Stakeholders in Switzerland have the opportunity to comment on the draft of Guideline Q1 “Stability Testing of Drug Substances and Drug Products” until 30 July 2025.
Most regulatory authorities successfully implement the ICH Q1 series (Q1A-Q1E), ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) in the regulatory framework. However, experience gained with implementation since the time these guidelines were finalised shows there are uncertainties related to the interpretation of the individual guidelines and how they fit together. Furthermore, it is recognised that innovation in analytical testing, including approaches as described in ICH Q2 and ICH Q14, along with the development of control strategies (ICH Q8 and Q11), Quality Risk Management principles (ICH Q9) and lifecycle approaches (as addressed in ICH Q10 and ICH Q12), create additional uncertainty for industry and regulatory agencies regarding how these pieces contribute to the assessment of product stability.
Through reorganisation into a combined core guideline ICH Q1 with topic-specific annexes/appendices, the updated Q1 Guideline will address specific topics beyond the core stability recommendations and principles (e.g. intermediates, devices, enhanced modelling). The revision aims to promote harmonised interpretation by addressing potential gaps and areas of ambiguity, while also addressing technical issues around stability strategies, innovative tools for the application of risk management and stability considerations for advanced therapies.
Comments can be sent using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments, but no feedback on the individual comments. Once the public consultation phase has been completed, the comments submitted will be discussed in the responsible ICH working group and taken into account where appropriate.
Links to the guideline and feedback form can be found at: