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FDA Introduces Draft Guidance on Accelerated Drug Approval Program
Read more: FDA Introduces Draft Guidance on Accelerated Drug Approval ProgramThe U.S. Food and Drug Administration (FDA) has published a draft guidance document for its Accelerated Approval Program, designed to expedite the approval process for new drugs.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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18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological Medicines
Read more: 18 Medical Organizations Granted Rights to Manufacture and Use Biotechnological MedicinesRussian Prime Minister Mikhail Mishustin has signed a document designating medical institutions authorized to produce and utilize biotechnological medicinal products (BTMPs). These are personalized drugs developed based on the unique genetic characteristics of each patient, representing a modern approach in gene and cell therapy. The official registry includes 18 leading medical organizations from various regions…
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Expert Explains the Features of Building a Pharmacovigilance System
Read more: Expert Explains the Features of Building a Pharmacovigilance SystemOccasionally, authorized bodies announce the need to update drug instructions. But how is it determined that an update is necessary? Who manages these processes within pharmaceutical companies and at the state level? Evgeniya Shapiro, General Director of “PSK Pharma,” provided insights into these and other questions. Do pharmaceutical manufacturers need to monitor the use of…
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Hedge Funds Seek Insights into Pharma
Read more: Hedge Funds Seek Insights into PharmaThe sharp rises and falls in pharmaceutical company stocks are prompting major hedge funds to hire doctors, scientists, and analysts to gain expert assessments of market prospects, Reuters reports, citing its sources. The year 2024 was marked by significant stock price fluctuations in pharma companies, driven by financial performance announcements and updates on various stages…
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Medicines to Be Exempt from “Visas”
Read more: Medicines to Be Exempt from “Visas”EAEU Countries Will Be Able to Recognize Drugs Registered by Other Member States Authorized agencies of the Eurasian Economic Union (EAEU) member states will have the ability to independently register medicines already introduced to the market in other member states, without the participation of manufacturers. This initiative, prepared by the Board of the Eurasian Economic…
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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…