Participation in IPhEB Russia 2021April 19, 2021
European and US regulators agree on mutual recognition of inspections of medicines manufacturers
Transatlantic agreement will help to make better use of inspection capacity and reduce duplication
Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
Each year, national competent authorities from the EU and the US Food and Drug AdministrationExternal link icon (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s inspections in their own territories. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union.
Read full article HERE
Participation in INNOPROM 2021 in UzbekistanApril 12, 2021
Inpharmatis обсудил Цифровизацию системы здравоохранения УзбекистанаApril 09, 2021
Inpharmatis на выставке «Иннопром» 2021 в УзбекистанеApril 08, 2021
2021 EAEU regulatory changesJanuary 15, 2021
Webinar: EAEU Regulatory Challenges and OpportunitiesNovember 09, 2020
Readability user testing is requested in EAEUOctober 15, 2020
Inpharmatis & Epista Partnership AnnouncementSeptember 03, 2020
User Testing Instructions Webinar on 30 April in RussianApril 27, 2020
Inpharmatis Team COVID-19 UpdateMarch 30, 2020