Criteria for Forming the List of Strategically Significant Medicines

23 September 2025
Alena Troitskaya
Junior Associate
Ivan Tarasenko
Legal Trainee

On 1 September 2025, a draft resolution of the Government of the Russian Federation “On approving the procedure and criteria for compiling a list of strategically significant medicines” (“Draft Resolution”) was submitted for public discussion.

The Draft Resolution aims to review and bring the current list of strategically significant medicines (“List”), approved by Decree of the Government of the Russian Federation No. 1141-r of 6 July 2010, into line with the new rules for its formation.

This List was compiled with the aim of increasing the economic accessibility of medicines to meet priority healthcare needs, prevent and treat diseases, including those prevalent in the Russian Federation, and provide state support. In addition, the production of medicines included in this List must be carried out exclusively within the territory of the Eurasian Economic Union (“EAEU”) at all stages of production.

Commission

A special commission formed and supported by the Ministry of Health will be responsible for compiling the List of strategically significant medicines. The commission will meet no more than once a quarter if there are proposals to add or remove medical products from the List, which must come from entities involved in the circulation of medicines and/or federal executive authorities of the Russian Federation. The commission’s decision on inclusion/exclusion from the List shall be taken collectively at commission meetings by a two-thirds majority vote.

Currently, there are 215 medicines on the List. The Draft Resolution provides for the formation of a List consisting of two sections, each of which will be formed in accordance with specific criteria.

General criteria for inclusion in the first and second sections of the List

Both sections of the List include medicinal products that meet the following criteria (clause 4 of the Draft Resolution ):

  • The medicinal product is registered in accordance with the EAEU registration rules and is included in the register of medicinal products for medical use and/or the register of registered EAEU medicinal products;
  • The medicinal product is included in the list of essential and vital medicinal products;
  • The medicinal product has been purchased to meet state/municipal needs over the last three calendar years.

First section

In addition to meeting the general criteria specified in clause 4 of the Draft Resolution, in order to be included in the first section of the List, a medicinal product must meet at least one of the criteria listed below (clause 5 of the Draft Resolution):

  • The medicinal product is intended for the immunoprophylaxis of infectious diseases1;
  • The medicinal product is derived from human blood or blood plasma and is a blood substitute, perfusion and/or infusion solution;
  • The medicinal product is included in the list of narcotic drugs, psychotropic substances and their precursors2.

Second section

To be included in the second section of the List, a medicinal product must meet all of the following criteria:

  • meet the general criteria specified in paragraph 4 of the Draft Resolution;

  • be included in clinical guidelines3;

  • have no other registered medicinal products in the Russian Federation with other international non-proprietary names used within the same medical indication and 4th level anatomical therapeutic chemical classification code (chemical subgroup) of the EAEU, or the technological capability to manufacture such a medicinal product at all stages of production in the territory of the EAEU member states must be ensured.

It must also meet at least one of the following criteria:

  • The medicinal product is intended for the prevention and treatment of diseases included in the List of socially significant diseases and the list of diseases that pose a danger to others;

  • The medicinal product is intended for the prevention and treatment of diseases included in  the List of Diseases, Defects, Irreversible Morphological Changes, Disorders of Organs and Body Systems, as well as Indications and Conditions for Establishing Disability Groups and the Category of “Disabled Child”;

  • The medicinal product is antibacterial;

  • The medicinal product is intended for the prevention and treatment of diseases specified in federal projects that are part of the national project “Long and Active Life”.

Further consideration of the Draft Resolution

If the Draft Resolution is adopted, the Ministry of Health is expected to complete its review of the List’s compliance with the new criteria for its formation by 20 November 2025.

Key issues

Inclusion in the List of Medicines still under patent protection requires the organization of their full production cycle within the EAEU. This requirement entails high costs, which may reduce the interest of foreign pharmaceutical companies in bringing innovative medicines to the Russian market. This, in turn, may increase the risk of a shortage of new medicinal products on the Russian market and reduce its investment attractiveness.

In addition, foreign pharmaceutical companies that decide to localize production in the Russian Federation will face higher transaction costs, which may lead to a significant increase in medicinal products prices.

If this approach to forming the List is enshrined in the final version of the Draft Resolution, it could lead to the following negative consequences:

  1. A decline in the investment attractiveness of the industry.

  2. Monopolization of the market in favor of a narrow circle of full-cycle manufacturers.

  3. Damage to competition, slowing down the development of innovative medicinal products in the Russian Federation and, as a result, may affect the availability of medicinal products for patients.


1In accordance with Order No. 1122n of the Ministry of Health dated 6 December 2021 “On the approval of the national calendar of preventive vaccinations, the calendar of preventive vaccinations for epidemic indications and the procedure for preventive vaccinations”.
2In accordance with Resolution of the Government of the Russian Federation No. 681 of 30 June 1998 “On the Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation”.
3Approved in accordance with Article 37 of Federal Law No. 323-FZ of 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation”.