The Government of the Russian Federation has approved an action plan for implementing the strategy for the development of the pharmaceutical industry until 2030 (the “Pharma-2030” strategy), which was adopted in June 2023. The plan includes 40 specific measures related to financing new developments and expanding production, ensuring the quality of medicines, and improving regulatory frameworks, GxP News reported in the Ministry of Industry and Trade.

Special attention in the plan is paid to accelerating the scientific and technological development of the pharmaceutical industry, including through the creation of clear and specific guidelines for drug manufacturers, as well as systemic measures to support production organization and increase export potential, which will help achieve the goals of the strategy. The document was developed following discussions with the professional expert community and relevant government agencies. This allowed for considering the opinions of all stakeholders in drug regulation.

The plan’s activities address all the goals and objectives outlined in the strategy, including the development of systemic measures to support drug production in Russia, expanding access to the Russian pharmaceutical market, improving drug pricing, and prioritizing Russian pharmaceutical products. Additionally, there are plans to improve the regulation of drug circulation, including the regulatory and legal framework in this area, supporting the export of Russian pharmaceutical products (including harmonizing regulations with evolving best global practices). Important directions include creating a common research infrastructure and systems for shared use of this infrastructure; decomposing tasks for industries adjacent to the pharmaceutical industry; and preparing scientific, technological, and production personnel for the Russian pharmaceutical industry.

In 2026, monitoring the implementation of the plan’s activities is planned, along with preparing updates for 2027-2030 with emerging new tasks and challenges.

Reminder: The Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030 was adopted by the decree No. 1495-r of the Government of the Russian Federation dated June 7, 2023. The main focus of the strategy is to increase competitiveness and import substitution, which aligns with the interests of citizens in the sphere of health preservation and the goals of the state.

Key indicators:

• Increasing the volume of the pharmaceuticals market for medical use in the Russian Federation from 2.25 to 3.76 trillion rubles;
• Increasing the share of pharmaceuticals for medical use produced in Russia in the total consumption volume in monetary terms from 36.6 to 42.7%;
• Increasing the share of pharmaceuticals for medical use according to the list of strategically significant pharmaceuticals (approved by the decree of the Government of the Russian Federation dated July 6, 2010), manufactured through the full cycle, including the production of the pharmaceutical substance, from 67.44 to 80% (within the list of 215 names approved by the decree of the Government of the Russian Federation dated August 1, 2020, No. 2015-r);
• Increasing the volume of exports of pharmaceuticals for medical use produced in the Russian Federation in monetary terms from 1.28 to 3.4 billion rubles.

Source: GxP news, 11.04.2024.