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Regulatory News | 15 September 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Medicines Agency (EMA) has scheduled a meeting to hear what drug developers and other groups have to say about its adaptive pathways program. EMA is presenting the workshop as an opportunity to discuss the lessons of the two-year pilot program and figure out the future of the staged approach to drug approvals.
EMA designed the adaptive pathway to cut the time it takes for patients to gain access to new drugs, specifically by enabling companies to win approval in a restricted population on the basis of limited data. The idea proved attractive to the industry, resulting in 62 companies applying to join the pilot program. However, 42 applicants never made it as far as face-to-face meetings with EMA. Only seven companies received scientific advice. In thinning the field of applications, EMA — and potentially the industry — have learned lessons that will be discussed at the workshop.
The one-day meeting is scheduled for 8 December and designed to cover three core topics. Once the introduction is complete, EMA will spend two hours hearing the views of patients and healthcare professionals on what can be done — and has been done — to ensure adaptive pathways address unmet needs. EMA has set aside the following two hours for a session on “avenues of knowledge generation throughout a medicine’s lifespan,” before the third and final session addresses the role all groups can play in getting drugs to patients now the pilot project is complete.
Officials at the regulator outlined aspects of what they learned in the pilot program last month in a report and guidance document. The publication of those texts followed the completion of the pilot phase and coincided with EMA committing to offering adaptive approvals on an ongoing basis. Now, having given its take on the successes and shortcomings of the pilot program, EMA is gathering drug developers, healthcare professionals, patients, health technology assessment organizations, payers and other regulators to discuss the topic.
Press Release, Workshop Agenda
Emer Cooke is leaving EMA to take up a post at the World Health Organization (WHO). The departure deprives EMA of a senior official who has played a central role in facilitating cooperation between the European regulator and its international peers, but gives it an ally at WHO.
Cooke has worked at EMA since 2002, rising to the position of head of international affairs in 2013. In that capacity, Cooke acted as a bridge between EMA and other regulators and drove forward efforts in mutual recognition and cooperation. Highlights of her stint in the job include the progress of work with the United States Food and Drug Administration (FDA) to ensure regulators on both sides of the Atlantic recognize each other’s good manufacturing practice (GMP) pharmaceutical inspections.
Speaking to Focusin June, Cooke said negotiations had “progressed quicker than we’d expected,” adding that FDA had “just internally clarified ... conditions” that would facilitate the sharing of trade secrets between the regulators. Yet, even after that progress, Cooke declined to commit to timelines for the establishment of mutual recognition, noting that “legal hurdles ... need to be resolved” before the project could move forward.
In taking up the position of head of regulation of medicines and other health technologies at WHO, Cooke has left her colleagues to resolve those issues. The upside, for EMA, is it will now encounter a familiar face when dealing with WHO. “We shall be sorry to lose Emer’s insight and expertise, but are confident that she will continue to further develop the close collaboration between EMA and WHO,” EMA Executive Director Guido Rasi said.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has warned the public about counterfeit HIV self-testing kits and other sexual health products. Officials are worried the use of substandard sexual health products puts individuals and their partners at risk.
MHRA timed the release of its statement to coincide with a campaign by sexual health nonprofit FPA, but the issues raised regarding false readings and ineffective contraception are perennial. Earlier this year, MHRA seized 22,000 counterfeit condoms and 7,000 unapproved syphilis test strips in one operation, a haul that confirmed the potential for harm to the regulator and its partners. The sexual health push at MHRA is an attempt to make people aware of these risks.
“Anyone taking a test without a CE mark risks their own health and that of others,” Cary James, head of health promotion at HIV-focused nonprofit Terrence Higgins Trust (THT), said. “The presence of our logo on a test provider’s website or kit does not mean we endorse the kit. Unfortunately, unscrupulous companies sometimes use the THT logo without permission in order to give their product credibility.”
How MHRA works with its counterparts on mainland Europe to stop such products reaching patients is one of the many questions raised by the outcome of the referendum on Brexit. In its annual report, which was published after the vote, MHRA said it would work with European and global partners “to combat counterfeiting and ensure a more secure supply chain.” The fate of cross-border cooperation agreements between regulators and law enforcement agencies that facilitate such work is unclear.
The Committee for Medicinal Products for Veterinary Use (CVMP) has adopted a reflection paper on the risks to consider before using unauthorized vaccines in emergency situations. Members of the committee see the paper as supporting the work of people responsible for disease control measures.
CVMP is yet to publish the reflection paper, but released a summary following a meeting to discuss and adopt the text earlier this month. The summary describes a paper that uses the process by which marketing authorizations are typically granted to veterinary vaccines to illustrate the dangers of bypassing the standard procedure in an emergency situation. CVMP is keen to discuss the risks posed by the widespread use of vaccines on the basis of incomplete datasets.
In the event of a disease outbreak against which there are no established treatments and vaccines, whether it affects animals or humans, there is often a clamor to gain access to experimental drugs and prophylactics. If CVMP can establish a framework for decision makers to follow in this situation, it could make it easier to decide whether to use the experimental vaccine and lower the risk of an ill-thought-out decision causing further harm.
At the same meeting, CVMP adopted a concept paper that addresses some of the pathogens that can cause outbreaks in animals. The concept paper is a step toward the revision of a guideline on the data requirements for multi-strain dossiers regarding inactivated vaccines against avian influenza, the insect-borne, ruminant-targeting virus bluetongue and foot-and-mouth disease. CVMP also adopted a concept paper on adjuvanted immunological animal medicines.
The UK EU Life Sciences Steering Group, which is led by senior executives from AstraZeneca and GlaxoSmithKline, has met with ministers to discuss how the government can help the industry to thrive post-Brexit. With access to international talent, funding and Europe-wide collaborations, plus free movement of goods and capital, high on the agenda, the demands of the steering group look a lot like the status the UK currently enjoys as part of the EU. Article
Tags: European Regulatory Roundup, Brexit, adaptive pathways, Emer Cooke