News Digest 26.12.2025 — 16.01.2026
Regulators
Russia Extends Simplified Procedure for Registration of Medicines and Medical Devices
Simplified procedures for state registration of certain medicines have been extended until January 1, 2036, and for the most in-demand medical devices until December 31, 2028. The Russian government decree is available on MV.
According to the Cabinet's press service, this decision will help maintain market stability in the face of external sanctions. The simplified registration procedure allows for the rapid processing of documents required to bring products to market, as well as avoiding shortages and supply disruptions to pharmacies, clinics, and hospitals.
A special interdepartmental commission will determine the list of medicines and medical devices eligible for registration under the simplified procedure. The Russian Ministry of Health has been instructed to amend orders for the registration of maximum selling prices for drugs included in the List of Vital and Essential Drugs (VED) valid until January 1, 2028, by December 27, 2027. Roszdravnadzor (Federal Service for Surveillance in Healthcare) is required to update the state register of medicinal products for medical use with information on changes to the validity periods of registration certificates by January 1, 2028. Roszdravnadzor (Federal Service for Surveillance in Healthcare) is required to update the state register of medical devices and manufacturing organizations with information on changes to the validity periods of registration certificates.
In October, the Russian Ministry of Health developed amendments to the Federal Law "On the Circulation of Medicines" and two government decrees aimed at extending the validity period of the simplified procedure for registering medicinal products and medical devices. This is intended to ensure the import and circulation of medicinal products registered in foreign countries in the Russian Federation in the event of a shortage or the risk of a shortage due to the imposition of restrictive economic measures against Russia.
Roszdravnadzor previously reported an increase in the number of citizen complaints regarding access to medicines and medical devices. This year, the number of such inquiries has increased by 18%, MV reported.
Transition to a single market for medical devices in the EAEU has been postponed for two years
The transition to a single market for medical devices has been postponed for two years; the EAEU countries have signed a protocol to this effect. Registration applications can be submitted until the end of 2027, and renewals can be made until 2028.
The formation of a single market for medical devices within the Eurasian Economic Union (EAEU) has been postponed for two years. These changes were made to the agreement between the union countries, according to a protocol published on the EAEU legal portal on December 29.
According to the protocol signed by the countries, the deadlines have been shifted as follows:
- the period for completing the harmonization of legislation and applying uniform rules for the circulation of medical devices has been extended to 2027 (previously 2025);
- the deadline after which national conformity assessment documents will cease to be valid within the union has been postponed to 2028 (previously 2026);
- the termination of import permits issued under national rules has been postponed until 2028.
The protocol will be provisionally applied ten days after signing, and its final entry into force will occur after all EAEU countries have completed the necessary domestic ratification procedures.
The Russian government previously approved a two-year postponement of the transition to uniform rules for the circulation of medical devices in EAEU countries.
Special Procedure for Circulating Medicines in Foreign Packaging Extended Until the End of 2027
At the end of December 2025, the Russian Government approved an amendment to its Resolution No. 593 of April 5, 2022, "On the Specifics of Circulating Medicines for Medical Use in the Event of a Shortage or Risk of a Shortage of Medicines in Connection with the Introduction of Restrictive Economic Measures Against the Russian Federation." The clause in the document affecting the regulations for circulating medicines in foreign packaging has been extended until the end of 2027. The amendments came into effect on January 1, 2026.
The government emphasized that this decision will maintain a stable supply of essential medications to pharmacies, clinics, and hospitals.
Government Resolution No. 593 was adopted in April 2022 to specify the special procedure for circulating medicines and medical devices in non-Russified packaging. This mechanism was provided for in amendments to Federal Law No. 61-FZ "On the Circulation of Medicines" dated March 2022. The import of drugs under this algorithm is permitted if they are defective or at risk of defectiveness. Drugs must meet all requirements established during registration, with the exception of those applicable to primary and secondary packaging. Consumer packaging must contain self-adhesive labels containing product information in Russian.
The initial version of Federal Law No. 61-FZ stipulated that this clause would remain in effect until the end of 2022; this date was later changed to December 31, 2024, and then to December 31, 2025. This provision was most recently extended at the end of 2025 until the end of 2027.
Resolution No. 593 was initially scheduled to remain in effect until December 31, 2023, but the government later extended it until the end of 2024. In addition to authorizing the sale of drugs in foreign packaging, the regulation established an expedited procedure for state registration and quality assessment of defective drugs. At the end of December 2024, regulators extended the validity of paragraph 593 of Resolution No. 593, which concerns the circulation of drugs in foreign packaging, through 2025. The remainder of the document was immediately extended until the end of 2027 by a separate government decree.
