The final of the annual All-Russian competition for court battles and public speaking, the Kutafin Legal Cup, will be held on November 15 at the O.E. Kutafin Moscow State Law University (MSAL).

It is a particular honor for us to curate the Pharmaceutical Law track - an area in which we possess deep practical expertise.

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.

Lidings is pleased to invite you and your colleagues to a seminar on launching new drugs in the Russian market.

Regulatory incentives and objective economic realities are driving pharmaceutical companies to seek opportunities for launching new drugs. Such projects are now being conceived and implemented not only by innovative companies but also by players who have traditionally specialized in generics and biosimilars.

During our seminar, we will share our experience and propose effective, cost-efficient legal solutions to help businesses safely and promptly execute new launches at any stage.

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.

The new review of the most notable patents disputes in Life Sciences in EAEU and CIS.

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