ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Scientific guideline

This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.

For further information, please consult the ICH Q4B.

Keywords: Recognition pharmacopoeial tests, Q4B evaluation process

Current version

ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5

Adopted Reference Number: EMA/CHMP/ICH/222007/2006