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Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
Pharmacopoeia Compliance Series
This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.
This article is part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, March 2020
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Monograph Development: Why and When to Participate," BioPharm International Regulatory Sourcebook eBook (March 2020).