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FDA Introduces Draft Guidance on Accelerated Drug Approval Program
Read more: FDA Introduces Draft Guidance on Accelerated Drug Approval ProgramThe U.S. Food and Drug Administration (FDA) has published a draft guidance document for its Accelerated Approval Program, designed to expedite the approval process for new drugs. The guidance outlines criteria for two types of endpoints considered for accelerated approval: surrogate and clinical endpoints. Drugs approved under the Accelerated Approval Program must undergo additional confirmatory…
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Mishustin: 90% of Essential Medicines Should Be Produced in Russia
Read more: Mishustin: 90% of Essential Medicines Should Be Produced in RussiaAccording to the Prime Minister, this goal will be pursued as part of the national project “New Health Preservation Technologies.” The share of domestically produced medicines from the list of essential and vital drugs (EVDL) in Russia should increase to 90% by 2030, Russian Prime Minister Mikhail Mishustin announced. He noted that this effort will…
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Around 70% of Pharmaceutical Substances in Russia Are Imported
Read more: Around 70% of Pharmaceutical Substances in Russia Are ImportedImported 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
Read more: Russian Ministry of Health Proposes Updates to Drug Sampling Rules for State ControlThe 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
Read more: Russian Ministry of Health: 480 Drugs Registered Since the Beginning of the YearAccording 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
Read more: “R-Pharm” Receives Approval for Clinical Trials of Drugs for Hepatitis C and Breast CancerThe 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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The Lancet: Antibiotic Resistance Deaths to Surge by 2050
Read more: The Lancet: Antibiotic Resistance Deaths to Surge by 2050According 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
Read more: Ministry of Finance: The “Second Extra” Mechanism Will Be Extended to Vital and Essential Medicines and Strategically Significant MedicinesThe 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
Read more: Tested Drug Solutions: Clinical Trials of Medicines DecreaseAccording 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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Ministry of Health proposes expedited issuance of registration certificates for drugs not only in cases of defects
Read more: Ministry of Health proposes expedited issuance of registration certificates for drugs not only in cases of defectsMinistry 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…