Euro Roundup: Industry wants clarity on links between EHDS, existing legislation

RoundupsRoundups | 04 August 2022 |  By 

MedTech Europe is calling for clarity on aspects of the European Health Data Space (EHDS), including the interplay between the proposal and existing laws such as the new device and diagnostic regulations and the planned Artificial Intelligence Act.
The European Commission proposed creating the EHDS in May to facilitate better use of health data, including by making it easier and less costly for researchers to gain consent to use patient data. The draft plan grew out of a public consultation that found cross-stakeholder support for policies that make better use of health data.
In its comments on the consultation, MedTech Europe said “the EHDS is a pioneering initiative and has the potential to empower patients [and] accelerate the European Single Market for digital health and data by tackling barriers to cross-border data sharing.” While EHDS is “a tangible first step toward a European health data ecosystem,” the trade group noted some concerns and potential improvements.
the interplay of EHDS and other laws is a concern, the group wrote.  While EHDS is supposed to complement European Union laws, MedTech Europe sees “the risk of disproportionate over-regulation of the medical technology industry in complying not only with existing legislation but with several additional regulatory requirements arising from new legislation.”
“MedTech Europe also asks for more legal clarity on the interaction between existing legislation with new EHDS requirements, as the proposal appears to assume a possible demarcation between electronic health records systems, medical devices, and high-risk AI systems. Yet, the proposal does not consider the nature of medical technologies, which may have a modular design that may not allow an easy delineation of functions and modules,” the trade group wrote in its feedback.
MedTech Europe is “strongly” urging that EHDS gives special consideration “to the fact that medical technology manufacturers could be mandated to conduct conformity assessments under different regulations if a product or service were to qualify for different categories.”
The trade group’s response to the proposal also addresses the primary and secondary use of electronic health data, the protection of intellectual property rights and trade secrets, interoperability, governance, and implementing and delegated acts in the proposal.
Consultation Feedback
EMA publishes revised implementing rules, explanatory note for fees payable to agency
The European Medicines Agency (EMA) has published revised rules for the implementation of the fees payable regulation, increasing its rates across the board and revising some text on when the payments are required.
EMA previously set the fees in a document that took effect in January. The latest update, which sets the fees as of 1 August, increases the fees set in the older document. For example, the fee for the extension of marketing authorizations for medicinal products for human use has increased from €89,000 to €94,000. The Type II variation fee has risen by the same amount.
The agency has also revised the text on the situations in which companies need to pay the fee for canceling formally notified distinct inspections. EMA has added a new scenario in which the fee is payable, explaining it will request €11,800 when an inspection is canceled due to “the notification of the non-submission of the intended application by the prospect applicant, for cases where the inspection was requested on the basis of a “letter of intent to submit” (i.e. prior to the actual submission of an application for a marketing authorisation or rolling review).” EMA tweaked the wording of other points.
EMA published the revised rules alongside its explanatory note on general fees payable to the agency. The note discusses the reduced fee level for veterinary medicinal product variations requiring assessment.
Implementing Rules, Explanatory Note
Swissmedic updates guidance on authorization procedures for COVID medicinal products
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the procedures for authorizing COVID-19 medicinal products during the pandemic. Swissmedic has added a new section on the activity of active ingredients against new SARS-CoV-2 variants.
In the new section, Swissmedic clarifies what information it needs once the World Health Organization (WHO) classifies a SARS-CoV-2 variant as a variant of interest, variant of concern or lineage under monitoring. The section explains that marketing authorization holders (MAH) must continuously monitor the efficacy of medicinal products used to prevent or treat COVID-19 against current SARS-CoV-2 variants.
By the time the WHO defines a variant as a variant of interest, variant of concern or lineage under monitoring, the MAH must file a submission plan on meeting the conditions via the Swissmedic Portal. The plan should include a schedule showing when the results of the tests to determine activity against certain variants will be submitted.
Swissmedic expects MAHs to include an evaluation of the study findings and their impact on the benefit-risk profile in Module 2. The MAH “is obligated to submit the required documentation together with updated medicinal product information as soon as relevant data on new SARS-CoV-2 variants are available.”
MAHs are supposed to tell Swissmedic the exact submission date in advance so the agency can promptly perform its formal check. “Depending on the classification of the safety relevance, the deadlines may be shortened appropriately to ensure rapid inclusion in the medicinal product information,” Swissmedic wrote.
Swissmedic Notice
EMA reexamines recommendation to withdraw obesity drugs after industry request
EMA has reopened its assessment of the risks and benefits of amfepramone medicines at the request of marketing authorization holders. The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the withdrawal of the marketing authorizations in June.
PRAC’s recommendation followed a review in which it found measures to restrict the use of the obesity medicines for safety reasons had failed to have the desired effects, with patients continuing to take them for longer than three months and thereby potentially raising the risk of serious side effects such as pulmonary atrial hypertension.
While PRAC considered introducing further measures to minimize the risks, it was unable to identify actions that would be sufficiently effective, leading it to recommend amfepramone medicines should no longer be available in the EU. The conclusion triggered a response from MAHs, which have succeeded in getting EMA to reexamine the recommendation.
EMA Notice
European Pharmacopoeia Commission forms working party on mRNA vaccine quality
The European Pharmacopoeia (Ph. Eur.) Commission is forming a working party to elaborate quality standards for mRNA vaccines for inclusion in Ph. Eur.
The newly formed group, the mRNAVAC Working Party, will initially focus on the development of a consolidated strategy for future standards addressing mRNA vaccines and their components. A recent European Directorate for the Quality of Medicines (EDQM) Symposium on Nanomedicines will inform the work.
The Commission is seeking invitations from specialists with experience in the formulation of mRNA vaccines and the analytical procedures used in the quality control of the products and their components. Applicants could come from licensing authorities, official medicines control laboratories, industry or academia.
EDQM Notice


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