26 May 2025
Swissmedic: Meeting of the ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in Madrid on 13 and 14 May 2025. Guidelines in four new areas of harmonisation were adopted, the starting timeframe for which will be determined in a later step.
Areas of harmonisation include the use of real-world evidence (RWE), the utility of comparative efficacy studies (CES), rare disease drug development and regulatory challenges of Advanced Therapy Medicinal Products (ATMPs).
For more information, see here.
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