Ministry of Health, Roszdravnadzor, and NCESMP — areas of responsibility for medicines and what changed in 2025-2026
A regulatory manager receiving an inquiry from Roszdravnadzor about a drug’s composition or quality control methods often does not know where to turn. The registration dossier itself is stored at the Ministry of Health, the regulatory review was previously conducted by the Scientific Centre for Expert Evaluation of Medicinal Products (NCESMP), and the request arrived from a third agency. Three authorities are responsible for the same drug at different stages of its lifecycle, and confusion over where to direct a response costs companies weeks of overdue deadlines.
Over the past two years, interaction among these three agencies has shifted more noticeably than the allocation of their formal powers. A direct channel for data exchange was established between the Ministry of Health and Roszdravnadzor, including information protected as a commercial secret. Pharmacovigilance acquired new grounds for suspending a marketing authorization (MA). National treatment rules in public procurement became operational, with NCESMP acting as a key link for verifying production localization.
How Roles Are Distributed Between the Ministry of Health, Roszdravnadzor, and NCESMP
The Ministry of Health of Russia makes decisions on registering medicinal products, maintains the state register, and formulates state policy in this sphere. The Ministry approves the List of Vital and Essential Drugs (VED), licenses manufacturing, and represents Russia in the bodies of the Eurasian Economic Union (EAEU) as the authorized body for drug registration. Council Decision No. 78 of the Eurasian Economic Commission of November 3, 2016, «On the Rules of Registration and Examination of Medicines for Medical Use» (hereinafter — Decision No. 78) establishes this role. Separately from registration review, the Ministry oversees the ethical evaluation of clinical trials through the Ethics Council, which issues a conclusion on whether a trial may proceed before authorization is granted.
In 2025, the Ministry consolidated the departments previously responsible for medicines and medical devices separately. The new Department for Regulation of Medicines and Medical Devices Circulation comprises eight divisions, such as the Division of Drug Supply and the Division of Drug Registration.
NCESMP conducts the scientific and laboratory review on which the Ministry of Health bases its registration decisions. The Centre includes two testing facilities. The Testing Centre for Quality Evaluation of Medicines unites 13 laboratories and performs physicochemical, microbiological, and pharmaco-technological testing. The Testing Centre for Quality Evaluation of Medical Immunobiological Preparations works with vaccines, sera, and blood products across nine specialized laboratories and a vivarium. Together, both centers conduct over 10,000 tests per year.
The Centre is also responsible for the State Pharmacopoeia of the Russian Federation and for certifying the pharmacopoeial reference standards against which manufacturers verify the quality of their products.
Roszdravnadzor oversees what happens to a drug after registration. The Service conducts selective quality control of batches on the market, carries out pharmacovigilance, and operates the drug circulation monitoring system (MDLP), which tracks packages via Data Matrix codes. Roszdravnadzor Order No. 6720 of July 28, 2020, «On Approval of the Administrative Regulation of the Federal Service for Surveillance in Healthcare for Exercising Federal State Supervision in the Sphere of Circulation of Medicines» (hereinafter — Order No. 6720) sets the inspection procedure. If a manufacturer consistently demonstrates quality, the Service may move a drug from batch-by-batch selective control to routine selective control, based on positive test results across several consecutive batches.
| Body | Primary Role | Nature of Powers | Regulatory Focus |
|---|---|---|---|
| Ministry of Health of Russia | Regulator | Rulemaking, registration, state policy | Licensing, VED list, EAEU representation |
| NCESMP | Scientific arbiter | Regulatory review, laboratory analysis | Drug quality and safety, pharmacopoeia |
| Roszdravnadzor | Supervisory authority | Control, inspection, monitoring | Pharmacovigilance, selective control, MDLP |
What Changed in the Work of the Three Agencies in 2025-2026
Previously, during an inspection of a pharmacy or warehouse, a Roszdravnadzor inspector could find that a product’s composition or quality control method, recorded in the dossier, was out of reach because the originals were held in the Ministry of Health’s archive. Order No. 672n/6915 of the Ministry of Health of Russia and Roszdravnadzor dated December 6, 2024, «On Approval of the Procedure for Interagency Information Exchange for the Provision by the Ministry of Health of the Russian Federation to the Federal Service for Surveillance in Healthcare of Data on Medicinal Products» (hereinafter — Order No. 672n/6915) closed this gap.
Under the new procedure, Roszdravnadzor sends the Ministry of Health a request naming the drug and giving the details of the marketing authorization or registry entry and the list of documents needed. The Ministry registers and checks the request within one business day. The task then goes to NCESMP, which prepares the dossier information within three business days. The Ministry sends the material on to Roszdravnadzor within one further business day of receiving it. If the information is a commercial secret, the Ministry notifies the marketing authorization holder that it has been disclosed.
