SPECIFIC ASPECTS OF BENEFIT-RISK EVALUATION OF HERBAL MEDICINAL PRODUCTS: ANALYSIS OF REGISTRATION DOSSIERS

Abstract

The use of medicinal plants for therapeutic purposes (herbal medicine) is still popular nowadays. The aim of the present paper was to analyse registration dossiers for herbal medicines submitted for expert evaluation in accordance with the current national legal requirements for dossier compilation and methodological approaches to the examination of the benefit-risk ratio of herbal medicinal products. The article describes specific features of the preclinical and clinical sections of the common technical document for herbal medicinal products. The article also considers current national requirements for safety and efficacy evaluation of herbal medicinal products. It analyses specific aspects of preclinical (toxicological, pharmacokinetic and pharmacological) and clinical trials of medicines. Based on the results of the analysis the authors elucidate the main mistakes in the preparation of the necessary documents for registration dossiers for herbal medicinal products, namely: lack of complete information on the preclinical toxicological study of the product; inconsistencies in the product composition as specified in different documents; lack of statistical analysis of the results of studies; errors in draft patient information leaflets for herbal medicinal products. The materials presented in the article are high on the agenda and will help applicants properly compile registration dossiers for herbal medicinal products.

Keywords

• herbal drug
• herbal medicinal product
• registration dossier
• safety
• efficacy
• preclinical studies
• clinical studies