilast (for the treatment of allergic disorders, Arthritis, dry eye syndrome, keloids and hypertrophic scars )

Regulatory Action Against State Pharmacies

The FDA also notes in the proposed rule that it does not intend to take regulatory action against a government-approved pharmacy, a federal facility or a licensed physician to make a drug using a pharmaceutical Bulk that is not the object of a USP or NF

FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

The Food and Drug Administration (FDA) issued final guidelines on the implementation of the Drug Supply Chain Security Act (DSCSA) on Thursday, but also asks for comments on a new section describing when manufacturers should notify the FDA High risk that an illegitimate product is

.

According to the new section, which is distributed "for comment only", the Agency offers its interpretation of paragraph 582 (b) (4) (B) (ii) of the Food, Drugs and (FD & C Act) , Which obliges manufacturers to make notifications under certain circumstances for products that present a high risk of illegitimacy.

"The FDA interprets this provision as requiring manufacturers to notify (1) the FDA and (2) the manufacturer's immediate business partners (which the manufacturer has reason to believe possesses in the possession of the trading partner a manufactured product or purported to be A product Manufactured by the manufacturer) in three general scenarios:

1. Within 24 hours of the determination or notification by the FDA or a trading partner that there is a high risk that the manufacturer has reason to believe in the possession of an immediate trading partner is a Product.
2. Within 24 hours of the determination or notification by the FDA or a trading partner that there is a specific high risk that could increase the likelihood that the illegitimate product will enter the supply chain of the US pharmaceutical distribution.
3. Within 24 hours of the determination or notification by the FDA or a trading partner that there is "other high risk" as determined by the FDA in the guidelines under paragraph 582 (h).

The new section, "For manufacturers: high risk of notifications of illegitimacy", also offers examples of scenarios involving high risks of illegitimacy in which the manufacturer should make a notification.

In addition to the added section, the FDA says it has made minor changes to FDA Form 3911 and instructions for completing the form.

The finalized parts of the guide, written for the first time in June 2014, are intended to help companies rapidly remove illegitimate drugs from the US market by notifying the FDA and trading partners after manufacturers determine or are notified by the FDA or the FDA Business Partner That there is a high risk that an illegitimate product is.

And as of next November, pharmaceutical companies will have to mark their products with National Drug Code (NDC), serial number, batch number and expiration date in both machine-readable and human-readable formats