On September 1, 2025, Federal Law No. 150-FZ dated June 7, 2025, 'On Amendments to Certain Legislative Acts of the Russian Federation' (hereinafter referred to as 'Federal Law No. 150'), will come into force, introducing a number of changes affecting the regulation of dietary supplements.

On 23 July 2025, a part of the Good Clinical Practice Guideline, GCP E6 (R3), promulgated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) comes into force. The development of new technologies, the rapidly evolving clinical trial (CT) ecosystem, and the need to respond quickly to deviations in CT processes have prompted the revision of the current version of GCP ICH E6(R2), which is valid until 22 July 2025.

On 6 May 2025, the updated version of the Order of the Ministry of Health dated 9 February 2016 No. 80n “On the Approval of the Procedure for Maintaining the State Register of Medicines for Medical Use” (the “Order”) came into force. The amendments were made in accordance with Order of the Russian Ministry of Health dated 17 March 2025 No. 129n, officially published on 25 April 2025.

The Eurasian Economic Union has published on its official legal website the Order No. 34 dated 08.04.2025 approving the draft decision on the extension of temporary measures related to specifics of medicines circulation in connection with special economic measures (“Draft Decision”).

A draft 02/08/02-25/00154538, which is intended to update a procedure for the establishing and functioning of a medical panel in healthcare organisations (“Draft”), has been placed on the Federal Portal of Draft Regulatory Legal Acts.

On 4 February 2025, the official portal of legal information were posted:

1. Order of the Ministry of Health No. 708n of 23 December 2024 “On Approval of the Procedure for Maintaining the Register of Issued Permits to Conduct Clinical Trials of Pharmaceuticals” (“Order No. 708n”) - the document replaces Order of the Ministry of Health No. 754n dated 26 August 2010;
2. Order of the Ministry of Health No. 706n dated 20 December 2024 establishing the procedure for the Ministry of Health to publish on its website a list of medical organisations conducting clinical trials (“Order No. 706n”) - the document replaces Order of the Ministry of Health No. 752n dated 26 August 2010.

Both documents entered into force on 15 February 2025 and aim to harmonise with the provisions of the EAEU regulations, as well as to simplify the system of information resources maintenance by the Ministry of Health by abolishing the “paper” document flow.

On 19 December 2024, the competent committees of the Federation Council of the Russian Federation approved Bill No. 670471-8 "On Amending the Criminal Code of the Russian Federation (in terms of clarifying liability for certain crimes against minors and against public health)" (hereinafter - the “Bill”).

On November 22, 2024, the Government of the Russian Federation (the “Government”) approved Resolution No. 1607 dated November 22, 2024 (the “Resolution”) on the experiment in the territory of the Russian Federation to conduct monitoring of Russian manufacturers of goods which are subject to mandatory marking with means of identification using the state information monitoring system for the circulation of goods subject to mandatory marking with means of identification (the “Experiment”).

More in our update.

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator's position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.

On 1 September 2024, a joint order of the Ministry of Industry and Trade No. 3554 and the Ministry of Health No. 406n dated 7 August 2024 (hereinafter referred to as the “Order”) entered into force, approving a new procedure for providing the Ministry of Industry and Trade with information on medicines necessary for the purposes of licensing their production and inspecting the subjects of their circulation for compliance the requirements of good manufacturing practice. The Order replaced the previously existing procedure for interdepartmental interaction between the Ministry of Health and the Ministry of Industry and Trade.