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ICH guideline

ICH Q8/Q9/Q10: Implementation

ICH guideline · Quality Guidelines · Step 5

Key facts

ICH code Q8/Q9/Q10
Title Implementation
Guideline series Quality Guidelines
ICH step Step 5
ICH summary (excerpt) ICH Q9(R1) together with ICH Q8(R2) and ICH Q10 form a trio of ICH Quality Guidelines that encourage the further development of science- and risk-based approaches to quality.The Questions and Answers document developed by the Quality Implementation Working Group (IWG) is intended to facilitate the implementation of the…
File ICH Q8/Q9/Q10 Q&As (R2) Points to Consider
File type PDF
File on ich.org database.ich.org

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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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