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HOMEOPATHIC MEDICINAL PRODUCTS REGISTRATION IN THE RUSSIAN FEDERATION AND ABROAD

DOI: https://doi.org/None
Issue: 
6
Year: 
2015

N.G. Olenina, N.M. Krutikova, PhD, R.D. Syubaev, PhD, G.N. Engalycheva, PhD, A.N.Vasiliev, PhD, Professor N.D. Bunyatyan, PhD Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation (FSBI «SCEEMP» of the Ministry of Health of Russia), 8 Petrovskiy boulevard, Moscow 127051, Russian Federation

Currently, the homeopathic method of treatment is rather widely used across the world. The article includes a summary of approaches to homeopathic medicinal products (HMP) registration abroad (in the EU, the USA and Canada) and in the Russian Federation, and describes peculiarities of these approaches in comparison with allopathic medicines. It generalizes the data on preclinical and clinical studies in the area of homeopathy and the details of formation of the evidential base on homeopathic medicinal products efficacy and safety. Lately, there has been noted a substantial increase in the level of HMP preclinical and clinical studies due to gradual implementation of the scientific evidence-based approach in this area of medicine. The homeopathic method’s of treatment specificity will require adjustment of the evidence-based medicine methods towards homeopathy to a certain extent. Developing the approaches to homeopathic medicinal products registration in the Russian Federation, both the experience of Russian regulatory authorities and the harmonization process in the sphere of drug circulation should be considered.

Keywords: 
homeopathy
homeopathic medicinal products (HMP)
Homeopathic Pharmacopoeia
homeopathic medicinal products registration

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