European Regulatory Roundup: DG Sante Posts Guidelines on Real Time Release Testing (18 September 2015)

Regulatory NewsRegulatory News | 18 September 2015 |  By 

DG Sante Posts Guidelines on Real Time Release Testing for Consultation

DG Sante has released guidelines on real time release testing (RTRT) for consultation. The guidance is a revised version of the RTRT document that came into force in 2002, since when the International Conference on Harmonisation (ICH) has made multiple changes that affect the topic.

When the European Commission last released guidelines covering RTRT — the application of in-process monitoring and controls to negate the need for end-product testing — it expected use of the approach to be limited to terminally-sterilized products. However, improvements to process analytical technology, quality by design and quality risk management have contributed to a shift in attitudes to RTRT. Effective RTRT is now thought to be superior to traditional end-product testing.

The updated guidelines addresses these advances, while also bringing European advice in line with ICH Q8, Q9, Q10 and Q11. By following the guidelines, manufacturers of finished products, active ingredients and intermediates should be able to establish a regulatory-compliant method of assuring quality through control of critical parameters and material attributes. The Commission is accepting feedback on the draft until December 11.

Commission Notice, Consultation Document

Commission Lays out Strategy for Controlling Veterinary Antimicrobial use

The European Commission has detailed how it intends to curb the improper use of antimicrobials in veterinary medicine. Pharmaceutical companies are expected to play their part in the initiative, notably by highlighting the risk of resistance in advertizing materials and rethinking drug pack sizes.

Advice for manufacturers of antimicrobial veterinary products makes up a small but important part of the 20-page document. The Commission wants the industry to take a responsible approach to the advertising of antimicrobials, specifically by addressing the risks of resistance in their materials and limiting their messages to objective information. Companies are also advised to avoid promotional campaigns that that offer prescribers economic or material benefits.

The marketing advice is one part of a two-part strategy to have manufacturers encourage customers to make prudent use of antimicrobials. The other component calls on the industry to change drug pack sizes and strengths to cut the risk of improper dosing and overuse. In the longer term, officials are looking to drug developers to come up with alternatives to antimicrobials. Vaccines and rapid, affordable diagnostics are two of the areas in which the Commission would like to see investment.

Commission Statement, Guidelines

EMA Finalizes Guidelines on Evaluating Chronic Constipation Treatments

Officials at the European Medicines Agency (EMA) have finalized guidance on evaluating treatments for chronic constipation. The final version features changes made in response to feedback from six groups, which led EMA to amend the title and tweak several sections of the text.

EMA made most of the changes to the draft text it released last year in response to feedback from the Belgian Federal Agency for Medicines and Health Products, the Dutch Medicines Evaluation Board (MEB) and Norgine. MEB noted that the title of the draft made no mention of bowel cleansing, despite the topic taking up a substantial proportion of the text. EMA has changed the title to better reflect the scope of the paper.

Most of the other changes are minor. EMA has added a line to explain that when opioids are used chronically, there is no development of resistance to the constipation the treatment can induce. The regulator also clarified that pharmacodynamic data can be generated in either patients or healthy volunteers. In the draft, EMA said data from both groups were needed. The final text is due to come into force on January 1, 2016.

Guidelines, Feedback

CHMP Agrees to Consider Ingestible Sensor as Qualified Clinical Trial Measure

The Committee for Medicinal Products for Human Use (CHMP) has agreed to consider the use of an ingestible sensor as a qualified measure in clinical trials. CHMP is evaluating the technology at the request of Proteus Digital Health, which wants to see its product used to track medication adherence.

CHMP released an overview of the proposal and its initial response as a draft qualification opinion that is open for consultation until October 26. The text gives an overview of Proteus’ technology, a CE-marked device that is co-forumlated with an active ingredient to create a dosage form capable of communicating when it is swallowed. Proteus thinks such co-formulations could eliminate doubts about whether poor medication adherence is affecting the data generated in clinical trials.

Officials at CHMP recognize the unmet need for such reassurance, particularly in cardiology, neurology and psychiatry trials, and are open to the idea. “CHMP agrees in considering the use of the Proteus technology as a qualified method for measuring adherence in clinical trials,” officials wrote in the draft opinion. The release of the CHMP opinion follows a marketing filing to FDA for a dosage form that combines Proteus’ technology with Otsuka’s antipsychotic Abilify.

Draft Qualification Opinion, More

UK Court Rules Against Pfizer in Closely-Watched Patent Case

A United Kingdom court has ruled against Pfizer in a case relating to the patent protection of Lyrica. The case covered whether the branded version of Lyrica has exclusivity in the treatment of pain, despite having lost patent protection in its original indications of general anxiety disorder and epilepsy.

Pfizer discovered the effectiveness of Lyrica as a treatment for pain after it originally patented the drug. As such, while the original intellectual property rights of Lyrica have expired, the secondary, pain-focused patent is valid until 2017. Pfizer has argued that generic versions of Lyrica introduced as general anxiety disorder and epilepsy treatments by Actavis and Mylan have infringed its pain patent because prescriptions list the active ingredient, not the brand name.

The High Court judge largely dismissed the argument, clearing Actavis of wrongdoing and finding Pfizer liable for making groundless threats of patent infringement. Pfizer is appealing the ruling. The appeal means physicians in the UK must continue to specify the use of branded Lyrica when writing prescriptions for pain treatments. Officials in the National Health Service implemented the measure in March to avoid infringing Pfizer’s patent. With Pfizer appealing, the measure remains in place. 

Court Judgement, The IPKat, Wall Street Journal, Pulse

Other News:

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has upheld a complaint against Northwest Biotherapeutics. MHRA ruled a commercial feature in The Times that Northwest Biotherapeutics sponsored amounted to advertising of an unlicensed medicine, DCVax-L. The vaccine in question is part of the UK’s Early Access to Medicines Scheme. MHRA Notice

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the benefits and risks of the antibiotic fusafungine when delivered as a nasal or mouth spray. Officials at the Italian Medicines Agency requested the review after observing an uptick in the rate of serious allergic responses, including anaphylactic reactions. PRAC Notice

The Estonian Agency of Medicines received three applications to run Phase I clinical trials last year. The small tally is the first time since 2011 that the regulator has received any applications for such early-phase studies and it is only the second time sponsors have made submissions in the past six years. Applications across all phases were up on 2013, but well down on the highs of 2012. Report





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