According to the Russian Ministry of Industry and Trade, the volume of drug production has increased fourfold over the past 10 years, with two out of every three packages sold now produced domestically. Such rapid development demands equally swift and flexible regulatory adjustments. Key legislative changes, already in force or under consideration, were discussed at the RegLek-2025 research to practice conference. The GxP News editorial team has compiled the key takeaways from the event.
Making everything at home
There are now over 540 pharmaceutical manufacturers in Russia. Since 2010, more than 80 new production sites have opened in the country, 10 of them in the last 2 years alone. The market share of domestic medicines is growing steadily and has already reached 41% in value terms. In volume terms, the position of Russian producers remains consistently strong: two out of every three drug packages sold in the country are produced within the Russian Federation. As Ekaterina Shikina, Deputy Director of the Department of Pharmaceutical and Medical Industry Development at the Russian Ministry of Industry and Trade, stated at the “RegLek-2025” conference: “Strengthening the share of domestic products on the market is the result of joint work by both manufacturers and the state. In total, over 700 billion rubles have been invested in the industry by manufacturers, including state-supported investments of about 130 billion rubles.”
The rapidly changing market situation, active import substitution, and the need to launch innovations are also reflected in the sector’s regulatory policy. Legislation is adapting to the needs of business and society. For example, as Russia’s Deputy Minister of Health Sergey Glagolev stated at the forum, systems for conditional registration and accelerated review of socially essential drugs are now actively used. Over the past 3 years, about 20 innovative medicines have been registered via the conditional registration procedure, five of which are domestic developments.
Furthermore, last year, Russian Government Decree No. 385 authorized the research and production of biomedical cellular products. This document simplifies access to advanced cell-based therapies while ensuring the quality and safety of their application.
According to the Deputy Minister, one permit for the production and use of individualized cellular products has already been issued. The National Medical Research Center for Hematology (NMRC Hematology) of the Russian Ministry of Health became the first entity to receive a license to produce cell-based gene therapy drugs (CAR-T) at its own manufacturing site. The license allows them to initiate registration clinical trials for their in-house developed CAR-T cell product, effective against B-cell tumors carrying the CD19 surface antigen. The need for such drugs is significant, estimated at about 10,000 patients per year nationwide. Furthermore, the indications for CAR-T cell therapy are constantly expanding, as reported on the NMRC Hematology website.
“Another application for a permit to produce and use individualized biomedical cellular products is currently under review,” added Sergey Glagolev.
Common rules
However, the improvement of regulatory processes is not limited to national legislation. As Deputy Minister Glagolev noted, work is currently intensifying on registration within the EAEU (Eurasian Economic Union) standards and aligning national dossiers with unified Eurasian rules.
“We are currently seeing about 70% growth in the alignment of national drug registration certificates with EAEU norms,” he emphasized.
According to Chinara Mambetalieva, Deputy Director of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission, as of May 2025, over 31,500 registration applications had been submitted in total, with more than 10,500 registration certificates issued. “The Eurasian drug registration system is actively gaining momentum,” she agreed. For comparison: in 2023, there were only about 12,000 applications and 4,000 decisions issued.
Nevertheless, a number of manufacturers have not yet started aligning their dossiers with the common standard. This was highlighted by Valentina Kosenko, Acting Director General of the Scientific Center for Expertise of Medical Products of the Russian Ministry of Health. To allow everyone sufficient time to complete this, changes were made last year to the alignment procedure under EEC Council Decision No. 78.
“The updated provisions will come into force in June, and applicants will have the opportunity to submit documents until the end of this year to maintain their drug registrations, provided they correctly update their dossiers in accordance with Eurasian standards,” stated Sergey Glagolev.
And this is not the only change addressed in Decision 78. Also, instead of mandatory submission of a valid GMP certificate, it will be temporarily permitted to provide a package of documents confirming the initiation of the inspection process. However, the manufacturer must undergo the inspection within 3 years. Simultaneously, a new provision has been introduced stating that market circulation of a drug will be suspended if a valid GMP certificate is lacking and established deadlines are not met. As Glagolev emphasized, this innovation is designed to incentivize manufacturers to continuously comply with Good Manufacturing Practice (GMP) requirements.
Among the most significant anticipated innovations, he also highlighted the introduction of an orphan drug designation procedure in accordance with EAEU requirements, the standardization of developing pharmacopoeial articles common to the Union, and the improvement of drug expertise rules. For instance, expanding the possibilities for electronic interaction between applicants and the expert organization is planned. Furthermore, the Deputy Minister added, a resolution establishing updated rules for the importation of medicines into Russia is expected to be adopted soon, representing another step towards simplifying and digitalizing regulatory procedures.
