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The microbiological laboratory of LLC “BioJet” successfully passed the inspection by Rospotrebnadzor experts
Read more: The microbiological laboratory of LLC “BioJet” successfully passed the inspection by Rospotrebnadzor expertsAs a result of the inspection, the laboratory received a positive Sanitary and Epidemiological Conclusion and a license from Rospotrebnadzor for working with microorganisms of III-IV pathogenicity groups.
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“Geropharm” receives another compulsory license for semaglutide
Read more: “Geropharm” receives another compulsory license for semaglutideThe Russian government has granted Geropharm permission to use, without the patent holder’s consent, a portfolio of patents protecting Novo Nordisk’s exclusive rights to semaglutide until the end of 2025. Similar decisions had previously been made for two other Russian companies — PSK Pharma and Promomed — in late 2024. Geropharm had already been covered…
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Bill on penalties for “medication intoxication” while driving passes first reading
Read more: Bill on penalties for “medication intoxication” while driving passes first readingOn Tuesday, the State Duma passed in the first reading a government-sponsored bill introducing administrative liability for drivers who operate vehicles under the influence of certain medications. Bill No. 379447-8 proposes amendments to Articles 12.8 and 12.27 (Part 3) of the Russian Code of Administrative Offenses (KoAP), expanding the scope of punishable intoxication. Under the…
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FAS to investigate Russian pharmaceutical market over rising drug prices
Read more: FAS to investigate Russian pharmaceutical market over rising drug pricesThe Federal Antimonopoly Service (FAS) of Russia plans to investigate several domestic pharmaceutical companies due to signs of unjustified price increases for drugs not included in the list of vital and essential medicines (VED). This was announced by Timofey Nizhegorodtsev, Deputy Head of the FAS, during the Semashko Russian Pharmaceutical Forum. “Many companies may soon…
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Russia develops compounds capable of significantly suppressing tumor cell growth
Read more: Russia develops compounds capable of significantly suppressing tumor cell growthThe discovery could greatly reduce chemotherapy toxicity and change future approaches to cancer treatment. Scientists at Ural Federal University (UrFU) have created carbene-based platinum complexes that suppress tumor cell growth ten times more effectively than cisplatin — one of the most widely used chemotherapy drugs. The discovery could help fight tumors that have developed resistance…
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“Genealogical Extract”: Pharmaceutical Industry Discusses Mechanisms for Defining Manufacturing Nationality
Read more: “Genealogical Extract”: Pharmaceutical Industry Discusses Mechanisms for Defining Manufacturing NationalityAt the Semashko Russian Pharmaceutical Forum, domestic and international pharmaceutical companies gathered to discuss fair mechanisms for determining the level of localization in drug manufacturing and what support measures could help the industry invest more in development. Russia’s Ministry of Industry and Trade (Minpromtorg), the sector’s key regulator, reminded participants that it is currently working…
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FMBA approves procedures for medical and sanitary measures in emergency response
Read more: FMBA approves procedures for medical and sanitary measures in emergency responseThe Federal Medical and Biological Agency of Russia (FMBA) has approved the Regulations for organizing and conducting medical and sanitary activities aimed at the prevention, containment, and elimination of the consequences of emergencies (EMEs) related to radiation, chemical, and biological incidents. These activities will be carried out by the functional subsystem of medical and sanitary…
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Ministry of Health clarifies procurement procedure for medical products under the “second extra” rule
Read more: Ministry of Health clarifies procurement procedure for medical products under the “second extra” ruleThe Department for the Regulation of Drug and Medical Device Circulation of Russia’s Ministry of Health has issued a clarification in response to a request from the Krasnodar Territory’s Contract System Regulation Department. The clarification explains how to apply Government Decree No. 1875, dated December 23, 2024, which extends the “second extra” mechanism to purchases…
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Regulator prepares pricing rules for foreign drugs intended for individual patients
Read more: Regulator prepares pricing rules for foreign drugs intended for individual patientsThe Russian Ministry of Health has published a draft government decree outlining the pricing rules for unregistered foreign medicines imported into Russia for providing medical care based on vital indications for specific patients. These medicines must have international nonproprietary names (INNs) listed in the vital and essential drugs (VED) list. If adopted, the document will…
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Cabinet simplifies registration of maximum selling prices for essential medicines
Read more: Cabinet simplifies registration of maximum selling prices for essential medicinesThe government explained that this decision will accelerate the introduction of medications to the market and help avoid drug shortages and supply disruptions in pharmacies, clinics, and hospitals. Russian Prime Minister Mikhail Mishustin has signed a decree simplifying and speeding up the procedure for registering and re-registering the maximum selling prices for medications included in…