Roszdravnadzor Order No. 3518 of June 17, 2024, «On Approval of the Pharmacovigilance Procedure for Medicinal Products for Medical Use» (hereinafter — Order No. 3518) introduced a new procedure effective March 1, 2025. The Service gained grounds to suspend a drug’s marketing authorization (MA) if an expert body confirms the drug is dangerous, has an unfavorable benefit-risk balance, or is insufficiently effective, or if the MA holder has not met its pharmacovigilance obligations. Roszdravnadzor sends such a finding to the Ministry of Health within five business days of issuing it. Healthcare institutions must report serious adverse reactions to life-threatening drugs within three days.
Resolution No. 1875 of the Government of the Russian Federation dated December 23, 2024, «On Measures to Provide National Treatment in the Procurement of Goods, Works, and Services for State and Municipal Needs» (hereinafter — Resolution No. 1875) extended the «second superfluous» mechanism to procurement of VED-listed drugs from January 1, 2025. Under this mechanism, if at least one bid offers a drug of Russian or EAEU origin, all bids for foreign equivalents are rejected. From January 1, 2026, a similar rule took effect for Strategically Significant Medicines (SSMs) made through a full production cycle, including synthesis of the active substance. The date was originally set for September 1, 2025; Resolution No. 1326 of August 29, 2025, moved it to January 1, 2026, to give manufacturers time to launch a traceability system for pharmaceutical substances.
Drugs from EAEU member states without confirmed full localization are treated as foreign if at least one bidder in the procurement proves full-cycle production. NCESMP takes part in this process by reviewing substance quality to confirm the localization claimed.
| Parameter | Before | After |
|---|---|---|
| Data exchange (Ministry of Health-Roszdravnadzor) | Requests with no fixed timelines; restricted archive access | Unified procedure with fixed deadlines (1+3+1 business days) |
| Marketing authorization suspension under pharmacovigilance | Grounds not detailed under a unified procedure | Clear grounds, plus a 5-business-day deadline to forward findings to the Ministry of Health |
| «Second superfluous» rule for VED | Not applied | In effect since January 1, 2025 |
| «Second superfluous» rule for full-cycle SSMs | Not applied | In effect since January 1, 2026 |
What to Do
Clarify the request channel with the inspector. If Roszdravnadzor asks for dossier data, check whether the request was issued under Order No. 672n/6915. That channel comes with fixed deadlines and replaces informal correspondence between agencies.
Update your pharmacovigilance procedures for Order No. 3518. Confirm your team can meet the 3-day deadline for reporting serious adverse reactions, and that Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) are ready for submission in the new format.
Check your products’ status under the VED and SSM lists. This determines whether the «second superfluous» rule applies to a given procurement and what preferences are available to full-cycle competitors.
Gather full-cycle manufacturing proof in advance. Bidding on SSM procurement requires evidence of localization, including active substance synthesis, before the bid is submitted.
Check evaluation deadlines against Ministry of Health Order No. 558n. Quality evaluation of a pharmaceutical substance for market release takes no more than 30 business days; document review for clinical trial authorization takes no more than 25 business days. If a deadline slips, ask NCESMP for a status update directly.
The three agencies continue to divide responsibility along a drug’s lifecycle. The boundaries between them are clearer today than they were two years ago: data exchange between the Ministry of Health and Roszdravnadzor, marketing authorization suspension under pharmacovigilance, and the «second superfluous» rule all now come with fixed deadlines and defined grounds instead of open-ended uncertainty.
Regulatory Framework:
1. Federal Law No. 61-FZ of April 12, 2010, «On the Circulation of Medicines»
2. Eurasian Economic Commission Council Decision No. 78 of November 3, 2016, «On the Rules of Registration and Examination of Medicines for Medical Use»
3. Order of the Ministry of Health of Russia No. 558n of August 24, 2017, «On Approval of the Rules for Conducting Expert Evaluation of Medicines»
4. Order of Roszdravnadzor No. 6720 of July 28, 2020, «On Approval of the Administrative Regulation of the Federal Service for Surveillance in Healthcare for Exercising Federal State Supervision in the Sphere of Circulation of Medicines»
5. Order of the Ministry of Health of Russia and Roszdravnadzor No. 672n/6915 of December 6, 2024, «On Approval of the Procedure for Interagency Information Exchange for the Provision by the Ministry of Health of the Russian Federation to the Federal Service for Surveillance in Healthcare of Data on Medicinal Products»
6. Order of Roszdravnadzor No. 3518 of June 17, 2024, «On Approval of the Pharmacovigilance Procedure for Medicinal Products for Medical Use»
7. Resolution of the Government of the Russian Federation No. 1875 of December 23, 2024, «On Measures to Provide National Treatment in the Procurement of Goods, Works, and Services for State and Municipal Needs, and of Goods, Works, and Services by Certain Types of Legal Entities» (as amended by Resolution No. 1326 of August 29, 2025)