The Entry Lag of Innovative Drugs in Russia, 2010–2019

Abstract

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

Impact on the Availability of Food Supplements and Medicines in the Russian Federation during Legislative Changes in 2010: A Case Study

“…Other authors have referred to the same historical time, stating that due to impacts of market factors and imperfections in the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the US, the EU, and Japan. The average time from the moment a drug is initially approved in the aforementioned countries and jurisdictions to the moment of registration in Russia, is 4 years and 8 months, with a median value of 2.5 years [8].…”

“…In a recent study related to the MA of original drugs in Russia after the NPL, it was found that due to impacts of market factors and the imperfections of state regulation, foreign drugs enter the Russian market a few years after their registration in the US, the European Union (EU), and Japan. The authors concluded that to attain the goal of adequate supplies for the population of the most up-to-date drugs, Russia must upgrade the existing system of original drug registration [8]. Despite initially declared improvements, the MA system experienced a lack of transparency concerning the procedures, leading to frequent amendments.…”

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“…Additionally, if additional clinical studies, quality assurance measures, or requests for additional clinical evidence from regulatory agencies were made, the licensing deadline would be postponed. But typically, the production of a Registry Certificate took approximately 18 months, with Stage I taking around two months, Stage II about twelve months, and Stage III about four months 20 .…”