Efficacy and Safety of Herbal Medicinal Products: Registration Requirements in the EAEU and Other Regions of the World (Review)

INTRODUCTION. Herbal medicinal products are widely used in medical practice. Special considerations apply to the extent of safety and efficacy studies required for herbal medicinal products in different countries, as documented in their marketing authorisation frameworks. Currently, the Eurasian Economic Union (EAEU) lacks guidelines on the extent of preclinical and clinical studies required for herbal medicinal products.

AIM. This study aimed to analyse the possibility of using international standards and approaches in the development of the EAEU guidelines for preclinical and clinical studies of the safety and efficacy of herbal medicinal products.

DISCUSSION. First of all, marketing authorisation of herbal medicinal products involves special considerations because these medicinal products contain complex mixtures of bioactive substances. According to the analysis of the regulatory approaches of the European Union (EU), the United States of America (USA), and the EAEU, the safety and efficacy testing requirements for herbal medicinal products are harmonised to a certain degree. The terms used for herbal substances and herbal medicinal products have almost identical definitions in all the studied documents. Despite the differences in their typological classifications of herbal medicinal products, the EU and USA documents provide similar principles for determining the required extent of published data and original studies on the safety and efficacy of herbal medicinal products. Mainly, the extent depends on the herbal medicinal product’s history of previous human use and completed preclinical and clinical studies (if any), type (original/generic), intended administration route (traditional/new), and indications (established/new). Some of the approaches presented in the article are only partially included in the current EAEU regulatory documents.

CONCLUSIONS. The discussed approaches can be considered in the development of the EAEU guidelines for preclinical and clinical studies of the safety and efficacy of herbal medicinal products. Such guidelines will contribute to providing the population with broad-spectrum herbal medicinal products that meet current safety and efficacy standards.

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