EU Regulatory Roundup: UK Reassures Industry it Will Adopt EU Clinical Trial Regulation

Regulatory NewsRegulatory News | 26 April 2018 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Reassures Industry it Will Adopt EU Clinical Trial Regulation Despite Brexit
The United Kingdom has committed to adopting the European Union Clinical Trial Regulation despite Brexit. A government representative in the House of Lords made the promise to head off a potential rebellion that would have pushed for a legislative guarantee that the UK will adopt the regulation.
If all goes to plan with the rollout of the legislation and EU exit negotiations, the trial regulation will come into force sometime during the planned Brexit transition period. However, the potential for this not to happen for a range of reasons has created uncertainty. The European Medicines Agency (EMA) has already delayed adoption of the regulations and, strained by Brexit, could do so again, pushing the date out past the end of the transition. Equally, Brexit negotiations could fall apart.
Faced with these risks, the House of Lords sought to modify the UK’s EU withdrawal bill so the trial regulation will come into force before Brexit day and is therefore transposed into national law. The government nullified that proposal by having Baroness Goldie, its agent in the Lords, provide the “strongest possible reassurance on the UK’s commitment to implement” the regulation.
If the regulation does not come into force during the transition period, “The government will seek to bring into UK law all relevant parts of the EU regulation that are within the UK’s control,” Goldie said. The goal is to create a predictable regulatory environment for sponsors planning to run clinical trials.
Goldie’s reassurance was enough for other Lords to drop the proposed change to the withdrawal bill, but there are limits to what the UK can guarantee unilaterally. As Goldie noted, some aspects of the implementation of the regulation are outside the UK’s control. The UK will only be able to use the shared IT portal that is key to the regulation and participate in single assessments if the EU agrees.
Prime Minister Theresa May’s pitch for the UK to remain part of EMA in some capacity would address these issues, and Goldie referred to that proposal in her speech to the Lords. However, the response from Europe to the idea has been lukewarm at best. Notably, negotiating guidelines adopted by the European Council last month preclude “participation of the UK as a third-country in the Union Institutions and participation in the decision-making of the Union bodies, offices and agencies.”
Debate Transcript
CVMP Revises Finished Dosage Form Guidance to Reflect Supply Chain Globalization
EMA has posted a draft guideline on the manufacture of finished veterinary medicine dosage forms. The guideline updates an existing note for guidance to bring EMA’s advice in line with the emergence of complex, global supply chains.
That motivation is reflected in a section discussing the storage of intermediate and bulk products. EMA states intermediates can be stored and shipped between facilities provided certain precautions are taken. A suitable container must be used and the choice justified to EMA. The manufacturer may need to confirm the quality attributes are unchanged before further processing the intermediate.
EMA expects companies that perform these confirmatory studies to provide details of their tests. The agency takes a different approach to hold time validation for the storage of intermediates, sparing most companies from the need to include details of this work in marketing filings. However, EMA may require such hold time data for biologics and certain other types of product.
The agency is also interested in whether products are stored before final packaging and, if so, under what conditions. Applicants may need to state and justify the maximum bulk product holding times or maximum batch manufacturing time, too. If a product undergoes prolonged storage or processing, EMA expects companies to provide reasons consistent with good manufacturing practices.
The Committee for Veterinary Medicinal Products (CVMP) is accepting feedback on the draft until 22 October. CVMP also used the revision of its position as a chance to adapt the text to legislation adopted since the earlier note came into force.
Draft Guideline
UK Politicians Criticize ‘Wild West’ Nature of Device Sector, Call for Stronger Regulations
Politicians in the UK have called for tighter regulation of medical device safety. The politicians made the comments during a debate into the use of surgical mesh that painted the medical device sector as a “wild west” in which products are used without first undergoing adequate testing.
Sarah Wollaston, a doctor and chair of an influential UK political health committee, led much of the criticism, stating that the size or thickness of mesh devices were changed without testing the effect of the modifications in the clinic. As Wollaston sees it, these changes reflect “cavalier attitudes and assumptions” that medical devices are safer than drugs.
“It strikes me that there has been a kind of wild west out there, with representatives saying, ‘Why don’t you try this one? This is probably going to be better,’ without organizations setting up clinical trials from the start so that we could compare different devices, and without women giving properly informed consent that a different kind of device would be used,” Wollaston said.
Wollaston wants to move to a regulatory model that requires medical devices to be put through a clinical trial if they are “altered in any way.” Other politicians joined in, painting the different levels of oversight applied to drugs and devices as a “fundamental flaw” in how medical technologies are licensed.
The politicians participating in the debate voted to call on the government to suspend prolapse and incontinence mesh operations until the results of an audit are available. The politicians also want the National Institute for Health and Care Excellence to release its new guidelines on the use of mesh to treat forms of incontinence this year, not in 2019 as currently planned.
Debate Transcript
Denmark to Waive Fees for Phase I Trials to Attract More Clinical Research Programs
Denmark is to stop charging commercial sponsors fees to run Phase I drug trials. The change forms part of a wider effort to make Denmark a more attractive location to conduct clinical research.
Once the changes come into force on 1 July, commercial sponsors will no longer need to pay a fee when they apply to initiate or modify an early-phase clinical trial. The Danish Medicines Agency (DKMA) is also waiving annual fees. The change comes months after Denmark freed noncommercial sponsors from the fees.
Denmark took the actions after making the attraction of more clinical research one of five pillars of its life science strategy. The government and rival political parties have agreed to make money available to support the strategy and thereby grow the sector.
DKMA Notice, Political Agreement (both Danish)
Other News:
EMA and the Netherlands have finalized an agreement on how the agency and its employees will be treated by the Dutch government after they relocate to the country. The Seat Agreement is intended to ensure EMA “can function properly and independently in the Netherlands,” the agency said. The agreement is based on those between the Netherlands and other European agencies, such as law enforcement group Europol. Press Release
EMA has scheduled a meeting to discuss the development of checkpoint inhibitor-based combination therapies in pediatric populations. Meeting Agenda


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