At the request of Vademecum, the Pharmaceuticals & Healthcare Practice of VERBA LEGAL prepared an overview of the regulatory legal acts (RLAs) that entered into force in October 2025 and concern the circulation of medicines and medical devices. In addition, the lawyers highlighted several documents that will take effect later, as well as draft regulatory initiatives currently under development. A detailed breakdown of these documents is provided in this digest.
Circulation of Medicinal Products
• Ministry of Industry and Trade Plans to Subsidize the Development of Original Medicines
Draft Resolution of the Government of the Russian Federation
“On the Specifics of Providing Federal Budget Subsidies to Russian Organizations to Reimburse Part of the Costs of Projects for Developing Original Medicinal Products or Expanding Their Approved Medical Indications.”
The Russian Ministry of Industry and Trade (Minpromtorg) has drafted a government resolution outlining the specifics of granting subsidies from the federal budget to Russian pharmaceutical manufacturers. These subsidies are intended to reimburse part of the costs related to the development of original medicines or the expansion of their approved indications.
The subsidies will be provided under the federal project “Support for R&D in Civilian Industrial Sectors,” part of the state program “Scientific and Technological Development of the Russian Federation.” The 2026 budget exceeds 1.6 trillion rubles.
To qualify, an organization must own the marketing authorization (MA) for an original medicine developed under the priority areas defined by the Ministry of Health, and must also hold exclusive rights to the product in Russia.
A subsidy may be granted if:
– the MA for the original medicine (within the priority areas) was obtained no later than one year before the application submission to Minpromtorg;
– or the MA was obtained earlier, but post-registration clinical studies were completed within the last year, with MA amendments submitted to expand indications.
Reimbursement applies to actual expenses related to late-stage clinical trials and post-registration studies aimed at expanding indications. The maximum subsidy per project is 250 million rubles, with no limit on the number of projects per organization.
Subsidy funds may be used for:
– employee remuneration related to project implementation;
– material expenses;
– procurement of laboratory equipment and supplies;
– services of third-party organizations performing work in Russia.
The expected result is achieving revenue from product sales amounting to at least twice the subsidy received within three years after registration. Manufacturing must be localized within Russia.
If requirements or targets are not met, the subsidy must be returned to the federal budget in full, with penalties.
According to the explanatory note, this mechanism is intended to expand the range of domestic original medicines, boost proprietary R&D, and increase investment in new pharmaceutical products.
VERBA LEGAL notes that the project continues the general industry trend toward strengthening sovereignty in the Russian pharmaceutical market and encouraging localization. However, the subsidies cover only part of the development costs.
• Draft RLAs Prepared on Co-Financing Treatment of Patients with Rare (Orphan) Diseases
Draft Government Resolutions:
– “On the Criteria for Determining a Region’s Inability to Fulfil its Authority to Provide Citizens with Medicinal Products Registered in the Russian Federation for Treating Life-Threatening and Chronic Progressive Rare Diseases Leading to Reduced Life Expectancy or Disability, and the Procedure for Confirming Such Inability.”
– “On Approving the Rules for Providing and Allocating Federal Budget Subsidies to the Regions to Co-Finance their Expenditure Obligations Related to Providing Citizens with Medicinal Products Registered in the Russian Federation for Treating Life-Threatening and Chronic Progressive Rare Diseases Leading to Reduced Life Expectancy or Disability.”
The Russian government has prepared draft acts required for implementing the legislative reform enabling federal co-financing of treatment for patients with orphan diseases. The first draft outlines criteria and procedures for confirming that a region cannot independently meet its obligations to supply medicines for such patients.
A region may apply for federal support if it meets all the following criteria:
– the calculated budget sufficiency level before equalization does not exceed 0.65;
– the regional budget has increased funding for medicine provision by at least 10% compared to the previous year;
– the number of patients with orphan diseases has grown by at least 15%, and the cost of procured medicines has increased by at least 20%.
Compliance will be confirmed through a standard application form submitted to the Ministry of Health annually between August 1 and September 30.
The second draft establishes rules for providing and distributing federal subsidies to regions deemed unable to fulfill these responsibilities. Funds will be allocated through agreements via the “Electronic Budget” system. The outcome indicator will be the number of patients provided with medicines.
If approved, both resolutions will enter into force on January 1, 2026.
Circulation of Medical Devices
• National Rules for Registering Medical Devices Extended Until the End of 2027
Government Order No. 2920-r of October 17, 2025
“On Signing the Protocol Amending the Agreement on Unified Principles and Rules for the Circulation of Medical Devices within the EAEU (December 23, 2014).”
EAEU member states have drafted a protocol amending the agreement to extend the transition period until 2028. During this period, manufacturers will be allowed to register medical devices under national or EAEU rules if the devices are marketed in more than one member state. The extension is justified by the need to adapt to current economic conditions and preserve national regulatory systems.
The deadline for submitting applications under national rules is expected to be extended to the end of 2027, and the deadlines for re-registration and dossier amendments to the end of 2028.
The Russian government approved the protocol amendments on October 17, 2025. They will enter into force after they are signed by all EAEU members, with provisional application beginning within 10 days of each country’s signature.
General Regulation
• “Permanent” Online Advertising Reporting Requirement Abolished
Government Resolution No. 1427 of September 18, 2025
“On Amendments to Certain Acts of the Government of the Russian Federation.”
Amendments to the reporting rules for online advertising have entered into force. Now, companies must submit reporting data to the Unified Advertising Register (ORD) only within one year from the date the advertisement is published. This applies to ads in social networks, on digital platforms, and on websites.
The only exception is advertising integrated as part of a video (e.g., on YouTube or VK). These ads must still be reported for the entire duration of their publication under the previous rules.
Источник: Вадемекум, 01.11.2025.
