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Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH RegionsRegulatory Resource: Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
The tripartite harmonised ICH guideline was finalised (Step 4) on 1 November 2007.
This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favourable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry.