News & Events
2026-06-05 10:00 Publication

Draft Law on Scientific Consulting for Pharmaceutical Industry submitted to the Russian State Duma

In April 2026, a draft law (ID 1215377-8) introducing amendments to the Federal Law “On Circulation of Medicines” No. 61-ФЗ dated 12 April 2010 (the “Federal Law No. 61”) was submitted to the State Duma. It extends and clarifies the existing framework for scientific consultations concerning the development of medicines.

Currently, scientific consultations regarding medicines for human use are regulated by Article 13(7) of the Federal Law No. 61 and the Order of the Russian Ministry of Health No. 343н dated 30 May 2019 (the “Order”). Under these rules, a pharmaceutical company may request a paid scientific consultation from the Ministry of Health.

The proposed amendments introduce significant changes to the current approach to scientific consultations. A comparison of the current and proposed legal frameworks is set out in the table below.
Comparison Criterion
Current version
Proposed version
Timing
Not specified
Prior to submitting an application for state registration of a medicine
Consulting scope
- pre-clinical and clinical studies; - assessment of quality, efficacy and safety; - state registration.
- analytical studies; - pre-clinical and clinical studies; - various aspects of state registration (in particular, issues relating to qualification and type of the application, sufficiency of the registration dossier, necessity of providing samples and other materials for testing, etc.)
Responsible organisation
Subordinate educational and scientific organisations (excluding the ones responsible for the assessment within a state registration procedure)
Expert organisation responsible for the assessment within a state registration procedure (most likely, it will be the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products”)
Consultants
Not defined
- certified experts having a relevant higher education; - other persons, subject to additional requirements to be established
Advice delivery
Written response only
- in-person consultation (minutes of the meeting are provided); - remote consultation (minutes of the meeting are provided); - written response
Impact on the state registration process
The advice is non-binding and does not predestinate further regulatory decisions
The advice is subject to inclusion into the registration dossier and shall be considered during the registration process
Publication of information
Basic information about consulting services, the content of requests and responses
Basic information about consulting services, summarised consulting results
If the draft law is adopted, the proposed amendments will come into force on 1 September 2026. The Ministry of Health will also issue regulatory acts on: (1) timing and procedure for consultations; (2) fees and payment procedures; and (3) categories of medicines eligible for priority consulting.

The extension of the consulting scope, the inclusion of the expert organisation in the consultation process, and the integration of its results into the registration dossier make the new framework of scientific consulting an attractive tool for mitigating regulatory risks at the market launch stage.

If adopted, we recommend that pharmaceutical companies strenghthen their regulatory strategies with the new form of scientific consulting, especially in respect of sensitive elements of the Russian drug pipeline.

*In Russian

Authors

Life Sciences & Healthcare practice of SL LEGAL advises on all issues related to the circulation of medicines, including their market launch in Russia and EAEU.