12 May 2025
Swissmedic: Public consultation for ICH Guideline Q1 “Stability Testing of Drug Substances and Drug Products” launched
Swissmedic has launched the public consultation on Guideline Q1 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines). Stakeholders in Switzerland have the opportunity to comment on the draft “Stability Testing of Drug Substances and Drug Products” until 31 July 2025.
The updated guideline addresses specific topics that go beyond the core stability recommendations and principles. The aim is to promote a harmonised interpretation by addressing potential gaps and areas of ambiguity, as well as technical issues relating to stability strategies, innovative tools for the application of risk management and stability considerations for advanced therapies.
For more information, see here.
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