Draft revision to ICH Q1 on Stability

Date

April 11, 2025

Category

EU Regulations

Description

An expert working group (EWG) to revise the current ICH stability guidelines, Q1A-F and Q5C, was established in November 2022. The objectives of this EWG were to:

1. Streamline the series by combining the various guidelines into a single guideline focused on core stability principles
2. Promote harmonised interpretation by addressing potential gaps and areas of ambiguity,
3. Address additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of modern science and risk-based principles
4. Expand the recommendations for stability studies to incorporate climatic zones not included in current Q1/Q5C guidelines
5. Align with ICH's Quality Vision, including new topics such as stability considerations for advanced therapies and vaccines

The draft revision reached step 2b of the ICH process on 11 April 2025, see Q1 EWG at  ICH Official web site : ICH and will subsequently be issued as a step 3 draft for public consultation in all ICH member countries and regions.