Open AccessASSESSMENT OF ACTUAL TERMS OF REGISTRATION EXAMINATION OF MEDICINES FOR 2011-2018
Author(s) -
Yu. V. Olefir,
К. А. Кошечкин,
Б. К. Романов
Publication year - 2018
Publication title -
rossijskij medicinskij žurnal
Language(s) - English
Resource type - Journals
eISSN - 2412-9100
pISSN - 0869-2106
DOI - 10.18821/0869-2106-2018-24-6-306-309
Subject(s) - receipt , circulation (fluid dynamics) , russian federation , business , estimation , key (lock) , medicine , actuarial science , computer science , operations research , accounting , economics , computer security , mathematics , engineering , economic policy , aerospace engineering , management
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.