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EMA and ICH release two new Step 2b guidelines on drug development

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Published on: 22 April 2025

Published by LNB News

LNB News 22/04/2025

Document Information

Issue Date: 22 April 2025

Published Date: 22 April 2025

Jurisdiction(s): European Union

Article summary

The European Medicines Agency (EMA) and International Council for Harmonisation (ICH) have published two new Step 2b guidelines in April 2025. The ICH M15 guideline, published on 16 April, establishes a harmonised framework for evaluating model-informed drug development evidence, while the ICH Q1 guideline on stability testing of drug substances and products was released on 11 April. Both guidelines aim to standardise pharmaceutical development processes across jurisdictions. The M15 guideline follows a consultation period that concluded on 28 February 2025, while the Q1 guideline has now entered its public consultation phase.

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