HOMEOPATHIC MEDICINAL PRODUCTS REGISTRATION IN THE RUSSIAN FEDERATION AND ABROAD
DOI: https://doi.org/None
Issue:
6
Year:
2015
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
References:
- Filippova I. Gomeopatiya: bol`shie problemy «malen`kih» lekarstv. Remedium, 2010; 3: 6–10.
- Yudin V. Gomeopatiya v e`ru dokazatel`noy mediciny: voprosy obrazovaniya i regulyatornoy politiki. Ezhenedel`nik «Apteka», 2009; 6 (677), 09.02.2009.http://pharmapractice.ru/3468 (data obrashheniya 19.05.2015).
- Federal`nyy zakon RF № 61-FZ ot 12.04.2010 «Ob obrashhenii lekarstvennyh sredstv», URL: http://base.garant.ru/12174909/ (data obrashheniya 19.05.2015).
- DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). URL: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf (data obrashheniya 19.05.2015).
- DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human/ URL: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf (data obrashheniya 19.05.2015).
- Ramenskaya G.V., Davydova K.S.. Evropeyskaya farmakopeya 7-go izdaniya: obshhie svedeniya i struktura. Vedomosti NCE`SMP, 2011; 2: 47–49.
- Polyakova D. Osobennosti razvitiya gomeopatii: nekotorye voprosy regulirovaniya gomeopaticheskoy farmacii v SShA i Kanade. Ezhenedel`nik «Apteka», 2004; 24 (445) 21.06.2004 http://www.apteka.ua/article/15408
- Moshhich A.P., Tumanov V.A. Gomeopatiya i gosudarstvennaya sistema zdravoohraneniya. Obzor nekotoryh mezhdunarodnyh osnovopolagayushhih aspektov vzaimootnosheniy. Ukrainskiy gomeopaticheskiy ezhegodnik, 2007; 10: 56.
- Farmacevticheskiy sektor: Obshhiy tehnicheskiy dokument dlya licenzirovaniya lekarstvennyh sredstv v ES (pod red. A.V.Stefanova). K.: MORION, 2002; 256.
- Reshenie Kollegii i Byuro Ministerstva zdravoohraneniya i medicinskoy promyshlennosti Rossiyskoy Federacii «Ob ispol`zovanii metoda gomeopatii v prakticheskom zdravoohranenii» Protokol № 26 ot 27 dekabrya 1994 g. http://www.gomeopatiya.org/content/6/prikazy-minzdrava.html (data obrashheniya 19.05.2015).
- Prikaz Ministerstva zdravoohraneniya i medicinskoy promyshlennosti № 335 ot 29 noyabrya «Ob ispol`zovanii metoda gomeopatii v prakticheskom zdravoohranenii». http://www.homeomed.ru/prikaz.htm (data obrashheniya 19.05.2015).
- Metodicheskie ukazaniya MZ i MP RF «O poryadke doklinicheskogo i klinicheskogo izucheniya preparatov prirodnogo proishozhdeniya i gomeopaticheskih lekarstvennyh sredstv». M., 1994.
- Federal`nyy zakon № 86-FZ ot 22 iyunya 1998 g. «O lekarstvennyh sredstvah». http://www.legis.ru/misc/doc.php?id=900
- Gerasimov V.B., Shih E.V., Bulaev V.M., Il`enko L.I., Tomkevich M.S., Gil`deeva G.N., Martynov A.I., Pashina O.E. Instrukciya po provedeniyu klinicheskih issledovaniy novyh gomeopaticheskih lekarstvennyh sredstv. Rukovodstvo po provedeniyu klinicheskih issledovaniy novyh lekarstvennyh sredstv. M.: Russkiy vrach, 2005; 320–337.
- Korvyakova O.A. Rossiyskaya gomeopaticheskaya farmakopeya – aktual`naya problema dal`neyshego razvitiya metoda gomeopatii v mire. http://www.polykrest.od.ua/other/years_articles243.php
- Sayt Ministerstva zdravoohraneniya RF http://www:rosminzdrav.ru/ministry/61/11materialy-po-deyatelnosti-departamenta/stranisa-856/spisok-proektov-
- Issledovaniya v oblasti gomeopatii. http://www.hevert.com/market-ua/ru/products/homeopathy-research
- Bellavite P., Ortolani R. et al. 'Immunology and Homeopathy'. Lecture 5. The Rationale of the ‘Simile. Evidence-based Complementary and Alternative Medicine, 2007; 4:149–163.
- Novosadyuk T.V., Sokolov V.D., Komissarenko A.A. Nauchnye issledovaniya i dokazatel`nost` v gomeopatii. Veterinarnaya patologiya, 2008; 3:115-119.
- Sankaran R. Homeopathy. The Science of healing. http://balausa-kz.com/o-gomeopatii/ststi-r-shankarana/item/41-gomeopatiya-magiya-minimuma (data obrashheniya 19.05.2015).
- Kovalenko L.P., Tallerova A.V., Kuznecov O.S., Alekseeva S.V. E`ksperimental`noe izuchenie allergiziruyushhih svoystv i immunotoksichnosti preparata «Ocillokokcinum». Toksikologicheskiy vestnik, 2015;1: 37–41.
- Bulaev V.M. E`ffektivnost` i bezopasnost` gomeopaticheskih lekarstvennyh sredstv, zaregistrirovannyh v Rossiyskoy Federacii. Gomeopaticheskiy ezhegodnik. Materialy XXIII Moskovskoy mezhdunarodnoy gomeopaticheskoy konferencii «Razvitie gomeopaticheskogo metoda v sovremennoy medicine». M.: 2013; 222–229.
- Rukovodstvo po provedeniyu doklinicheskih issledovaniy lekarstvennyh sredstv. Chast` 1. M.: Grif i K, 2012; 944.
- Tomkevich M.S. Klinicheskie issledovaniya v gomeopatii. Tradicionnaya medicina, 2011; 3: 14–25.
- Bellavite P., Marzotto M., Olioso D. et al. High-dilution effects revisited. 2. Pharmacodynamic mechanisms // Homeopathy.- 2014;103:22–43.
- R.T. Mathie, S.M. Lloyd, L.A. Legg et al. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst.Rev.- 2014; 3:142.