Press Center

On 16 October 2026, the Russian Government submitted to the State Duma bill No. 12837-9 (Bill) amending Federal Law No. 61-FZ dated 12 April 2010 "On Circulation of Medicines" (Law on Circulation of Medicines).

The Bill introduces a special circulation regime for individual gene therapy pharmaceuticals (IGTPs): a medical organisation will be able to manufacture such a pharmaceutical for a specific patient and use it on its own premises without registration, on the basis of an authorisation issued by the Russian Ministry of Health.

From 1 January 2027, a Patent Prosecution Highway (PPH) programme for patent applications for inventions filed with either of the two authorities will come into force in Russia and Belarus. It will apply, inter alia, to applications that have entered the national phase under the Patent Cooperation Treaty (PCT).

In 2025, the pharmaceutical market grew, and the number of transactions in it increased sharply. The high cost of borrowed capital, strict regulation and a valuation gap have made the legal structure of a transaction no less important than its price. The authors examine how Russian corporate law instruments work in the pharmaceutical industry — from the purchase of a pharmacy chain to a joint venture for product localisation.

On September 8, 2026, the Ministry of Health and Family Welfare of India published a draft amendment to the Drugs Rules from 1945, according to which a pharmacy must dispense any prescription drugs under video surveillance that records the dispensing, and keep the recordings for at least three months. For companies operating in both markets, it is important to take into account the difference in approaches. We cover this in more detail in our legal alert.

On 11–12 September, Sochi hosted the anniversary 10th Congress of Medical Device Industry Participants, organized by the LUSOMI Association.

Lidings Counsel and Head of Regulatory Practice Julia Kuzmenko gave a presentation titled “How to Build an Effective Barrier Against the Illegal Circulation of Medicines, Medical Devices and Dietary Supplements.”

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

• pdf, 5.00 Mb

On 1 July 2026, amendments to Resolution of the Government of the Russian Federation No. 719 of 17 July 2015 “On the Certification of the Manufacture of Russian Industrial Products” (hereinafter “Resolution No. 719”) came into force.

We invite you to a webinar on antitrust risks for pharmaceutical companies when setting prices for medicinal products.

As part of the implementation of the Strategy for the Development of the Pharmaceutical Industry through 2030, approved by Decree of the Government of the Russian Federation No. 1495-r of 7 June 2023 (“Pharma Strategy 2030”), and discussions at the “Healthy Society” forum organized by the Roscongress Foundation with the support of the Ministry of Health (16–17 March 2026, Moscow) (“Forum”), key areas of state support for domestic drug developers and manufacturers were identified, including subsidies for clinical trials .

In addition to existing support programs, subsidies for clinical trials at all stages will help overcome the financing barrier for high-risk phases of medicines clinical trials and accelerate the market launch of medicines. The combination of current and planned measures will create the legal and economic foundation for strengthening the production and technological capacity of the domestic pharmaceutical industry and increasing its presence in international markets.

Below, we will examine planned initiatives and support measures for pharmaceutical manufacturers that have already been implemented.