Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Swissmedic Sees Surge in Inquiries as Safety Scares, Brexit Fuel Questions
The Swiss Agency for Therapeutic Products (Swissmedic) has seen a surge in the number of inquiries from the public and specialists. Swissmedic attributed the trend to concerns about quality problems such as the valsartan scandal and uncertainty about the consequences of Brexit.
In 2018, Swissmedic issued 8,381 responses to inquiries, an increase of 18% over the previous year. The increase was driven by an uptick in all types of requests. General inquiries from specialists and the public increased by 8% and 32%, respectively. Over the same period, inquiries about medical devices rose 26%.
Specialists accounted for around two-thirds of general inquiries and 85% of inquiries related to medical devices, but the increased activity seen last year was due to greater interest from both them and the general public.
That is reflected in the topics Swissmedic identified as drivers of the increased activity. The drivers include both niche topics of interest to specialists, such as the incoming European Union regulations on medical devices and in vitro
diagnostics, and broader subjects including the valsartan quality scare and the Implant Files reports that raised concerns about the regulation of medical technologies. The uncertainty about the consequences of Brexit drove requests for information, too.
Despite the surge in activity, Swissmedic responded to 99% of inquiries within 10 days, beating its 95% target.
Swissmedic shared the figures in its annual report for 2018. The increased interest in Swissmedic evident in the inquiry data was reflected in other parts of the report, including a section on traffic to the agency’s website. In 2018, the Swissmedic website received 884,715 unique visitors, an increase of 68% over the previous year. Freedom of information requests more than doubled, too.
EMA Opens Early Engagement Channel to Developers of Antimicrobials
The European Medicines Agency (EMA) has opened an early engagement channel to developers of drugs and vaccines against bacterial and fungal infections. EMA took the step to try to strengthen the pipeline of developmental candidates designed to combat antimicrobials resistance.
EMA has an established forum for early engagement through its Innovation Task Force (ITF), but in the past it reserved this channel of communication for developers of innovative medicines. The restrictions reflected the additional challenges and uncertainties involved in the early research and development of innovative emerging therapies, methods and technologies, plus the potential for EMA input to ease some of these problems and speed the advance of important products.
Now, EMA has decided that the antimicrobial sector would benefit from extra support. Leveraging the ITF, EMA is opening itself up to all developers of medicines used in the treatment or prevention of life-threatening or debilitating microbial infections. EMA wants to engage in early talks with these companies in the belief the discussions may strengthen the pipeline of new antimicrobials.
Specifically, EMA envisions the dialogue helping the planning of drug developers and later use of other regulatory tools, such as the scientific advice program. The ITF service is free.
The expansion of the program follows a European Parliament resolution that called for development of antimicrobial medicines to be prioritized and accelerated. EMA framed its action as being in line with the Parliament resolution, although given the difficulty of discovering new antimicrobials and the uncertain commercial prospects for such drugs, there are limits to what the agency can achieve.
MHRA Testing Portal to Mitigate Problems Accessing Clinical Trial Documents
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has discussed its efforts to counter barriers to the access of clinical trial documents. MHRA is testing the use of its own portal as a way to access documents it needs to perform inspections.
Regulators including MHRA have encountered new problems as clinical trial sponsors and study sites have moved from paper to electronic documents. MHRA outlined the problems at a recent event.
“Issues are increasingly seen on inspection where SOPs and training records are held in an internal system to which the inspector is not provided direct access, as the need for access to inspectors had not been considered as part of the user requirements for the system,” a MHRA representative said in response to a question at the agency’s stakeholder engagement meeting earlier this month.
The MHRA representative also discussed the “increasing difficulty” of accessing trial documents in advance of inspections and during site visits. These issues are hindering MHRA’s ability to properly assess the compliance of clinical trials with regulations.
To remedy the problem, MHRA is testing the use of its own portal for the provision of electronic documents. In theory, the portal could provide sponsors with a secure way to share electronic clinical trial documents. MHRA discussed the tests of the portal in the context of office-based inspections, which it is using in multiple areas in an attempt to make better use of its resources.
MHRA addressed multiple other topics at the stakeholder engagement meeting, including its approach to artificial intelligence. Asked about how it will regulate AI systems, which may evolve continuously before and after coming to market, MHRA said it is setting up a cross-functional group to assess the technology and its response to it.
Swissmedic Updates Biosimilar Guide to Address use of Foreign Comparators
Swissmedic has updated its guidance on the authorization of biosimilars. The changes expand on points including the use of foreign comparators in the assessment of biosimilars destined for the Swiss market.
Version 1.0 of the guide only came into force at the start of the year, but Swissmedic has already identified several ways to improve the text. The new version came into force this week.
In revising the guidance, Swissmedic has provided additional information about the use of biosimilar comparators sourced from outside Switzerland. Swissmedic prefers companies to use comparator products from Switzerland, but will accept the use of drugs from the EU or the United States, provided the biosimilar developer performs some additional steps.
Swissmedic wants companies that use overseas comparators to show the product is a suitable stand in for a Swiss-sourced medicine. Specifically, Swissmedic wants the strength, route of administration and other details of the comparator to be identical to the product sold in Switzerland. Swissmedic also wants companies to share a comparison with the corresponding clinical trials for the comparator product.
The new advice on comparator products is among the more substantial changes to the guidance. Other revisions include a clarification that procedures involving drug master files are not applicable to biological active substances.
’s Committee for Medicinal Products for Veterinary Use
(CVMP) has re-elected Ireland’s David Murphy
as its chair. Murphy will serve another three-year term. CVMP disclosed the re-election at a meeting that also featured consensus positive opinions on initial marketing authorizations for Evicto and Nasym, respectively a generic flea treatment and vaccine for use in cattle. CVMP Notice
’s National Agency for Medicines and Health Products Safety
(ANSM) has alerted healthcare professionals to a modification to Abbott
’s FreeStyle Libre
blood glucose monitor. The change affects an internal component and is unrelated to the adhesive that comes into contact with the skin. Around 0.2% of French users of the device experience a skin reaction. ANSM Notice