ASSESSMENT OF ACTUAL TERMS OF REGISTRATION EXAMINATION OF MEDICINES FOR 2011-2018

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.

Keywords

medicines market authorization / medicines expertise / regulatory information management systems / pharmacy informatization / digital pharmaceuticals

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