According to regulators, between 2022 and 2025, an interdepartmental commission issued decisions regarding defects or the risk of defects for 200 drugs, and for 14 of these, the agency granted approval for their circulation in Russia in packaging intended for foreign countries.
At the end of December 2025, the government also extended the validity of registration certificates and permits for the temporary circulation of defective drugs and medical devices issued under two documents—Resolutions No. 441 and No. 552—and extended the validity of these regulations until January 1, 2036, and December 31, 2028, respectively. The first contains specifics for the circulation of drugs intended for use in emergency situations, while the second simplifies the procedure for replacing raw materials and components in registered medical equipment and establishes fast-track validation for potentially defective products.
The EEC Council established a points system for localization of pharmaceutical products
The Eurasian Economic Commission (EEC) Council has established a points-based system for determining the localization of pharmaceutical products and certain medical devices. For some types of medical devices, the ability to declare the country of origin has been extended by six months and then by one year.
The Eurasian Economic Commission (EEC) Council has established a points-based system for determining the level of localization of pharmaceutical products and certain medical devices. Decision No. 117 of November 19, 2025, was published on the legal portal of the Eurasian Economic Union (EAEU).
The amendments are being made to EEC Council Decision No. 105 of November 23, 2020, "On Approval of the Rules for Determining the Country of Origin of Certain Types of Goods for the Purposes of Public (Municipal) Procurement."
According to the adopted document, for a product to be considered manufactured in the EAEU, the manufacturer must earn a certain number of points. For pharmaceutical products, the minimum threshold is 50 points. For certain types of medical devices, thresholds have been set between 70 and 350 points, which will gradually increase by 2029.
Furthermore, the validity period of simplified rules for certain medical products has been extended. For some medical devices, the ability to declare the country of origin under the old rules has been extended until June 30, 2026 (instead of the end of 2025), and for another group of products, until December 31, 2026.
In September 2025, the Russian Government approved a resolution according to which the level of localization of pharmaceutical products in Russia will be measured in points.
In December, the Russian Ministry of Industry and Trade proposed extending the transition periods related to confirming the country of origin of medicines. This initiative was developed in connection with the transition to a points-based system for assessing the country of origin of medicines and the launch of the "second wheel" mechanism for strategically important medicinal products (SLM). The entry into force of the country-of-origin scoring system for medicines has been postponed from January 1 to July 1, 2026.
The procedure for transferring data on AI-enabled medical devices to Roszdravnadzor is being prepared for reissue
The procedure for automatically transferring data on artificial intelligence-enabled medical devices (MD) to Roszdravnadzor expired on December 31, 2025. A draft of the new order, compliant with the registration rules for MDs in the EAEU countries, has been published on regulation.gov.ru. This document will replace Federal Service for Surveillance in Healthcare Order No. 4472 of July 21, 2025 (available on MV).
No significant changes are planned to the procedure. It was clarified that data must be transmitted both on the scope of application of AI-enabled medical devices and on the type of solution used for the medical device.
The document will take into account the new transition period for medical device registration in EAEU countries. The Russian government changed this deadline from December 31, 2026, to December 31, 2028, as reported by MV. The changes were made to Resolution No. 1684 of November 30, 2024, "On Approval of the Rules for State Registration of Medical Devices."
In 2025, medical device registration in Russia entered a new phase: AI-enabled automation has ceased to be simply a convenient addition and has become an effective tool for the controlled and accelerated acquisition of a registration certificate (RC). This is especially relevant given the growing volume of documentation and the increasing complexity of medical devices themselves, as well as stricter regulatory requirements.
Market news
The Federal Antimonopoly Service (FAS) has uncovered a 277-million-ruble cartel in procurement for Moscow medical institutions
The Federal Antimonopoly Service (FAS) of Russia has opened a case following tenders for the supply of medical products and consumables to Moscow healthcare institutions. According to the agency, the procurement participants may have acted in concert: signs of anticompetitive agreements were identified in 114 procurement procedures worth nearly 277 million rubles.
The defendants in the case include Katonika LLC, Vector-M LLC, Transformatsiya LLC, Remedix LLC, Medvet LLC, and two individual entrepreneurs. The possible collusion was identified, in part, using the state information system "Anticartel," which the FAS uses to analyze the behavior of bidders.
According to the agency's preliminary assessment, the total initial maximum contract prices for the disputed procurements amounted to 276.961 million rubles. If violations are confirmed, the parties to the case may be subject to administrative fines in accordance with the Russian Code of Administrative Offenses.
