On 27 November 2025, Decree of the Government of the Russian Federation No. 1894 “On the Approval of the Rules for Coordinating with the Federal Security Service of the Russian Federation the Participation of Foreign...” (hereinafter referred to as the “FSB Coordination Rules”) was published. It stipulates that civil-purpose scientific research, experimental design, and technological work (hereinafter referred to as “Work”) involving foreign citizens and foreign organizations, as well as Russian organizations whose participants (founders) include foreign citizens and/or foreign organizations, must be coordinated with the FSB in the fields of scientific and/or scientific-technical activities and experimental development. This coordination is carried out by submitting information to the Russian Ministry of Science and Higher Education through the Unified State Information System for Accounting of Research, Development, and Technological Work (EGISU NIOKTR).

On 24 November 2025, the Delhi High Court issued a judgment in a major patent dispute Medilabo Rfp Inc. v. The Controller of Patents C.A. (Comm.Ipd-Pat) 16/2024, concerning the patent eligibility of a drug for neurodegenerative diseases.

In June 2024, the pharmaceutical industry faced a new practice by the Federal Antimonopoly Service (FAS), which began to consistently recognize the introduction of generic drugs onto the market as unfair competition.

On 17 November 2025, the Russian Ministry of Health published the Order No. 669n (hereinafter - the "Order") approving the procedure for healthcare professionals to prescribe dietary supplements when providing medical care to citizens.

Currently, the efforts of state authorities in the fields of pharmaceuticals and healthcare are also aimed at implementing the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the Period up to 2030 (hereinafter referred to as the “Pharma 2030 Strategy”). One of the goals of the Pharma 2030 Strategy is to increase the share of domestically produced medicinal products in the total consumption volume from 61.8% to 66.6% by 2030. In this regard, measures to support Russian medicinal products manufacturers continue to be implemented.

On 1 September 2025, a draft resolution of the Government of the Russian Federation “On approving the procedure and criteria for compiling a list of strategically significant medicines” (“Draft Resolution”) was submitted for public discussion.

On July 11, 2025, a joint letter from the FAS and the Ministry of Health № ТН/61566/25, № 25-7/И/2-13136 dated July 2, 2025 (hereinafter referred to as the "Joint Letter") was published, clarifying the procedure for determining the initial (maximum) contract price (IMCP) in the procurement of pharmaceuticals.

Overview of changes in the sphere of information security and personal data (hereinafter referred to as the “PD”) that will affect the activities of organizations involved in the wholesale and retail trade of medicinal products. We remind you that starting from September 1, 2025, consents for PD processing must be stand-alone documents, separate from website Privacy Policies

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.