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Medicines or dietary supplements? Comparative analysis of regulatory requirements for the registration of herbal products
- Authors: Safonova N.V.1, Trofimova E.O.2
- Affiliations:
- Sotex PharmFirm, Moscow, Russia
- Saint-Petersburg State Chemical Pharmaceutical University, Saint Petersburg, Russia
- Issue: No 2 (2023)
- Pages: 165-171
- Section: Articles
- URL: https://remedium-journal.ru/journal/article/view/1617
- DOI: https://doi.org/10.32687/1561-5936-2023-27-2-165-171
- Cite item
Abstract
Introduction. Herbal products represented at the market in the form of herbal medicinal products (HMP) and herbal dietary supplements (HDS) largely differ in the level marketing authorization requirements. In this regard, it is actual to study the issue of how legislative requirements affect the choice of alternatives in terms of registration of products to be launched. The purpose of the study was to conduct a comparative analysis of the registration requirements for HMP and HDS in accordance with the law of the Eurasian Economic Union (EAEU) and to assess the activity in the field of herbal products launches. Materials and Methods. The study was based on the marketing authorization legislation for HMP and HDS, as well as official information on registered products. Results. Transition to the EAEU legislation has led to a significant complication of the requirements for the HMP marketing authorization, while this has not happened for HDS. As well as in the period of validity of the national requirements on the Russian pharmaceutical market, the number of registered HDS is an order of magnitude higher than the HMP. In 2021-2022 136 registration certificates for HMP and about 2 thousand certificates for HDS were issued. The registration of 69 HMPs was canceled due to the need to bring the registration dossiers in line with the new requirements. Conclusion. The regulatory model created in accordance with the EAEU law, with a general increase in the quality and safety requirements for HMP and HDS, at the same time does not create the necessary incentives for registering herbal products as HMP. This problem solution is seeing, among other things, in the expansion of opportunities for using simplified procedures for registering PRPs.
About the authors
Natalia V. Safonova
Sotex PharmFirm, Moscow, Russia
Email: 001
Elena O. Trofimova
Saint-Petersburg State Chemical Pharmaceutical University, Saint Petersburg, Russia
Email: 002
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