Review of pharmaceutical regulations – October 2025

Overview of key changes in Russian pharmaceutical legislation in October 2025.

The EEC has approved changes to the rules for the registration and examination of medicinal products

The Board of the Eurasian Economic Commission (EEC) approved a draft decision “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use.” On October 17, 2025, the corresponding order of the EEC Board No. 148 dated October 14, 2025, was officially published. “On the draft decision of the Council of the Eurasian Economic Commission ”On Amendments to the Rules for the Registration and Examination of Medicinal Products for Medical Use” on the legal portal of the Eurasian Economic Union (EAEU).

The purpose of the changes is to implement the necessary updates to regulations governing the circulation of medicines in EAEU countries. Changes are being made to the rules for conducting expert reviews, preparing registration dossiers, and standardizing all requirements for documents submitted for the registration of medicinal products in EAEU countries.

The updated EEC rules are designed to improve cooperation between the authorized bodies and experts of the union countries when reviewing registration dossiers for medicinal products. In addition, the document introduces the concept of “confidential data” — information protected as a trade secret, which includes information about the manufacturing process, inspection results, and the applicant’s or registration certificate holder’s strategy for further registration actions.

In addition, the order introduces amendments to the procedure for interaction between national authorized bodies and expert organizations when reviewing registration materials.

It is expected that the updated rules will reduce the time required for dossier evaluation, increase the transparency of quality control procedures, and improve the efficacy and safety of medicinal products.

The document will come into force on the date of its publication on the official website of the Eurasian Economic Union.

Link: https://docs.eaeunion.org/documents/445/10238/

October 24, 2025

The Russian government has drafted a resolution on centralizing the procurement of medicines and medical devices for national projects

The Russian Ministry of Health plans to centralize the procurement of medicines and medical devices for two national projects: “Long and Active Life” and “Family.” The corresponding draft resolution of the Russian Government “On the centralization of procurement of certain types of medicines for medical use and medical devices to meet state needs for the implementation of measures (results) of federal projects that are part of the national projects ”Long and Active Life“ and ”Family,” prepared by the Russian Ministry of Health, has been posted on the portal for draft regulatory legal acts.

In accordance with Parts 2, 6, and 10 of Article 26 of the Federal Law “On the Contract System in the Sphere of Procurement of Goods, Works, and Services for State and Municipal Needs,” the document assigns to the Federal Center for Planning and Organization of Drug Provision to Citizens (FCPOD) of the Ministry of Health of Russia with the authority to determine suppliers for all state medical institutions within the framework of national projects when purchasing medical devices according to the list proposed for approval by the draft resolution, as well as medicines. It is planned to purchase centrally:

– medical devices (medical equipment), including diagnostic, surgical, and resuscitation equipment (36 different items in total);

– medications for the prevention of cardiovascular diseases and their complications (the list will be approved by the Ministry of Health of the Russian Federation);

– antiviral drugs for the treatment of hepatitis C (the list will be approved by the Ministry of Health of the Russian Federation).

Customers must submit information to the Federal Center by September 1 each year on the quantity of medicinal products for medical use and medical devices required for procurement in the next financial year. By October 1, applications for purchases for the next calendar year must be completed and submitted in the prescribed form. In 2026, accelerated deadlines (by December 1 and December 10) will be introduced to prepare the system for launch.

It is envisaged that the resolution will apply to relations arising in connection with the procurement of medicinal products for medical use and medical devices to meet state needs, the financial provision for which is included in the federal budget for 2026 and subsequent years.

Link: https://regulation.gov.ru/projects/161319/

October 21, 2025

The Eurasian Economic Commission has adopted Guidelines for Planning Pharmaceutical Inspections

The Board of the Eurasian Economic Commission, in accordance with paragraph 7 of Article 7 and Article 10 of the Agreement on Uniform Principles and Rules for the Circulation of Medicinal Products within the Eurasian Economic Union of December 23, 2014, with a view to developing common approaches to risk assessment in relation to the planning of pharmaceutical inspections, approved, by its Recommendation No. 27 of October 14, 2025, the Guidelines for the Planning of Pharmaceutical Inspections for Compliance with the Requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union Based on Risk Assessment.

The guidance provides recommendations on determining the frequency, scope, and periodicity of pharmaceutical inspections of sites manufacturing medicinal products, based on a risk assessment of each individual production facility. Internal factors related to the specific characteristics of the manufacturing process and the hazards of the medicinal products manufactured are taken into account, as well as risks arising from non-compliance with Good Manufacturing Practice.

It is expected that the application of this document will enable the pharmaceutical inspectorates of the EAEU member states to optimally plan resources for the implementation of the annual plan (schedule) of inspections, as well as preserve the approach enshrined in Union law to the recognition of their results regardless of the frequency of inspections.

