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BioJet LLC Obtains License for Pharmaceutical Production
Read more: BioJet LLC Obtains License for Pharmaceutical ProductionIn November 2025, the production facility of BioJet LLC in Pechatniki successfully passed an inspection by the Russian Ministry of Industry and Trade. Based on the results, the company was granted a License to manufacture medicinal pharmaceutical products. License registration number: L012-00102-77/03725316, issued on November 13, 2025.
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The average cost of bringing a medicinal product to market has tripled over 20 years
Read more: The average cost of bringing a medicinal product to market has tripled over 20 yearsOver the past 20 years, the average cost of bringing a medicinal product to market has increased approximately threefold, reaching $2.5 billion, while the probability of success for an individual molecule at the late stages of clinical trials, according to Morgan Stanley estimates, has remained at just 8–12%. Against this backdrop, the traditional R&D model…
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More than 60% of the Russian pharmaceutical market is occupied by foreign drugmakers
Read more: More than 60% of the Russian pharmaceutical market is occupied by foreign drugmakersDespite sanctions and expectations of a complete withdrawal of foreign businesses, international pharmaceutical companies continue to hold key positions in the Russian medicines market. Based on the results of the first ten months of 2025, they account for more than 60% of sales in value terms and 36.9% in volume. International presence is especially pronounced…
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The Ministry of Industry and Trade will align the regulatory framework with the transition to EAEU GMP
Read more: The Ministry of Industry and Trade will align the regulatory framework with the transition to EAEU GMPThe Ministry of Industry and Trade of Russia has prepared a draft government resolution proposing that, as of March 1, 2026, certain provisions of regulatory acts granting the ministry authority to confirm compliance of pharmaceutical manufacturers with Good Manufacturing Practice (GMP) requirements under national rules be declared invalid. This is another step toward formalizing the…
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WHO Director-General: Pandemic agreement to be opened for signature after May
Read more: WHO Director-General: Pandemic agreement to be opened for signature after MayWHO member states are negotiating an important annex to the agreement — a pathogen access and genetic information-sharing system, said Tedros Adhanom Ghebreyesus. The pandemic agreement may be opened for signature after the 79th session of the World Health Assembly, which will be held in Geneva from May 18 to 23. This was announced by…
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The Ministry of Industry and Trade proposes extending transition periods related to confirmation of the country of origin of medicines and a number of medical devices
Read more: The Ministry of Industry and Trade proposes extending transition periods related to confirmation of the country of origin of medicines and a number of medical devicesRelevant draft amendments to resolutions of the Government of the Russian Federation*, prepared by the Ministry of Industry and Trade of Russia, have been published on the regulation.gov.ru portal.** The proposed changes предусматривают, for the purposes of obtaining support measures in public procurement, extending until June 30, 2026 the possibility to confirm the country of…
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MedSafetyWeek Global Pharmacotherapy Safety Week Launched Worldwide
Read more: MedSafetyWeek Global Pharmacotherapy Safety Week Launched WorldwideThe Russian Federation supports the initiative of the Uppsala Monitoring Centre of the WHO (UMC) and participates in the annual awareness campaign dedicated to the safe use of medicines — MedSafetyWeek. Traditionally held during the first week of November, national regulatory authorities from 117 countries worldwide encourage healthcare professionals, pharmacists, and patients to report adverse…
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Government to Review Draft Law on Improving Medicine Imports under Sanctions
Read more: Government to Review Draft Law on Improving Medicine Imports under SanctionsThe Russian government will consider a draft federal law “On Amending Article 47 of the Federal Law ‘On the Circulation of Medicines’” at a meeting on Thursday, according to the government press service. “The bill is aimed at improving the legal regulation of relations concerning the import of medicinal products for medical use into the…
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Russia to Complete Transition to EAEU GMP Rules by March 2026
Read more: Russia to Complete Transition to EAEU GMP Rules by March 2026The Russian government has recognized the national rules for inspecting pharmaceutical manufacturers for compliance with Good Manufacturing Practice (GMP) as invalid. In addition to three government resolutions related to GMP certification, clause 36 of the state services list — concerning the inspection of pharmaceutical companies producing medicines outside Russia — will also be repealed. The…
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Government Updates Rules for State Control in the Circulation of Medicines
Read more: Government Updates Rules for State Control in the Circulation of MedicinesThe Russian government has approved amendments developed by the Ministry of Health to the Regulation on Federal State Control (Oversight) in the Circulation of Medicinal Products. The document abolishes scheduled inspections for entities classified as significant, medium, or moderate risk, and sets the frequency of preventive visits based on risk category. The regulation also establishes…