ICH guideline

ICH Q4A: Pharmacopoeial Harmonisation

ICH guideline · Quality Guidelines

Key facts

ICH code Q4A
Title Pharmacopoeial Harmonisation
Guideline series Quality Guidelines
ICH summary (excerpt) The pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group (PDG), have been closely involved with the work of ICH since the outset and harmonisation between the major pharmacopoeias, which started before ICH, has proceeded in parallel.

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About ICH guidelines

ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

Source: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline summaries are ICH material, reproduced with acknowledgement

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