The Russian government plans to develop a system for expediting the registration of medicines

09 January 2024

GxPNews

Prime Minister Mikhail Mishustin has issued a directive to draft a law aimed at regulating the development and registration of medical technologies in Russia. This is one of the stages for the implementation of the “megaproject” to improve the pharmaceutical industry, announced earlier. Deputy Prime Minister Tatyana Golikova was appointed responsible for implementation. This information is mentioned on the government website in a dedicated publication focusing on the outcomes of the strategic session “On major projects of technological sovereignty.”

The Ministry of Health will prioritize including scientific research on the development of original medicines, popular medical products, and medical technologies for diagnosing and treating various diseases in state assignments. The deadline for submission is January 25, 2024.
Furthermore, the Ministry of Health and the Ministry of Industry and Trade have been directed to collaborate on developing mechanisms to streamline the registration process for drugs. They are also tasked with updating the “road maps” for localizing the production of medicines and medical devices. Furthermore, they will collaborate closely with Roszdravnadzor and Rospotrebnadzor in order to guarantee that the information regarding the prerequisites for the planning of medication and medical device development and production remains current.

These same ministries, together with the Ministry of Economic Development, the Federal Antimonopoly Service and Rospatent, will submit proposals by February 1, 2024 to improve the procedure for applying patent law mechanisms for the most popular and strategically important foreign drugs.

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