The Russian government has approved an updated list of strategically important medicines
On April 29, 2026, a new list was published, comprising 206 items. These medicines address the healthcare system’s key needs in the prevention and treatment of the most dangerous and socially significant diseases. Order No. 942-r of April 23, 2026, was signed by the Chairman of the Russian Government.
The list includes:
- essential and critical medicines (ECM);
- vaccines included in the national immunization schedule and the schedule for vaccination based on epidemic indications;
- blood products, blood substitutes, and infusion solutions;
- narcotic analgesics;
- medications for the treatment of particularly dangerous infections and diseases that pose a threat to others.
All drugs on the list must be produced entirely within Russia. The government will provide support to companies that manufacture these drugs. In addition, these drugs will be given priority in government procurement.
These measures are aimed at strengthening the country’s pharmaceutical independence, ensuring a stable supply of medicines to healthcare facilities, and developing the export potential of the domestic pharmaceutical industry.
The document takes effect on April 27, 2026.
Link: http://publication.pravo.gov.ru/document/0001202604270047
April 29, 2026
The Russian government has approved quality and efficacy criteria for dietary supplements, taking into account their impact on human health
The relevant Resolution No. 398, dated April 13, 2026, was published on the official legal information portal on April 23, 2026.
For a dietary supplement to be recognized as high-quality, all four of the following conditions must be met simultaneously:
- the manufacturer holds a valid certificate of state product registration;
- the dietary supplement is labeled with identification marks, and information about it has been entered into the monitoring system;
- safety indicators and the content of active ingredients comply with the technical documentation, as confirmed by an accredited Russian laboratory;
- the product meets the requirements of the technical regulations of the Eurasian Economic Union (EAEU).
In addition, the document establishes criteria for the efficacy of dietary supplements based on the extent of their effect on the body. One of three approaches may be used to confirm efficacy:
- publications in scientific journals;
- the inclusion of information on the use of dietary supplements in current clinical guidelines;
- the manufacturer’s provision of its own data on studies of the supplement’s efficacy.
Effective Date – 01.05.2026.
Link: http://publication.pravo.gov.ru/document/0001202604230044
April 23, 2026
The EEC Council has postponed the launch of the single market for veterinary drugs by three years
The Council of the Eurasian Economic Commission (EEC) has approved amendments to the rules governing the circulation of veterinary medicines within the Eurasian Economic Union (EAEU). The relevant EEC Council Decision No. 33 of February 24, 2026, has been published on the EAEU legal portal.
The amendments are being made to EEC Council Decision No. 1 of January 21, 2022, which introduced uniform standards for the veterinary drug market. The key change is the extension of the transition period from 2027 to 2030.
By the end of 2030:
- Manufacturers may register veterinary drugs in accordance with national regulations;
- Registration certificates issued prior to the introduction of uniform standards remain valid;
- Companies are required to bring the dossiers for previously registered drugs into compliance with EAEU requirements.
If the rights holder fails to submit an application to update the dossier by the specified deadline, their registration (including indefinite registration) will be revoked as of January 1, 2031 (previously, as of 2028).
The option to conduct pharmaceutical inspections both in person and remotely is being introduced. Remote inspections are permitted in the following cases:
- the threat of, or response to, emergencies, natural disasters, man-made disasters, and epidemics;
- force majeure or other circumstances beyond the parties’ control that may endanger the life or health of the inspectors (e.g., political or medical risks).
The changes also affect Good Manufacturing Practice (GMP) certificates. Certificates issued by national authorities before January 1, 2021, will now remain valid until the end of 2028.
The procedure for replacing GMP certificates has also been regulated. They may be replaced without a new inspection in the event of a change in the manufacturer’s name or address, as well as in the event of technical errors. The new certificate will remain valid until the expiration of the previous one, and the decision to replace it is made within 10 business days.
Date of Publication of ECE Council Decision No. 33: March 25, 2026
Date of Entry into Force: April 24, 2026
Link https://docs.eaeunion.org/documents/461/10590/
April 14, 2026
The Russian government has approved the timeline for implementing mandatory labeling for an expanded list of medical devices
Russian Federation Government Resolution No. 375 of April 6, 2026, published on the official legal information portal, amends the previously effective document No. 894 of May 31, 2023.
