Simplified procedure for registering medicines and medical devices extended
Government Resolution No. 2158 of December 26, 2025, on extending the simplified procedure for state registration of pharmaceutical products was published on December 30, 2025.
Terms of validity of the simplified procedure:
- for certain medicines — until January 1, 2036;
- for the most sought-after medical devices — until December 31, 2028.
The measure is aimed at maintaining stability in the pharmaceutical and medical device markets. The simplified procedure allows:
- significantly reduce the time required to obtain permits and licenses;
- quickly bring medicines and medical devices to market;
- prevent product shortages and supply disruptions to pharmacy chains, clinics, and hospitals.
A special interdepartmental commission compiles a list of drugs and medical devices subject to simplified registration. It includes representatives from:
- Ministry of Health;
- Roszdravnadzor (Federal Service for Supervision of Public Health and Social Development);
- Ministry of Industry and Trade;
- Ministry of Finance;
- Federal Antimonopoly Service;
- Federal Customs Service.
Link: http://publication.pravo.gov.ru/document/0001202512300034
December 30, 2025
The list of essential medicines has been expanded: eight new drugs have been added
Decree No. 3867-r of the Government of the Russian Federation dated December 18, 2025 approved the List of Essential and Vital Medicines for Medical Use.
The updated list includes eight medicines used for therapy:
- anemia;
- neutropenia;
- recurrent pericarditis;
- various malignant neoplasms.
New drug names have been added:
- capivasertib;
- camrelizumab;
- darolutamide;
- lorlatinib;
- luspatercept;
- pretomanid;
- pegfilgrastim;
- gofliccept.
The inclusion of drugs in the list of essential and vital drugs for medical use means:
- state regulation of prices for these drugs;
- the possibility of their use within the framework of the state guarantee program for the provision of free medical care to citizens.
As for the current composition of the list, at the time of the update, there are 827 drugs on the list of essential and vital medicines. At the same time:
- 666 items (80.5%) are produced in Russia;
- of these, either through the full cycle (including synthesis of the pharmaceutical substance) or starting from the finished dosage form stage.
Link: http://publication.pravo.gov.ru/document/0001202512240041
December 26, 2025 года
Draft resolution on expanding medical device labeling rules submitted for public discussion
A draft resolution of the Government of the Russian Federation “On Amendments to Resolution of the Government of the Russian Federation No. 894 of May 31, 2023” on expanding the rules for labeling medical devices was prepared and posted on the Federal Portal of Draft Regulatory Legal Acts on December 22, 2025.
Key changes provided for in the draft.
The document proposes to significantly expand the list of medical devices that must be labeled with identification means.
For each category of products, the draft specifies:
- a specific set of mandatory data to be entered into the national catalog;
- specific parameters (e.g., needle size or product composition).
In addition, additional requirements are being introduced for participants in the circulation of medical devices:
- mandatory transfer of detailed information about the location of operations to the monitoring system;
- the need to regularly update this information.
December 22, 2025
Draft methodological recommendations for inspecting the production of medical devices submitted for public discussion
The Board of the Eurasian Economic Commission (EEC) has prepared a draft recommendation on methodological guidelines for inspecting the production of medical devices. The purpose of the document is to develop unified principles for assessing manufacturers’ quality management systems (QMS). The assessment should be carried out in accordance with the Requirements approved by the EEC Council Decision.
The recommendations detail the inspection algorithm, taking into account the potential risk of using medical devices.
The methodological recommendations are systematized according to the key QMS processes to be assessed during the inspection: design and development; production and final inspection; documentation and record management; corrective and preventive actions; consumer-related processes.
Checklists have been developed for each of the processes listed. They contain specific tasks for inspectors and instructions for collecting objective evidence.
The draft separately elaborates on the criteria for selecting a representative project for inspection,
the procedure for identifying critical suppliers, and the specifics of evaluating individual processes.
The following are regulated in detail: the procedure for inspecting outsourcing operations (including sterilization); the methodology for assessing risk management at all stages of the product life cycle.
Inspection procedures vary depending on the risk class of the medical device and whether the manufacturer has a certified quality system.
Following the inspection, each item on the checklist must be recorded in the appropriate column. Completed and signed checklists are included in the draft inspection report (for subsequent approval) and stored by the inspection organization in accordance with internal document and record management rules.
Link: https://regulation.eaeunion.org/pd/3299/
December 17, 2025
A law has been passed to extend the import of medicines in foreign packaging
Federal Law No. 483-FZ “On Amending Article 47 of the Federal Law ”On the Circulation of Medicines” was published on December 15, 2025.
The amendments concern the duration of the special regime allowing the import and circulation in Russia of registered drugs in foreign packaging in the event of a defect or risk of a defect arising against the backdrop of sanctions (introduced by Decree of the Government of the Russian Federation No. 593 of April 5, 2022). The special regime was to remain in effect until December 31, 2025.
The amendments to Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicines,” extend until December 31, 2027, the permission to import into the Russian Federation and further circulate medicines in packaging intended for circulation in foreign countries, in the event of defects or the risk of defects during the period of restrictive economic measures imposed on the Russian Federation, provided that the imported medicinal products comply with the requirements established during their registration, with the exception of requirements for primary packaging, secondary (consumer) packaging, and provided that the secondary (consumer) packaging of medicines in circulation has a self-adhesive label containing information about the medicine in Russian.
Federal Law No. 483-FZ comes into force on January 1, 2026.
Link: http://publication.pravo.gov.ru/Document/View/0001202512150048
December 16, 2025
The rules for registering medicinal products have been changed
On November 26, 2025, the EEC Council adopted Resolution No. 93 “On Amendments to the Rules for the Registration and Examination of Medicinal Products for Medical Use.”
The document introduces a number of significant clarifications:
- details the sequence of stages of expert assessment;
- makes adjustments to the requirements for the preparation of registration dossiers;
leads to a uniform standard for the procedure for submitting documents for the approval of medicinal products in all member countries of the union.
The decision pays particular attention to the introduction of the concept of “confidential data.” This category includes information that constitutes a trade secret, including:
- technological aspects of production;
- results of verification activities;
- plans for bringing the drug to market;
- information about production facilities.
Developers will have the right to exclude such data from public versions of expert reports, which will allow them to reliably protect their commercial interests.
In addition, the amendments provide for a more detailed classification of the types of changes that can be made to an already registered dossier.
Link: https://docs.eaeunion.org/documents/447/10313/
December 5, 2025
The Ministry of Health has made changes to the list of drugs subject to itemized quantitative accounting
The Ministry of Health has expanded the list of medicines subject to strict itemized and quantitative accounting in pharmacies and medical institutions.
The changes were approved by Order of the Ministry of Health of Russia No. 653n dated October 28, 2025, “On Amendments to the List of Medicines for Medical Use Subject to Itemized and Quantitative Accounting, Approved by Order of the Ministry of Health of the Russian Federation No. 459n dated September 1, 2023.” (Registered with the Ministry of Justice of Russia on November 28, 2025, No. 84337).
Several new drugs will be included in the list, in particular, the drug Prasterone has been added to Section II for strict accounting, and new items have been included in a separate category in Section IV: Gabapentin (medicines), Baclofen (except for the dosage form for intrathecal administration), Dicycloverine+Paracetamol (medicines), as well as Misoprostol, Mifepristone, and Cyclopentolate.
The order comes into force on March 1, 2026, and is valid until September 1, 2030.
Link: http://publication.pravo.gov.ru/document/0001202511280024?index=1
December 1, 2025
Author
Dmitriy Kovalev
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