Procedure for the elaboration, revision and omission of monographs and other texts for The International Pharmacopoeia
1. Introduction:
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.
2. Elaboration of monographs:
The steps of the development procedure are listed next.
Step 1: Identify medicines for which pharmacopoeial monographs need to be developed or revised. Set up a biannual workplan prioritizing medicines that are included in the WHO Model List of Essential Medicines (EML) (3) (or are otherwise relevant for World Health Organization [WHO] health programmes), preferably not already described in pharmacopoeias. Determine whether or not monographs for the corresponding active pharmaceutical ingredients also need to be developed or revised. Confirm the workplan with all WHO parties concerned, including the Department of Essential Medicines and Health Products, specific disease programmes and the WHO Prequalification Team (PQT).
Step 2: Search for relevant information on the product in the public domain, including other pharmacopoeias.
Step 3: Share the workplan with other pharmacopoeias and identify ways of collaboration to reduce the workload of the monograph development and to promote converged or harmonized quality standards that are globally applicable and recognized.
Step 4: Contact manufacturers of WHO prequalified medicines and/or of medicines authorized by WHO-listed national regulatory systems with an appropriate maturity level,3 to request quality control specifications and samples of their products.
Step 5: Assign WHO Collaborating Centres, collaborating laboratories and/or specific experts, if appropriate, to participate in the establishment or revision of the monograph.
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WHO TRS (Technical Report Series) 1025, 2020 Annex 1:
