Regulation of Herbal Medicinal Products in Russia

Herbal medicine preparations (HMP) are official medicine in Russia and more that 600 HMP are on the medicinal market. All aspects relating to the development, preclinical and clinical studies, evaluation, state registration, standardization and quality control, manufacturing, preparation, storing, transporting, importing and exporting, advertising, releasing, selling, using, and disposing of pharmaceutical preparations (including HMP) are regulated by Federal Law No. 61 FZ (12.04.2010) “About circulation of drugs“.

HMP is the finished product and classified into the following categories: medicinal plant material, galenic formulations, novo-galenic formulations, active pharmaceutical ingredients and combined phyto-preparations. HMP must follow the national drug standards: OST 91500.001–00 “Standards for quality of medicinal drugs – Basic provisions“ (which sets out the categories, development procedures, wordings, filing, expertise, approval and designation of quality standards) and the 12th State Pharmacopoeia of Russian Federation (main state quality standard of pharmaceutical preparations).

The application requirements for state registration of pharmaceutical preparations and documents of the drug master file are the same for domestic and foreign manufacturers. All applications for registration of pharmaceutical preparation in Russian Federation are subject of evaluation of safety and efficacy of pharmaceutical preparation and approving of permission for clinical trials; examination of the proposed methods for quality control of the drug and the quality of the drug samples using these techniques; evaluation of the relationship between expected benefit and possible risk of drug application after its clinical study.

The current regulatory and technical documents, standardization and quality control systems, ensure that patients interests are duly adhered to, and guarantee the supply of high quality pharmaceutical preparations and HMP.