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EMA Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
Post-authorisation changes are an inevitable part of medicinal product lifecycle management, and stability data play a critical role in demonstrating that such changes do not compromise product quality, safety, or efficacy. To harmonise expectations across the EU, the European Medicines Agency has issued Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorisation . Adopted in December 2025 and effective from January 2026, this

Sharan Murugan
Dec 132 min read
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ICH & USFDA Draft Guidance: Q1 Stability Testing: The Gold Standard for Drug Shelf Life and Quality
The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...

Sharan Murugan
Jun 233 min read
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ICH Guidance Q1: Stability Testing of Drug Substances and Drug Products (Step 2 Draft 2025)- Public Consultation
The International Council for Harmonisation (ICH) has released a significant update to its stability testing guidelines, consolidating...

Sharan Murugan
Apr 182 min read
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SFDA: Guidelines for Stability Testing of API and Finished Pharmaceutical Products
On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...

Sharan Murugan
Aug 25, 20221 min read
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