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Around 70% of Pharmaceutical Substances in Russia Are Imported
Imported active pharmaceutical substances (APIs) account for approximately 70-75% of the Russian market, according to Razia Solodova, head of the analytical center of the FBU “State Institute for Drugs and Good Practices” of the Russian Ministry of Industry and Trade. She presented these findings at the 26th International Exhibition of Equipment, Raw Materials, and Technologies…
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Russian Ministry of Health Proposes Updates to Drug Sampling Rules for State Control
The Russian Ministry of Health has proposed amendments to Decree No. 1049, dated June 29, 2021, which regulates state oversight in the circulation of pharmaceuticals. Public discussion of the proposal will continue until the end of November 2024. The draft document outlines detailed mechanisms for selecting organizations to conduct control measures for assessing drug quality.…
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Russian Ministry of Health: 480 Drugs Registered Since the Beginning of the Year
According to Russian Minister of Health Mikhail Murashko, approximately 480 drugs have been registered in the country since the start of 2024, with over 70% produced by domestic manufacturers. During the same period, Roszdravnadzor issued 1,800 registration certificates for medical devices, half of which are also of Russian origin. Murashko shared this information in his…
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“R-Pharm” Receives Approval for Clinical Trials of Drugs for Hepatitis C and Breast Cancer
The Russian Ministry of Health has granted “R-Pharm” permission to conduct clinical trials (CT) for generics of two drugs: the oncology drug Zenlistik (abemaciclib) from Eli Lilly and the hepatitis C treatment Mavyret (glecaprevir/pibrentasvir) from AbbVie. Both medications are protected by Eurasian patents in Russia until 2034 and 2033, respectively. The trials will take place…
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Validation 2.0: How the Market Has Changed After the Exit of Global Suppliers
Inspections of pharmaceutical companies for compliance with GMP/GAMP 5 requirements are becoming more complex and frequent. According to open data, in 2024 alone, 401 GMP inspections of drug manufacturers were conducted in Russia—twice as many as ever before. At the same time, Russian pharmaceutical manufacturers have lost access to global service providers and are now…
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The Lancet: Antibiotic Resistance Deaths to Surge by 2050
According to a study published in The Lancet, by 2050, bacteria resistant to existing antibiotics could cause over 39 million deaths and indirectly contribute to an additional 169 million deaths. The forecast predicts that without effective measures to combat this issue, annual mortality directly caused by antimicrobial resistance (AMR) could reach 1.91 million people, with…
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Ministry of Finance: The “Second Extra” Mechanism Will Be Extended to Vital and Essential Medicines and Strategically Significant Medicines
The Ministry of Finance of Russia has revised a draft decree that establishes the procedure for providing advantages to Russian pharmaceutical manufacturers over foreign ones in state procurement. According to the new document, updated procurement rules for medicines from the list of vital and essential medicines (VEM) and strategically significant medicines (SSM) will take effect…
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Tested Drug Solutions: Clinical Trials of Medicines Decrease
According to the results of the first half of 2024, the number of approved clinical trials necessary for the registration of new drugs in Russia has decreased by more than a quarter year-on-year. The number of trials conducted by local companies for generics, which have contributed to the pharmaceutical market’s growth for two consecutive years,…
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Regulatory Vocabulary. Industry Legal Acts of August 2024
The “Pharmaceuticals and Healthcare” practice of the law firm VERBA LEGAL, at the request of Vademecum, has prepared an overview of the regulatory legal acts (NPA) that came into force in August 2024, related to the circulation of drugs and medical devices. Additionally, the lawyers discussed some documents that took effect on September 1, 2024,…
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Ministry of Health proposes expedited issuance of registration certificates for drugs not only in cases of defects
Ministry of Health of Russia plans to amend the procedure for making changes to registration certificates for defective drugs, as outlined in Government Resolution No. 440 dated March 23, 2022. The agency considers it necessary to extend the legal act’s application to the registration process of drugs whose active substances are not produced domestically. In…