Ведомости Научного центра экспертизы средств медицинского применения (Apr 2024)
Challenges Associated with Forming Generic Names for Herbal Medicinal Products
Abstract
INTRODUCTION. The lack of a unified approach to establishing generic (grouping) names, which must be specified for herbal medicinal products, presents a challenge to developers and manufacturers preparing registration dossiers, as well as to regulators reviewing their submissions.AIM. This study aimed to set forth common approaches to establishing generic names for herbal medicinal products based on studying the terminology used in different legal systems.DISCUSSION. The authors analysed the pharmaceutical terminology used for herbal medicinal products at national and supranational levels in the Russian Federation, the Eurasian Economic Union (EAEU), the Republic of Belarus, the European Union (EU), the United Kingdom, and the United States. This analysis revealed differences in the terminology used in the Russian Federation and the EAEU. For example, the definition of “herbal drugs” is more detailed in the EAEU documents than in the Russian documents, and the definitions of “herbal drug preparation” and “herbal medicinal product” are not the same as well. The authors analysed the approaches to generic naming of herbal medicinal products and detected some improperly formed generic names in the regulatory documentation and Russian State Register of Medicinal Products. In addition, the study revealed variability in generic names proposed by different manufacturers for medicinal products having the same trade name. The authors described the selection of generic names for herbal medicinal products, including fatty or essential oils and liquid or dry extracts. The authors touched upon generic naming of some types of source plants when the morphological group of the herbal drug or the name of the source plant is ambiguous, the Latin name and the Russian name of the herbal drug are inconsistent, or the Latin name of the resulting product or the morphological group of the herbal drug is erroneous. The authors systematised and unified approaches to generic naming of herbal medicinal products with due regard to the species of source plants, the morphological groups of herbal drugs, and the production technology and composition of herbal medicinal products. The authors analysed typical errors in establishing conventional and generic names for herbal drugs and herbal medicinal products associated with incorrectly identified morphological groups of herbal drugs, incorrect source plant names, mismatching structures of Latin and Russian names of herbal drugs, erroneous Latin names of the resulting products, or wrongly assigned morphological groups of herbal drugs.CONCLUSIONS. According to the analysis of the names of herbal drugs, herbal drug preparations, and herbal medicinal products used in the State Pharmacopoeia of the Russian Federation (editions XI–XV), the Pharmacopoeia of the EAEU, and the European Pharmacopoeia, the terminology of these legal systems is harmonised to a high degree. The alignment of terminology is the closest between the regulatory documents of the EAEU and the EU. The terms and names used in Russia need further unification. The results of this study can be used in Russian pharmacopoeial practice to develop regulatory documents, prepare registration dossiers, and conduct expert reviews of submissions for herbal medicinal products.
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