1 October 2026
European Medicines Agency: Highlights of the September 2026 Management Board meeting
At its September meeting, the Management Board of the European Medicines Agency (EMA) was informed about the preparations for implementing the new EU pharmaceutical legislation. Initiatives earmarked for early entry into force have been prioritised, such as transferable exclusivity vouchers for priority antibiotics, the regulatory sandbox, and the management of shortages.
The Board was also updated on the further development of the Clinical Trials Information System (CTIS) in view of the proposed Biotech Act. The proposal is currently under discussion in the Council and the European Parliament and affects around 70% of the current CTIS functionality. It provides, among other things, for faster clinical trial assessments, more proportionate, risk-based authorisation procedures, and a simplified assessment of combined studies involving medicines, medical devices, and in vitro diagnostics. First changes to the Clinical Trials Regulation could enter into force in early 2028. The required functionalities are to be delivered in a new CTIS platform, on which work will start in early 2027.
For more information, see here.
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