Recommendations on the procedure for determining the interchangeability of medicinal products
Abstract
The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»).
About the Authors
B. K. Romanov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
N. D. Bunyatyan
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Yu. V. Olefir
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
V. P. Bondarev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. B. Prokofyev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
R. I. Yagudina
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
R. N. Alyautdin
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. L. Kovaleva
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. P. Pereverzev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
K. E. Zatolochina
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. S. Kazakov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
A. V. Komratov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. Yu. Pasternak
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
References
1. The Federal law 22.12.2014 № 429-FZ «On amending the Federal law “On circulation of medicinal products”» (in Russian).
2. Summary report of the evaluation of regulatory impact. Available from: http://regulation.gov.ru/project/22466.html (cited 2015 Jan 12) (in Russian).
3. The Federal law 12.04.2010 № 61-FZ (as amended on 22.10.2014) "On circulation of medicinal products" (var. and additional) (in Russian).
4. Mironov AN, Vasiliev AN, Gavrishina EV, Niyazov RR. Interchangeability of drugs: international experience, the obstacles and the establishment of the concept in Russia, the role of scientific expertise. Remedium 2013; (10): 8–17 (in Russian).
5. Lepakhin V.K., Romanov B.K., Nikitina T.N., Snegiryova I.I. Expert evaluation of risk-benefit analysis of drugs. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2012; 2: 19-21 (in Russian).
6. Truus Janse-de Hoog. Interchangeability of generics. European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/ WC500107873.pdf (cited 2015 Jan 12).
7. Approved Drug Products with Therapeutic Equivalence Evaluations, 34nd (2014) [Orange Book]. United States Food and Drug Administration. Available from: http://www.accessdata.fda.gov/scripts/cder/ob (cited 2015 Jan 12).
8. Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 (Draft Guidance Updated for 508 on 3/22/12). Food and Drug Administration. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm259797.h tm (cited 2015 Jan 12).
Review
For citations:
Romanov B.K., Bunyatyan N.D., Olefir Yu.V., Bondarev V.P., Prokofyev A.B., Yagudina R.I., Alyautdin R.N., Kovaleva E.L., Pereverzev A.P., Zatolochina K.E., Kazakov A.S., Komratov A.V., Pasternak E.Yu. Recommendations on the procedure for determining the interchangeability of medicinal products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):3-8. (In Russ.)
Views:
728
Email this article 