To the webinar series (in German): New ICH Q1 Guideline on Pharmaceutical Stability Testing
On April 24, 2025, the Committee for Medicinal Products for Human Use (CHMP) of the EMA published the draft of a completely revised ICH Q1 Guideline on stability testing of drug substances and drug products for public consultation.
Once finalized, the new guideline will replace the existing ICH Guidelines Q1A–F as well as Q5C. Its aim is to establish a comprehensive, cross-regional harmonization of stability study requirements aligned with current scientific and regulatory expectations.
Further information on the new ICH Q1 Guideline (in German)
The draft contains updated guidance covering all aspects of stability testing for synthetic and biological drug substances and drug products, including advanced therapy medicinal products (ATMPs). For the first time, the stability of novel excipients and adjuvants is also addressed. Of particular note are risk-based approaches to the development of stability strategies, which are intended to apply across the entire product lifecycle.
Following finalization, the new guideline will come into effect after a six-month transition period. Early engagement with the revised and expanded requirements is therefore essential.
Our six-part webinar series offers a structured overview of the new ICH Q1 Guideline and other relevant regulatory developments concerning stability studies in Europe.