Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Dutch MEB Looks to Spread EMA Workload to Offset Loss of MHRA After Brexit
Dutch regulators are hoping to spread European Medicines Agency (EMA) work currently handled by the United Kingdom across multiple agencies after Brexit. The Dutch Medicines Evaluation Board’s (MEB) goal is to involve more member states in EMA’s activities, rather than significantly increase its own capacity.
EMA currently relies heavily on the Medicines and Healthcare products Regulatory Agency (MHRA) but looks set to lose access to this capacity when the UK leaves the European Union. MEB increased its capacity last year using temporary financial support from the Dutch government in anticipation of its workload growing. However, rather than grow to take on all of MHRA’s work, MEB wants to equip other member states to shoulder some of the burden.
“We do not necessarily have to grow. In the long term, fewer procedures will be carried out by large agencies, but more by a number of countries together,” Hugo Hurts, executive director at MEB, said in the agency’s annual report.
Hiring drives by regulatory agencies in Denmark, Spain and other countries mean EMA should have a broader pool of talent to draw on after Brexit than in the past. MEB is working to further enhance the pool by helping agencies from smaller countries that joined the EU more recently to build up their regulatory capacity. Interest in the program has exceeded expectations, with 10 member states, not the anticipated five, signing up to receive MEB’s support.
MEB hopes these agencies will take on some of the work currently handled by MHRA but, even so, it expects its relationship to EMA to change after Brexit. Today, MHRA performs many procedures that are “less interesting from a scientific perspective” and therefore less sought after by member states, Hurts said. Hurts expects MEB to handle these tasks after Brexit.
The agency’s proximity to EMA’s new headquarters will make it the obvious pick for other tasks, too.
“It could also be the case that if they need a chair for a new working group that they simply call the MEB. The Dutch experts are within reach for the EMA. I consider it very likely that we will be a lot busier at the MEB,” Hurts said.
EMA Makes Major Update to EudraVigilance Launch Q&A Document
EMA has added 150 new entries to its question and answer document on the introduction of the EudraVigilance system. The big update addresses very specific issues stakeholders have encountered since the drug safety monitoring system went live late last year.
While the new questions span most of the sections covered by the document, they cluster around certain topics. The section on the use of the EudraVigilance Medicinal Product Dictionary data-entry tool (EVWEB) and individual case safety report (ICSR) download manager accounts for more than half of the new entries, reflecting the fact companies have just started using these services.
The questions handled in the update show the specific uncertainties and problems users are running into as they start to use the system. In the responses, EMA addresses problems users have found when using the ICSR download tool in Internet Explorer, the interaction between EudraVigilance and German law and plans to have the system send ICSR information to marketing authorization holders (MAHs), rather than make them download the reports manually.
Stakeholders also had lots of questions about EMA’s good pharmacovigilance practice guideline on the management and reporting of adverse reactions. Several of the questions deal with how the EMA guidelines relate to national systems, such as the French imputability method and Italy’s national pharmacovigilance database.
EMA is yet to provide full answers to some of the questions. Asked about potential compliance issues MAHs should be cognizant of, EMA said it will soon publish a clarification on the processing of ICSRs MAHs download from EudraVigilance.
Commission Warns MAHs Against Taking a ‘Wait and See’ Approach to Brexit Preparations
The European Commission has advised MAHs to abandon their “wait and see” approaches to Brexit and act as if the UK will split decisively from the EU in 12 months time. Officials fear complacency will lead to supply disruptions if attempts to either soften or defer Brexit collapse.
EMA has consistently advised MAHs to prepare for the UK to be treated as a third country from the end of March 2019 onward. That creates a relatively near-term deadline for MAHs to relocate their activities and regulatory records from the UK to other member states. However, amid uncertainty about the timing and nature of Brexit, some MAHs have opted to delay committing time and money to preparations.
“Many MAHs have not yet taken the necessary regulatory actions, [such as] marketing authorizations transfers, relocation of QPPV etc. While recognising the complexity of some of these procedures for companies to put in motion, there seems to be also a ‘wait and see’ approach by the MAHs,” the Commission wrote in its summary of a recent technical expert seminar.
The seminar took place before Brexit negotiators reached agreements on some key sections of the withdrawal document. Those breakthroughs increased the likelihood that the EU and UK will agree to a transition period that pushes the effective date of departure out to the end of 2020. The progress could encourage more companies to defer contingency planning in a belief that little will change for at least 20 months. However, the UK could still crash out of the EU with no deal in March 2019.
Officials plan to step up communication with MAHs to encourage them to act now. In other areas, the Commission is content with the state of Brexit preparations. The seminar summary highlighted the investments national regulators are making to equip themselves to handle work now performed by MHRA, calling the commitments “valuable and essential.”
The Commission plans to hold another technical seminar in the second quarter.
Danish Medicines Agency Issues Three Guidelines on Reimbursement
The Danish Medicines Agency (DKMA) has issued three guidelines on reimbursement. The texts cover different aspects of the reimbursement process, from making initial applications to performing health economic analyses.
One of the guidelines addresses filings for general reimbursement or conditional reimbursement. That is a topic DKMA has addressed before, but the new version brings its advice in line with current practices. DKMA also used the update to encourage applicants to include indirect comparisons when there is a lack of directly comparable clinical studies.
The other two documents are guidelines on periodic reassessments of reimbursement status and health economic analyses. The periodic reassessment text replaces two existing guidelines that were out of date. Similarly, the health economic guideline replaces a text published in 1998, bringing DKMA’s advice up to date with current national and international health economic practice.
has started as executive director of the Swiss Agency for Therapeutic Products
(Swissmedic). Bruhin was named as executive director late last year, but only took up the post this week. The arrival of Bruhin completes the revamp of Swissmedic’s management team that began in January when Stéphane Rossini
replaced Christine Beerli
as chair of the Agency Council. Swissmedic Notice
European regulatory agencies have issued warnings about T34 ambulatory syringe pumps. MHRA Notice
, HPRA Alert