Procedure for the Development of Monographs and Other Texts for The International Pharmacopoeia. WHO Technical Report Series, No. 992, 2015, Annex 1
(2015; 4 pages)


The process described below is designed to ensure wide consultation and transparency during monograph development and that the adopted texts are made available in a timely manner.

Subject to the availability of the necessary resources, the Secretariat aims to publish adopted monographs or general texts for inclusion in The International Pharmacopoeia after every meeting of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations. The proposed changes to the process for the development of monographs reflect this new approach.

Monographs in The International Pharmacopoeia provide an important element of the quality dimension for the medicines (included on the basis of their efficacy and safety) in the WHO model lists of essential medicines and in WHO treatment guidelines.

Major WHO programmes such as the Prequalification Team – Medicines (funded by the Bill & Melinda Gates Foundation and UNITAID) and others funded or managed by partner organizations such as the United Nations Children’s Fund and the Global Fund to Fight AIDS, Tuberculosis and Malaria, rely heavily upon the quality specifications set out in The International Pharmacopoeia.

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