Modern approaches to herbal preparations efficacy and safety assessment in Russia and abroad

For the purpose of prevention and treatment of various diseases, herbal medicinal products are used along with a wide range of small molecule drugs. Herewith herbal preparations are not only herbs and combined herbal products, but also various galenic and new galenic preparations and individual biologically active compounds derived from plants. The growth of demand for herbal medicinal product, the changing requirements of the regulatory system to their safety and effectiveness during the procedure of registration puts certain tasks to improve this procedure. The article provides an overview of the literature data on contemporary requirements for safety and efficacy assessment of herbal preparations. Analysis of approaches to conducting preclinical and clinical studies of herbal preparations in Russia and the international community led to certain conclusions on the degree of their harmonization and possible unification.

лекарственные средства растительного происхождения, лекарственный препарат, безопасность, эффективность, доклинические исследования, клинические исследования, регистрация, herbal preparations, medicinal product, safety, efficacy, preclinical studies, clinical studies, marketing authorization

1. General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine. Geneva: WHO; 2000. Available from: http://apps.who.int/medicinedocs/en/d/Jwhozip42e/.

2. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines. Manila: WHO Regional office for the Western Pacific; 1993. Available from: http://whqlibdoc.who.int/wpro/-1993/9290611103.pdf.

3. Directive 2001/83/ЕС of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to Medicinal Products for Human Use with amendments. Official Journal L–311, 28.11.2004; 67-128.

4. Directive 2004/24/EC of the European Parliament and the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal L–136, 30.04.2004; 85–90.

5. European Medicines Agency. Available from: http://www.ema.europa.eu/ema/index.jspcurl=pages/regulation/general/general_content_000208.jsp.

6. Guideline on the assessment of clinical safety and efficacy in the preparation of community herbal monographs for well-established and of community herbal monographs/entries to the community list for traditional herbal medical products/substances/preparations. London, 7 September 2006. Doc. Ref. EMEA/HMPC/104613/2005. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003644.pdf.

7. Guideline on clinical assessment of fixed combination of herbal substances/herbal preparations. London, 11 January 2006. Doc. Ref. EMEA/HMPC/166326/2005. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC 500003645.pdf

8. Methodical instructions on the procedure for pre-clinical and clinical study of drugs of natural origin and homeopathic medicines. Ministry of Health and Medical Industry of the Russian Federation, Office of the State quality control of medicines and medical equipment. Moscow; 1994.

9. Mironov AN, ed. Guidelines for pre-clinical trials of drugs. Part I. Moscow: Grif i K; 2012.

10. Lesiovskaya EE, Verstakova OL, Arzamastsev EV, Paskhina OE, et al. Criteria for assessing the efficacy and safety of herbal drugs on the stage of pre-clinical trials and pre-registration pharmaco-toxicological examination. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya 2007; (4): 77–83.

11. Krepkova LV, Bortnikova, Sokolskaya TA. Some aspects of the toxicological study of drugs based on medicinal plants. Fundamentalnye issledovaniya 2013; 9(2): 256–8. Available from: www.rae.ru/fs/?section=content&op=show_article&article_id=10001465.

12. Habriev RU, ed. Guidelines for clinical trials of new drugs. Moscow: Meditsina; 2005.