Harmonising nomenclature in pharmacopeial texts

[Display omitted] Nomenclature has always been a source of debate in the scientific literature. In the context of pharmaceutical regulation, varying interpretations of technical language can emerge due to philosophical or linguistic differences between two expert groups, which may undo efforts to ha...

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Bibliographic Details
Published in:European journal of pharmaceutics and biopharmaceutics 2023-07, Vol.188, p.227-230
Main Author: Kavanagh, Oisín N.
Format: Article
Language:English
Subjects:
Drug Industry
Harmonisation
Japan
Nomenclature
Pharmacopeia
Regulatory affairs
Regulatory science
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Summary:[Display omitted] Nomenclature has always been a source of debate in the scientific literature. In the context of pharmaceutical regulation, varying interpretations of technical language can emerge due to philosophical or linguistic differences between two expert groups, which may undo efforts to harmonise regulatory approval mechanisms for new medicines. This letter describes three examples of divergence within pharmacopeial texts produced in the US, EU and Japan and suggests how these have emerged. Ultimately, I advocate for a consensus and an all agreed upon terminology that would be helpful for the global pharmaceutical industry, as opposed to many agreements between individual manufacturers and regulators of medicines, which may reintroduce variation in regulatory standards.
ISSN:0939-6411
1873-3441
DOI:10.1016/j.ejpb.2023.05.018