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The Accounts Chamber indicated the long duration of the drug registration procedure

10/15/2019 | drug registration, pharmaceutical industry

The Accounts Chamber of the Russian Federation in its analysis of state programs as part of the Opinion on the draft federal law “On the federal budget for 2020 and the planning period 2021 and 2022” indicated that the procedure for registering drugs in Russia is too long in time, and therefore in 2018 the planned value of the main indicator “The volume of production of domestic medicines, domestic medical devices in monetary terms due to the commercialization of the created technologies” was not achieved.

As indicated in the report on the state program “Development of the pharmaceutical and medical industries”, failure to achieve the planned value of the indicator “The volume of production of domestic medicines, domestic medical devices in monetary terms due to the commercialization of created technologies, percent” (with the plan of 149.0 billion rubles, the actual value is 72.0 billion rubles) is associated with the duration of the state registration of medicines and medical devices developed as part of existing programs and documents (medicines and medical devices developed as part of the state program are in the registration stage and have not been put on the market).

Monitoring of registration procedures for medicines and medical devices is carried out by the Ministry of Industry and Trade of the Russian Federation together with the Ministry of Health of the Russian Federation as part of the Interdepartmental Working Group to improve the efficiency of the state program (approved by joint order of the Ministry of Industry and Trade of Russia and the Ministry of Health of Russia dated April 3, 2016 No. 599 / 151н).

The analytical report also indicates that the containment of supplies in the public sector is subjective due to a general distrust of Russian drugs and preference for foreign-made medicinal products and is due not so much to the technological lag of Russian products from their foreign counterparts, but to the significant opportunities of foreign companies to marketing their products to the end consumer and the general preference for imported drugs from the end consumer - health care providers that is in some cases subjective.

For a number of indicators in 2017, 2018, the planned values were not fulfilled, and their values for the period 2020–2022 were reduced relative to the values indicated in the current version of the state program. Among the reasons:

• revision by organizations of the pharmaceutical and medical industries of plans for scientific development and investment strategies in connection with the change in the mechanism of state support since 2020;
• lack of a sufficient number of industrial partners interested in further research and commercialization of domestic developments;
• reduction in the financial capabilities of Russian companies - manufacturers of medical devices and medicines to promote their products in foreign markets, taking into account the need for significant investments in measures for the registration of drugs and products in foreign countries.

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