TRS 1025 - Annex 1: Procedure for the elaboration, revision and omission of monographs and other texts for The International Pharmacopoeia
WHO Technical Report Series, no. 1025
20 April 2020
| Publication
Overview
Monographs in The International Pharmacopoeia (1) are essential standards to ensure the quality of medicines, thus contributing to their safe and efficacious use. They are developed and maintained in an open and transparent process, in line with the principles outlined in Good pharmacopoeial practices (2), and aim to foster harmonization and convergence of compendial quality standards to ultimately increase access to affordable, quality-assured medicines.
The procedure described next outlines the life-cycle of texts in The International Pharmacopoeia: how they are developed, revised and, if appropriate, finally omitted from the compendium. The text also includes steps related to the establishment of the International Chemical Reference Substances (ICRS) referred to in analytical tests.
WHO Team
Technical Standards and Specifications (TSS)
Number of pages
6
Copyright
CC BY-NC-SA 3.0 IGO