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Validation 2.0: How the Market Has Changed After the Exit of Global Suppliers
Read more: Validation 2.0: How the Market Has Changed After the Exit of Global SuppliersInspections 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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Russia to increase production of infliximab-based medicines
Read more: Russia to increase production of infliximab-based medicinesThe company “Pharmapark” plans to steadily increase its production volumes. Specifically, over 30,000 packages of infliximab-based medicines are expected to be introduced into civilian circulation in Russia by the end of 2025, according to TASS, citing the press service of the Ministry of Industry and Trade of Russia. Earlier, media reports highlighted a shortage of…
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A unified database for veterinary drugs will be launched in EAEU countries
Read more: A unified database for veterinary drugs will be launched in EAEU countriesThe Collegium of the Eurasian Economic Commission (EEC) has approved the creation of a unified database for animal drugs identified through state supervision. This database will include information about quality, substandard, counterfeit, and falsified veterinary drugs within the territory of the Eurasian Economic Union (EAEU) member states. New participants will join this process according to…
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MSD will pay up to $2 billion for Chinese heart medication
Read more: MSD will pay up to $2 billion for Chinese heart medicationOne of the world’s largest pharmaceutical companies, MSD, will pay up to $2 billion for the rights to the experimental drug HRS-5346 from China’s Jiangsu Hengrui Pharmaceuticals Co. for heart treatment. The deal is expected to be completed in the second quarter of 2025, pending the necessary approvals. This will be MSD’s second recent attempt…
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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…