European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017)

Posted 20 April 2017 By Nick Paul Taylor

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Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Reveals Talks With FDA About Joint Accelerated Assessment Activities

The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation.

EMA has revealed little detail about the discussions, beyond clarifying that they relate to initiatives such as its priority medicines (PRIME) program and FDA’s breakthrough designation. Currently, the agencies have similar but separate mechanisms for accelerating the passage of highly promising drugs through the regulatory process and onto the market.

The context in which EMA disclosed the discussions with FDA provide a clue as to how cooperation on accelerated assessments could move forward and why. EMA mentioned its transatlantic talks in a report on the Quality by Design (QbD) pilot program it started running with FDA in 2011. QbD entails using knowledge of a product and the process through which it is made to ensure quality, rather than relying solely on end-of-line quality control checks. 

That EMA-FDA initiative sought to facilitate consistent implementation of QbD concepts and harmonize decisions made by the two regulators. To achieve this, the agencies ran parallel assessments of applications that featured QbD elements and discussed their positions on the concepts and related regulatory requirements while doing so. EMA thinks it has resulted in "solid alignment" of the agencies’ positions on QbD regulation. 

EMA is now interested in extending its cooperation with FDA to other areas. In its report, EMA put accelerated or expedited assessments alongside continuous manufacturing and "additional emerging technologies" on a list of fields in which it is discussing joint initiatives with FDA. If the initiatives share the intention of the QbD program, they will seek to more closely align how EMA and FDA approach the review of accelerated assessment requests.

EMA Report

EMA Creates Information Security Best Practices for Users of EudraVigilance

EMA has released an information security best practices guide for users of its safety monitoring system EudraVigilance. The guide covers the actions individuals and organizations need to take to minimize the likelihood and impact of security breaches.

Officials at EMA’s Information Management Division expect organizations to adopt "appropriate" measures to protect their information and personal data. Examples of technical and organizational measures EMA wants to see include safety and acknowledgement messages and steps to cut the risk of unlawful access and accidental loss.

Specific ideas put forward by EMA include the implementation of security measures to protect all locations and systems where EudraVigilance data are handled. EMA wants organizations to install antivirus software on all their infrastructure and regularly check if their system needs patching or has vulnerabilities.

EMA’s best practices also cover softer but equally important security measures. These include the education of staff about phishing attacks and the ways people may try to manipulate them to get them to divulge confidential or personal information. Hacking groups including Fin4 have used these approaches to acquire confidential information that could move the prices of biotech stocks. EMA’s advice for countering such attacks centers on education about how to recognize malicious emails and websites. 

The rest of the responsibilities relate directly to users. Some of the best practices apply generally to all online platforms. For example, EMA advises users to change their password regularly and never share it with anyone, particularly if someone claiming to work for the agency requests it. EMA also wants users to create strong passwords that are different from those they use to access Gmail, Facebook and other personal accounts. 

Some of the other user-focused best practices are more specific to EudraVigilance. Responsibility for ensuring the confidentiality of individual case safety reports and rights of the data subjects falls on individual users. If a user learns of a breach related to personal data linked to EudraVigilance, EMA expects them to call its service desk immediately.

EMA Document

Aurobindo Objects to Planned Suspension of Drugs Tested by Micro Therapeutic Research

Aurobindo Pharma has objected to the planned suspension of four of its drugs by the Netherlands’ Medicines Evaluation Board (MEB). The regulator was set to suspend the licenses for the products as part of actions against drugs tested by Micro Therapeutic Research, but Aurobindo has secured a reprieve.

Having been contacted by Aurobindo, MEB will now pause to evaluate information submitted by the Indian drugmaker before deciding whether to suspend its products. Different doses of the products affected by the pause account for 10 of the 12 drugs up for suspension in the Netherlands and the only ones on sale in the country. The two affected Aurobindo products on the Dutch market are different doses of the antifungal voriconazole.

MEB is yet to say what information Aurobindo has submitted to support its argument against the suspension. EMA recommended the suspension of Aurobindo’s products and other drugs earlier this year after concluding studies by Indian service provider Micro Therapeutic Research were unreliable. At that time, EMA said affected manufacturers could keep their products on the market by submitting suitable alternative data. 

Novartis’ Sandoz, the other company affected by the recommendation in the Netherlands, is yet to object or present alternative data. Consequently, MEB has suspended the license for bupropion hydrochloride, its generic version of the antidepressant Wellbutrin.

MEB Notice (Dutch)

NHS Creates Online Platform to Share Data on Medicine Uptake in the UK

The UK National Health Service (NHS) has created an online platform to share data on the uptake of medicines. Officials created the system to show how use of medicines backed by the National Institute for Health and Care Excellence (NICE) varies over time and across the country.

NHS Digital introduced a data sharing initiative dubbed the "innovation scorecard" in 2013 to give local healthcare authorities a way to monitor their progress in adopting NICE recommendations. The new platform builds on this earlier initiative by presenting the data on a data visualization dashboard. Users of the platform can filter by drug or indication.

For example, filtering by sofosbuvir, the active ingredient in Gilead Sciences’ Sovaldi, on the regional utilization screen shows how use per 100,000 people has varied from quarter to quarter and across different regions of England. One chart shows use peaking in the third quarter of the last fiscal year before falling away, reflecting the trend that has affected the product globally. Another reveals the drug is most widely used in the Yorkshire and Humber region.

Press Release, Web Platform, More

Other News:

Lord Prior has said the UK will incorporate EU pharmaceutical intellectual property law into its own legislation as part of the Great Repeal Bill. The bill is intended to ease the UK’s exit from the EU. Written Answer

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Categories: Biologics and biotechnology, Drugs, News, Europe, FDA, EMA, EC, MHRA

Tags: European Regulatory Roundup, EMA and FDA, EudraVigilance, information security

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