Euro Roundup: European Commission calls for EMA to urgently advance Biotech Act preparations
The European Commission has set out the need for the European Medicines Agency (EMA) to urgently advance preparations for the Biotech Act.
EMA’s management board discussed the Commission’s position at a recent meeting. Board members voiced support for the Commission’s call for urgent action, reflecting a Biotech Act timeframe that they called “ambitious.” The legislative procedure states the first changes to the clinical trials regulation triggered by the Biotech Act could come into force in early 2028.
The Biotech Act proposal, which the Commission adopted in December 2025, affects the Clinical Trials Information System (CTIS). Changes to the authorization and supervision of clinical trials proposed in the Biotech Act impact about 70% of the current CTIS functionality, the board said.
Through the legislation, the Commission wants to accelerate clinical trial assessments, provide greater flexibility for major modifications, strengthen collaboration between Member States, support risk-based authorization, and simplify the assessment of combined studies involving medicines, medical devices, and in vitro diagnostics.
The expectation is that CTIS will support key Biotech Act initiatives “as soon as possible, following the adoption of the legislation,” the board said. Based on that expectation, the board emphasized “the importance of delivering key CTIS functionalities, including accelerated assessment timelines, as early as possible and in time for the adoption of the Biotech Act.”
Immediate investment in the CTIS platform is needed to implement the changes, the board said. Work on “a new modern CTIS platform” that delivers all the clinical trials functionality foreseen by the Biotech Act is set to start early next year. EMA will present a detailed roadmap, including resource impact, for the delivery of new CTIS functionalities to its board in December.
The board also used the meeting to discuss preparations for implementing the new EU pharmaceutical legislation. EMA has done “significant work ... in many areas,” the board heard. The agency is prioritizing initiatives that are earmarked for early entry into force, such as transferable exclusivity vouchers for priority antibiotics, the regulatory sandbox, and the management of shortages.
Swissmedic changes requirements for API establishment licenses and GMP certificates
The Swiss Agency for Therapeutic Products (Swissmedic) is changing its requirements for drug substance establishment licenses and good manufacturing practice (GMP) certificates.
Starting 15 November, prior registration of active substances in EMA’s Substance Management Services (SMS) database will become a mandatory requirement for their inclusion in Swissmedic establishment licenses and GMP certificates. The removal of Swissmedic’s ability to issue licenses and certificates without prior registration applies to both hardcopy and electronic versions.
The new mandatory requirement will affect applications for first establishment licenses and responses to filings for a change to an existing licence or following an inspection. It is essential that all active substances listed in establishment licenses and GMP certificates are registered in the SMS database, Swissmedic said.
Swissmedic has asked active substance manufacturers to ensure their ingredients are correctly registered in the SMS database. Manufacturers should include a list of their active substances as registered in the SMS database when applying to receive or change a license.
Organizations should email Swissmedic if they have “a pending application for an establishment licence for the manufacture of active substances and the active substances in question have to be referenced in the establishment licence or the organization has just been inspected.” Otherwise, manufacturers can send hard-copy letters to Swissmedic.
Changes to the EudraGMDP database triggered the new requirements.
European Commission chooses first two medical devices for joint clinical assessment
The European Commission has selected products from Edwards Lifesciences and Highlife as the first medical devices to undergo joint clinical assessment (JCA).
Under the Health Technology Assessment Regulation, European bodies jointly assess medicinal products and some medical devices to inform national coverage decisions. The EU has published four JCA reports for medicinal products and has 15 ongoing assessments. The JCA program is now expanding to medical devices.
The first two devices selected for JCAs are both mitral valve replacement systems, a class of product used to treat damaged or diseased heart valves. The Dutch National Health Care Institute will assess Edwards’ Sapien M3 system with support from the Norwegian Medical Products Agency. The French National Authority for Health is taking the lead on the Highlife device, assisted by its Polish counterpart.
Edwards received a CE mark for Sapien M3 in April 2025. Highlife disclosed its CE mark in January. While CE marks support commercial use, uptake of products depends on coverage by payers. The JCA process will generate assessments of the clinical benefits of the devices to inform payer decisions.
The Commission plans to select medical devices for JCAs each quarter. Class IIb and class III devices that have been evaluated by an expert panel are eligible for JCAs. The program is also open to class D in vitro diagnostics that have been through the expert panel process.
Swissmedic implements updated biosimilar guidance in light of EMA reflection paper
Swissmedic has implemented updated biosimilar guidance to bring its position in line with a recent EMA reflection paper.
EMA’s reflection paper set out a “tailored” approach to developing biosimilars. Leveraging its experience with biosimilars, EMA said developers will generally no longer need to run comparative efficacy studies. In the past, such studies have typically not added pivotal information for assessing biosimilarity, EMA said. The paper led Swissmedic to reconsider its own position.
“Comparative efficacy studies are now no longer always required for well-characterized biological active substances if the analytical comparability assessment in combination with pharmacokinetic and appropriate safety studies enable more sensitive demonstration of sufficient similarity,” Swissmedic said.
Swissmedic framed its rethink as a response to “progress in the analytical sciences and the comprehensive regulatory experience gained.” The agency also updated the process for extrapolating indications from the reference product to the biosimilar.
The revised guidance took effect on 1 October.
Other News:
The Committee on the Environment, Climate and Food Safety has published its opinion on the Biotech Act. The Parliament committee proposed limiting the exemption from environmental risk assessment for certain advanced therapy medicinal products containing genetically modified organisms. The exemption would apply to products with “no or negligible risk to human health.” Committee Opinion
