Considerations regarding demonstration of efficacy and safety of homeopathic medicines
Abstract
The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate evaluation criteria the authors took into account specificity of homeopathic medicines composition and dosage form formulation, specific characteristics of pharmaceutical substances and therapeutic action, as well as known limitations on the use of standard test methods. The key criteria for homeopathic medicines evaluation are: compliance of the substance quality and the drug production technology with corresponding pharmacopoeial requirements, substantiation of the drug composition safety, and confirmation of the proposed efficacy and safety by the evidence-based pre-clinical and clinical programme.
About the Authors
R. D. Syubaev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. M. Krutikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
G. N. Engalycheva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. G. Olenina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/eqylO3 (in Russian).
2. Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/0BcLTp (in Russian).
3. Order of the Ministry of Health of the Russian Federation of 13.12.2012, No. 1041n «On amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No. 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/zCwXKQ (in Russian).
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Review
For citations:
Syubaev R.D., Krutikova N.M., Engalycheva G.N., Olenina N.G. Considerations regarding demonstration of efficacy and safety of homeopathic medicines. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(2):98-103. (In Russ.)
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