On 11 April 2025, the ICH Q1 Draft Guideline “Stability Testing of Drug Substances and Drug Products” was published and is now open for public comment. Comments are possible until the end of July 2025, with some exceptions specifically indicated on the ICH website.
This new version is intended to merge and replace all the pre-existing individual ICH guidelines (ICH Q1A-Q1F and ICH Q5C) on the topic of stabilities. It will apply to active substances and finished drug products and takes into account new scientific and risk-based approaches and technologies.
This guideline will therefore incorporate:
- Stability testing of new drug substances and drug products (ICH Q1A)
- Stability testing: photostability testing of new drug substances and products (ICH Q1B)
- Stability testing: requirements for new dosage forms (ICH Q1C)
- Bracketing and matrixing designs for stability testing of new drug substances and products (ICH Q1D)
- Evaluation for stability data (ICH Q1E)
- Stability data package for registration applications in Climatic Zones III and IV (ICH Q1F)
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