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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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Amended Drug Registration Rules Come into Force in the EAEU
Read more: Amended Drug Registration Rules Come into Force in the EAEUAs of June 21, the updated Rules for the Registration and Examination of Medicinal Products for Human Use in the Eurasian Economic Union (EAEU), approved by the Council of the Eurasian Economic Commission (EEC), have come into effect, the EEC press service reported. “The new provisions are aimed at harmonizing the registration processes across EAEU…
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U.S. Plans to Impose Tariffs on Pharmaceuticals by End of July
Read more: U.S. Plans to Impose Tariffs on Pharmaceuticals by End of JulyWashington will start with a low tariff rate and give companies “a year or so” to move production to the U.S., after which the tariff will become “very high,” said U.S. President Donald Trump. The United States will impose customs tariffs on pharmaceutical products, likely by the end of this month. This announcement was made…
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EU Tariffs May Trigger Rising Drug Prices in the U.S.
Read more: EU Tariffs May Trigger Rising Drug Prices in the U.S.The chief economist at consulting firm RSM US noted that tariffs and the ongoing revision of trade terms with other countries will become “a defining feature of U.S. trade policy in the foreseeable future.” Tariffs on European goods, outlined in a trade agreement between Washington and Brussels, could lead to higher prices for imported medical…
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Lawyer Reports Ban on Operations of Miramistin Antiseptic ManufacturerCourt Restricts Operations of Miramistin Antiseptic Manufacturer in Russia
Read more: Lawyer Reports Ban on Operations of Miramistin Antiseptic ManufacturerCourt Restricts Operations of Miramistin Antiseptic Manufacturer in RussiaThe operations of the company that produces the antiseptics Miramistin and Okomistin have been completely blocked in Russia following a court ruling, according to a lawyer. The measures affected the work of 164 medical representatives of Infamed LLC. The manufacturer of the antiseptics Miramistin and Okomistin has been blocked from operating throughout Russia due to…
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PharmEco to Launch Oncology Drug Production with ₽9.1 Billion Investment
Read more: PharmEco to Launch Oncology Drug Production with ₽9.1 Billion InvestmentThe PharmEco Group of Companies will build a pharmaceutical manufacturing facility for oncology treatments in Chernogolovka, Moscow Region, by 2030. The total investment in the project is estimated at 9.1 billion rubles. A trilateral agreement was signed during the St. Petersburg International Economic Forum (SPIEF 2025) between the Ministry of Investment, Industry and Science of…
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Russian Government Introduces New Procedure for Releasing Medicines into Civil Circulation
Read more: Russian Government Introduces New Procedure for Releasing Medicines into Civil CirculationThe Russian government has approved updated regulations governing the release of medicines into civil circulation. The new rules cover: Various versions of the draft regulation were published by the Ministry of Health in January and February 2025. The newly adopted procedure replaces the 2019 regulation, which was originally set to expire in September 2025. The…
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National Preference Benefits Will Now Apply to All Russian-Made Medicines, Not Just Those on the Vital Drugs List
Read more: National Preference Benefits Will Now Apply to All Russian-Made Medicines, Not Just Those on the Vital Drugs ListThe Russian government has amended its decree on measures for granting national treatment in the procurement of goods, works, and services for state and municipal needs. The original document, adopted in late December 2024, extended the “third-party exclusion” mechanism (“the second extra one”) to the purchase of medicines from the list of vital and essential…
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Medicine Sales in Russia Surpass 1 Trillion Rubles Since Beginning of the Year
Read more: Medicine Sales in Russia Surpass 1 Trillion Rubles Since Beginning of the YearFrom January to April 2025, medicine sales in Russia reached 1.03 trillion rubles. Compared to the same period in 2024, this represents a 17% increase. In physical volume, however, the market grew by only 2%, with 1.92 billion packages sold. According to a report by the analytics company AlphaRM, the pharmaceutical market exceeded 1 trillion…
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Pfizer CEO Proposes a “Pharmaceutical NATO” with Fixed Spending on Medicines
Read more: Pfizer CEO Proposes a “Pharmaceutical NATO” with Fixed Spending on MedicinesPfizer CEO Albert Bourla has called on European countries to increase their spending on medicines. He proposed setting a fixed percentage of GDP per capita for such expenditures, similar to NATO’s defense spending commitments. Speaking at the annual Goldman Sachs healthcare conference, Bourla urged developed countries to boost funding for innovative drugs. The text of…