The application of a risk-based approach will enable pharmaceutical manufacturers to optimize processes and achieve stability and reliability in drug production by reducing risk. It will also save financial resources associated with receiving inspection teams.

The document shall enter into force on November 16, 2025. In accordance with the second paragraph, this document shall enter into force 30 calendar days after the date of its official publication. Published on the official website of the EAEU on October 17, 2025.

Link: https://eec.eaeunion.org/

October 17, 2025

Rospotrebnadzor has prepared a list of criteria for blocking domain names and pages on websites with prohibited dietary supplements

Draft order of Rospotrebnadzor “On approval of criteria for evaluating information necessary for the Federal Service for Supervision of Consumer Rights Protection and Human Welfare to make decisions that are grounds for including domain names and/or website page indexes in the Internet information and telecommunications network with regard to information containing offers for the retail sale of biologically active supplements, including by remote means, the retail sale of which is prohibited in accordance with the legislation of the Russian Federation on the quality and safety of food products” was submitted for public discussion on October 14, 2025 (published on the Federal Portal of Draft Regulatory Legal Acts).

This document contains a list of five grounds for including Internet pages that disseminate such prohibited information in the Unified Register of Prohibited Sites.

According to the draft order, the basis for deciding to block a domain name or website will be the presence of at least one of the following criteria:

– the presence of information containing an offer to retail biologically active supplements, including by remote means, that have not undergone state registration;

– the presence of information about the content of prohibited substances in biologically active supplements in accordance with the legislation of the Russian Federation;

– the presence of information about the content of regulated substances in biologically active supplements in quantities that do not comply with the values established in accordance with the legislation of the Russian Federation;

– the presence of information containing an offer to sell biologically active supplements, including remotely, under the guise of food supplements;

– the absence of reliable information about biologically active supplements, including information about the manufacturer (seller), as required by the legislation of the Russian Federation.

It should be noted that the procedure for extrajudicial blocking of websites with illegal dietary supplements was introduced by Law No. 150-FZ of June 7, 2025, which came into force on September 1, 2025.

It is planned that the order with the list of criteria will come into force on March 1, 2026, and will remain in effect until March 1, 2032.

Link: https://regulation.gov.ru/projects/161252/

http://publication.pravo.gov.ru/Document/View/0001202506070026

October 16, 2025 г.

Ministry of Industry and Trade develops procedure for issuing certificates on stages of drug production in the EAEU

On October 1, 2025, a draft order of the Russian Ministry of Industry and Trade was published on the official portal for draft regulatory legal acts “On the approval of the procedure for issuing and the form of a document containing information on the stages of the technological process of manufacturing medicinal products for medical use carried out on the territory of the Eurasian Economic Union,” developed in accordance with clause 10.2 of Article 5 of Federal Law No. 61-FZ of April 12, 2010 No. 61-FZ “On the Circulation of Medicinal Products” and paragraphs 5.2.18(39) and 5.8.20 of the Regulations on the Ministry of Industry and Trade of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 438 of June 5, 2008 “On the Ministry of Industry and Trade of the Russian Federation.”

The draft order proposes to approve the procedure for issuing and the form of a certificate containing information on the stages of the technological process of manufacturing medicinal products for medical use carried out on the territory of the Eurasian Economic Union (EAEU).

This document will be issued in accordance with the administrative regulations of the Ministry of Industry and Trade of the Russian Federation. The package of documents and the application must be submitted electronically via the Gosuslugi portal. The application must detail the stages of the technological process, guided by the classifier provided in the annexes to the draft. The certificate is valid for three years.

The basis for suspending the processing of an application will be the indication of the number of the electronic document from the labeling monitoring system to which several material balances are linked. In such a situation, consideration will be suspended for a period of up to 15 working days, and the suspension period will not be counted towards the total period for making a decision on the provision of the document.

The application will be returned without consideration if the files sent through “Gosuslugi” are damaged or contain irreparable technical errors that make them unreadable.

Link: https://regulation.gov.ru/projects/160818/

October 6, 2025

The list of medical goods whose sale and import into Russia is not subject to VAT has been clarified

On October 1, 2025, Resolution of the Government of the Russian Federation No. 905 dated June 17, 2025 came into force, introducing changes to the list of medical goods whose sale in the Russian Federation and import into the Russian Federation and other territories under its jurisdiction are not subject to (exempt from taxation) value added tax, approved by Resolution of the Government of the Russian Federation No. 1042 dated September 30, 2015.

The lists of medical devices related to probing and bougiening instruments, measuring devices for functional diagnostics, devices for replacing the functions of organs and body systems, and prostheses (implants for exoprosthetics and orthopedic fixation systems were added to the list) were expanded.

The clarifications also concerned lenses for vision correction and clothing for persons with disabilities with special needs.

Link: http://publication.pravo.gov.ru/document/0001202506170025

October 1, 2025