Email this article ASSESSMENT OF ACTUAL TERMS OF REGISTRATION EXAMINATION OF MEDICINES FOR 2011-2018
- Authors: Olefir Y.V1, Koshechkin K.A.1, Romanov B.K1
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Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products
- Issue: Vol 24, No 6 (2018)
- Pages: 306-309
- Section: Articles
- URL: https://journals.rcsi.science/0869-2106/article/view/38482
- DOI: https://doi.org/10.18821/0869-2106-2018-24-6-306-309
- ID: 38482
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Abstract
The key issue in discussing the possibility of entering the pharmaceutical market of the Russian Federation are aspects of the fulfillment of state registration expertise procedures. Estimation of the timing of its implementation suggests a change in the efficiency of the entire system for regulating the circulation of medicines. A reduction in the total actual period from the receipt of the first application for registration of a drug to the receipt of a positive opinion from 340 to 311 calendar days on average was established. At the same time, the number of negative opinions decreased from 52% to 7%. On the basis of the obtained data, it was concluded that there is a general tendency to accelerate the release of new drugs to the market.
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##article.viewOnOriginalSite##About the authors
Yu. V Olefir
Scientific Centre for Expert Evaluation of Medicinal Products127051, Moscow, Russian Federation
Konstantin A. Koshechkin
Scientific Centre for Expert Evaluation of Medicinal Products
Email: koshechkin@expmed.ru
candidate of biological sciences, Head of Informatization department «Scientific Centre for Expert Evaluation of Medicinal Products» 127051, Moscow, Russian Federation 127051, Moscow, Russian Federation
B. K Romanov
Scientific Centre for Expert Evaluation of Medicinal Products127051, Moscow, Russian Federation
References
- Послание Президента Федеральному Собранию 1 марта 2018 года http://kremlin.ru/events/president/news/56957
- Стратегия развития здравоохранения Российской Федерации на период до 2025 года https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/strategiya-razvitiya-zdravoohraneniya-rossiyskoy-federatsii
- Государственная программа «Развитие фармацевтической и медицинской промышленности» на 2013-2020 годы. Утверждена постановлением Правительства от 28 декабря 2017 года № 1673. http://government.ru/programs/219/events
- Федеральный закон от 12.04.2010 N 61-ФЗ (ред. от 03.07.2016) «Об обращении лекарственных средств» (с изм. и доп., вступ. в силу с 01.01.2017) По правовой информационной системе «Консультант»
- Good Practice Practice: Review of Marketing Applications for Breakthroughs and Practice MAPP 6025.7 [Electronic resource]. URL: http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm437281.pdf
- FDA: CDER and CDRH Perspectives FDA Small Business Regulatory Education for Industry (REdI) Burlingame, CA June 16, 2014 [electronic resource]. URL: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ UCM407884.pdf
- Myers, James (2003). Collaborative Electronic Notebooks as Electronic Records for the Electronic Notebooks (ELN) (PDF). Proceedings of the 2003 International Symposium On Collaborative Technologies and Systems. [electronic resource]. URL: http://collaboratory.emsl.pnl.gov/resources/publications/papers/seceln (final1) 1-22Nov.pdf (access date 13.08.2015).
- Shah, Kim, “Elevating laboratory informatics to assist decision-making”, Pharmaceutical Technology Europe, 2009, 21 (5) [electronic resource]. URL: http://www.pharmtech.com/elevating-laboratory-informatics-assist-decision-making (request date 13.08.2015).