According to SPARK-Interfax, the companies involved in the antitrust case, with the exception of Transformatsiya LLC, intersected when participating in government procurement of medical devices and consumables for Moscow healthcare institutions. These included tenders for the supply of equipment and consumables for clinical diagnostic laboratories, including biochemistry, hematology, and coagulation analyzers, as well as reagents, calibrators, and control materials used in laboratory testing.
The procurement was conducted for medical organizations under the jurisdiction of the Moscow Department of Healthcare, including the city clinical hospitals named after S.S. Yudin and No. 29 named after N.E. Bauman, Psychiatric Clinical Hospital No. 1 named after N.A. Alekseev, War Veterans' Hospital No. 3, and the Endocrinology Dispensary of the Moscow Health Department.
Other
Natalya Kaspersky Warns of the Risks of Using a Federal Patient Registry
InfoWatch Group President and information security expert Natalya Kaspersky assessed the risks of creating a unified federal patient registry and plans to share sensitive medical information about patients included in it with the Russian Ministry of Internal Affairs. Widespread access to such databases creates the potential for leaks, resale on the darknet, and abuse.
The launch of a unified federal registry of patients with specific diseases and the sharing of this information with other agencies, particularly the Russian Ministry of Internal Affairs, creates a high risk of personal data leaks and abuse. The project's stated noble goals—collecting general medical statistics, freeing doctors from repetitive data entry, and supposedly "improving lives"—are realized by infringing on citizens' constitutional rights. Last year alone, more than 1.5 billion personal data records became publicly available, Natalya Kaspersky, President of the InfoWatch Group and Chair of the Board of the Association of Software Developers "Domestic Software," told Rossiyskaya Gazeta.
"The government decree and explanatory notes claim that the data will be protected, although the practice of leaks over the past few years shows the exact opposite. Hundreds of millions of records are constantly being leaked from government information systems. This is not only about protection, but also about the legal consequences for individuals who end up in such databases. Furthermore, there is a feeling that by enriching previously leaked information with this data, sensitive matters such as adoption confidentiality could be compromised," the expert emphasized.
According to her, general access to such databases should be considered a violation of medical confidentiality (Article 13 of Federal Law No. 323-FZ "On the Fundamentals of Health Protection...") and the individual's right to privacy. This is especially true when it comes to mental health conditions or pregnancy, which should be of no concern to the Russian Ministry of Internal Affairs and the Russian Ministry of Health. A person might suffer a severe nervous breakdown once, be seen by a psychiatrist, and then remain on the registry for the rest of their life, losing their driver's license, for example. Therefore, if a patient seeks help from a doctor for such a condition, or even a suspicion of one, they are automatically added to the registry. Importantly, there is no provision for deleting records from the registry.
"If this is needed for statistics, then why report the full name? Simply reporting the presence of the disease is sufficient. Furthermore, distributed databases could be used: the data is stored within the medical facility, and only aggregated figures for diagnoses and conditions are sent to the top. Instead, they are trying to create a single array of highly sensitive data, which will likely later surface on the darknet, be linked to other databases, and be used to foist drugs on quacks, scammers, and recruiters," she emphasized.
FMBA has submitted an application to register a birch pollen allergy vaccine
Russia will review the application to register the Allergard vaccine for birch pollen allergy. The drug demonstrated effectiveness even during an abnormally dusty season—a quarter of study participants did not react to the allergen.
The Federal Medical and Biological Agency (FMBA) has submitted an application to register the Allergard vaccine for the prevention of birch pollen allergy and cross-reactivity to food, Veronika Skvortsova, head of the agency, announced in an interview with the Rossiya 24 television channel.
Allergard was developed by the State Research Center of Immunology of the Federal Medical and Biological Agency. Phases I and II of the clinical trials have been completed. The vaccine's safety, good tolerability, and high efficacy have already been proven, the head of the Federal Medical and Biological Agency (FMBA) stated.
She recalled that the 2025 pollen season was abnormally high, with dust particle density exceeding the norm by five times. A quarter of the test subjects showed no reaction to these particles at all, despite typically suffering from severe allergies. The remaining subjects' reactions were six times reduced.
In August 2024, Veronika Skvortsova announced that preclinical studies for this vaccine had been completed and approval for clinical trials had been received. In June 2025, the head of the Federal Medical and Biological Agency (FMBA) called the clinical trial results "very encouraging."
During the 2024 St. Petersburg International Economic Forum (SPIEF), First Deputy Head of the Federal Medical and Biological Agency (FMBA), Tatyana Yakovleva, noted that this is the only drug of its kind in the world. The vaccine is expected to enter commercial circulation in 2026.
New registered medical devices
We publish a list of new medical devices registered from 12.26.2025 to 01.16.2026
Link to the list: [see table in the attachment]
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