ICH: Revised ICH Q1 Draft for Consultation

21.04.2025

News

ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C (quality of biotechological products) guidelines and provides additional guidance on principles relating to stability. It also introduces new topics, including advanced therapies, bracketing and matrixing, stability modeling, and guidance on reference standards and novel excipients.

The document has reached Step 2 of the ICH process and is now open for public consultation.

Sources:

ICH: ICH: Draft Q1Guideline Step 2

ICH: Presentation on ICH Q1

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EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

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