Under the new rules, effective September 1, 2026, mandatory labeling will apply to the following types of medical devices:
- hearing aids;
- orthopedic shoes and insoles;
- incontinence products;
- medical gloves.
In addition, the list includes:
- respiratory equipment;
- incubators for newborns;
- syringes and infusion sets;
- medical wipes and test tubes;
- implants for plastic surgery;
- medical masks.
In the final version of the resolution, condoms—which had been included in the draft document—were removed from the list.
The pilot program for labeling certain medical devices began on September 1, 2024, and was originally scheduled to end on August 31, 2025. It covered, among other items, syringes, fillers, infusion sets, test tubes, and medical masks. In August 2025, the pilot program was extended until the end of February 2026.
The document also specifies that the registration of participants in the pilot program within the monitoring system will automatically be recognized when mandatory labeling is implemented. However, if a participant’s data is incomplete or out of date, it must be updated by September 30, 2026.
Effective from April 6, 2026, to September 1, 2026, pursuant to Russian Federation Government Resolution No. 375.
Link: http://publication.pravo.gov.ru/document/0001202604070004
April 13, 2026
The Board of the Eurasian Economic Commission has approved guidelines for the inspection of medical device manufacturing
On April 10, 2026, EEC Board Recommendation No. 6 of April 7, 2026, “On Methodological Guidelines for Inspecting the Production of Medical Devices,” was published. It is intended to standardize approaches to the assessment of manufacturers’ quality management systems (QMS) within the Eurasian Economic Union (EAEU).
As part of the inspection, special attention is paid to the following key processes:
- product design and development;
- document control;
- manufacturing operations and final quality control;
- implementation of corrective and preventive actions;
- interaction with customers and handling of customer inquiries.
The guidelines also establish criteria for identifying “critical” suppliers.
For Class 3 (highest) risk medical devices, inspection of design processes is not possible if the manufacturer does not conduct the relevant design activities. For Class 1, 2a, and 2b devices in a similar situation, inspection is permitted only on the basis of available technical documentation.
Link: https://docs.eaeunion.org/documents/462/10612/
April 10, 2026
The EEC Board has updated the lists of narcotic drugs, psychotropic substances, and their precursors
The Board of the Eurasian Economic Commission has updated the list of narcotic drugs, psychotropic substances, and their precursors that are subject to a licensing procedure for import and/or export into the customs territory of the Eurasian Economic Union (approved by Decision No. 30 of the EEC Board dated April 21, 2015).
The EEC made this decision taking into account that the EAEU member states, as parties to three international conventions, contribute to achieving the goal of protecting the health and well-being of the population. These are the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971, and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.
Following the decisions of the Commission on Narcotic Drugs, certain substances already subject to international control have been added to the lists of narcotic drugs and psychotropic substances regulated within the EAEU.
The document was published on April 10, 2026
The decision will enter into force on May 10, 2026, 30 calendar days after the date of its official publication.
Links:
https://docs.eaeunion.org/documents/463/10610/
April 10, 2026
The Russian Ministry of Health has approved a new professional retraining program in clinical pharmacology
Order No. 152n of the Ministry of Health of the Russian Federation, dated March 3, 2026, established a standard continuing education program for professionals with advanced medical degrees. Previously, in October 2025, a draft of this order was submitted for public comment.
Training will be conducted in a face-to-face format, although the partial use of electronic and distance learning technologies is permitted. The total duration of the program is 576 academic hours. The draft previously specified 648 hours, but the final version was reduced by 72 hours by shortening the practical component.
The program consists of four training modules and a final assessment:
- General Clinical Pharmacology — 108 hours.
- Specialized Clinical Pharmacology — 216 hours.
- Clinical Practice — 216 hours.
- Emergency Medical Care — 30 hours.
- Final Assessment — 6 hours.
Upon completion of the program, participants will have acquired the following key competencies:
- advising physicians and patients on the selection and use of medications;
- monitoring the safety of drug therapy and participating in initiatives to reduce antibiotic resistance;
- analyzing the use of medications and evaluating their cost-effectiveness;
- organizing medication supply in healthcare facilities;
- participating in disease prevention and promoting a healthy lifestyle;
- maintaining medical records and organizing work processes;
- provision of emergency medical care.
The effective date of this document is April 13, 2026.
Link http://publication.pravo.gov.ru/document/0001202604020018
April 7, 2026
Author
Dmitriy Kovalev
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