This topic was endorsed by the ICH Assembly in June 2021.

Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:

• Streamlining the series, combining the various guidelines into a single guideline focused on core stability principles;
• Promoting harmonised interpretation by addressing potential gaps and areas of ambiguity; addressing additional technical issues, including relevant stability strategies and innovative tools that strengthen the application of risk management;
• Considering inclusion of new topics, such as stability considerations for advanced therapies.

The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles, addressing drug product types including substances, intermediates, and devices.

Further information can be found in the Q1/Q5C Concept Paper and Business Plan.