EU Regulatory Roundup: Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials

RoundupsRoundups | 21 February 2019 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has warned that it could suspend 1,300 clinical trials in the event of a no-deal Brexit. The warning reflects the fact that the sponsors of many studies are still registered in the UK and there are stipulations in the Medicinal Products Act (AMG) about who can run trials in Germany.
The AMG prohibits the conduct of clinical trials in Germany by organizations based outside the EU or another country subject to the agreement on the European Economic Area. If the UK leaves the EU without a deal next month, sponsors based in the UK will no longer meet those criteria. Under AMG, BfArM will then be legally obligated to order the suspension of clinical trials sponsored by the UK-based organizations.
A lot of clinical trials may suffer this fate. Last month, BfArM’s review of a database of studies found around 1,300 clinical trials sponsored by organizations registered in the UK. If these organizations are still registered in the UK at the time of a no-deal Brexit, BfArM will stop their studies and prohibit the subsequent recommencement of the programs.
BfArM wants to avoid that outcome, but is concerned that time is running out for sponsors to make the necessary changes. It takes BfArM 20 to 35 days to process changes to the location of a clinical trial sponsor. At the time of writing, there are 36 days until Brexit and little evidence that the UK can resolve the political logjam that is preventing it from signing off on a deal that would save it from a hard split from the EU.
As such, BfArM wants sponsors to contact it immediately with their amendments. Sponsors that fail to do so by late February will receive messages from BfArM asking them to comment on their situations.
BfArM has asked sponsors not to submit the location change requests as part of submissions that feature other amendments to ensure the filings are processed as quickly as possible.
If a filing only covers a change in sponsor location, BfArM will allow applicants to amend multiple clinical trials in a single submission without filling in a substantial amendment notification form. German officials want applicants that take advantage of this option to include a table listing the BfArM submission number and the EudraCT number, as well as a cover letter with the reference line of "Brexit-related change in sponsor/legal representative.”
This bulk-amendment option is not available to companies that need to change the importer or manufacturer responsible for final batch release. BfArM requires companies to use individual notifications to request these changes, as they necessitate the review of the manufacturing chain.
BfArM Notice
EMA’s PRAC Calls for Suspension of Fenspiride Medicines Amid Heart Rhythm Fears
The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended suspending fenspiride medicines. PRAC called for the EU-wide suspension of the cough medicines to protect patients while it reviews evidence of their effect on heart rhythm.
Fenspiride medicines manufactured by companies including Servier are approved for use in seven EU member states under national authorization procedures. The drugs are used to treat coughs caused by lung diseases but have been dogged by reports linking them to heart rhythm problems. While the number of case studies documenting the link is limited, France, one of the countries in which the drugs are sold, was concerned enough to request an EU-level review of the evidence.
The European Medicines Agency’s (EMA) PRAC has initiated the review and taken a precautionary action to protect patients in the meantime. As the mooted side effects of fenspiride are serious and the drug is only used for symptomatic treatment, PRAC wants healthcare professionals to stop giving it to to patients while the review is ongoing.
PRAC’s caution is underpinned by limited case reports on the effect of fenspiride on cardiac rhythm and nonclinical evidence that the drug increases QT intervals. The action came days after the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) suspended the marketing authorization of a fenspiride product, Pneumorel, sold by Servier in France.
To aid its review, PRAC is asking people to provide it with information on the link between fenspiride and QT prolongation and cardiac arrhythmia. PRAC is accepting feedback until 11 March.
EMA Notice
UK Politicians Float Prospect of Strengthening Medical Device Rules After Brexit
A government health minister has said the UK could strengthen its regulation of medical devices after leaving the EU. The minister called the incoming EU regulations a “baseline” that the UK could build on if it gains the ability to set its own rules after Brexit.
Politicians in the UK have become increasingly critical of how medical devices are regulated following the vaginal mesh scandal and other events, with one member of Parliament calling the industry the “wild west” in a debate last year.
The UK’s intention to adopt incoming EU device rules despite Brexit means regulation of the market will change in the coming years. However, Jackie Doyle-Price, a government health minister, sees the EU standards as just “a strong and improved baseline,” not necessarily the complete, final set of rules for the post-Brexit UK.
“As we depart from the European Union, we have an opportunity to alter our regulatory system. I am not sure that all my Conservative colleagues, in pushing Brexit, see it as an opportunity to tighten regulation, but that opportunity remains,” Doyle-Price said in a debate in the House of Commons.
Doyle-Price’s comment about her Conservative colleagues refers to the fact that some of the people pushing for Brexit want to leave the EU to enable the UK to adopt lighter regulations. The medical device proposal runs counter to those intentions, but could win favor from other politicians who have been highly critical of how the industry is regulated.
The future of medical device regulation in the UK will be shaped by the Cumberlege review, which is due to report its findings later this year, but it is already clear any calls for tighter regulation will find a receptive audience in parts of Parliament. Doyle-Price, for example, said regulations have perhaps “focused excessively on what is in the commercial interests of businesses.” The health minister would rather regulations focused on patient safety. 
Debate Transcript
France Expands Use of Clinical Trial Fast Tracks to Slash Approval Times
France’s ANSM has opened up its clinical trial fast tracks to developers of cell and gene therapies. The processes will cut the time it takes for developers of advanced therapy medicinal products (ATMPs) to get green lights to start studies.
ANSM introduced its clinical trial fast tracks in October and outlined plans to expand them to cover ATMPs shortly thereafter. Now, ANSM has followed through on its proposal.
Developers of unapproved ATMPs can use one fast track to cut approval times from 180 days to 110 days. A second fast track for further development of approved ATMPs will process applications within 60 days.
The review times are longer than for trials of other types of drugs that board the fast track, which can be approved within 25 days, but represent improvements over the historical ATMP timelines.
ANSM Notice (French)


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