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As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
The Heads of Medicines Agencies (HMA) is a network of both the human and veterinary medicines agencies of the European Economic Area. [1]The HMA co-operates with the European Medicines Agency and the European Commission (Directorate-General for Health and Food Safety) in the operation of the European medicines regulatory system.
State Agency of Medicines Zāļu valsts aģentūra (ZVA) 2004 Liechtenstein: Office of Healthcare Amt für Gesundheit (AG) 1995 Lithuania: State Medicines Control Agency (SMCA) 2009 Malaysia: National Pharmaceutical Regulatory Agency (NPRA) Bahagian Regulatori Farmasi Negara: 2002 Malta: Malta Medicines Authority (MMA) 2008 Mexico
The Innovative Medicines Initiative (IMI) is a public-private partnership designed by the European Commission and EFPIA. It is a pan-European collaboration that brings together large biopharmaceutical companies, small- and medium-sized enterprises (SMEs), patient organisations, academia, hospitals and public authorities.
Portugal, [e] officially the Portuguese Republic, [f] is a country in the Iberian Peninsula in Southwestern Europe.Featuring the westernmost point in continental Europe, Portugal borders Spain to its north and east, with which it shares the longest uninterrupted border in the European Union; to the south and the west is the North Atlantic Ocean; and to the west and southwest lie the ...
The Faroe Islands are not part of the Schengen Area, and Schengen visas are not valid. However, the islands are part of the Nordic Passport Union and the Schengen Agreement provides that travellers passing between the islands and the Schengen Area are not to be treated as passing the external frontier of the Area. [80]
The admission of a new state the Union is limited to liberal democracies and Freedom House ranks all EU states as being totally free electoral democracies. [54] All but 4 are ranked at the top 1.0 rating. [55] However, the exact political system of a state is not limited, with each state having its own system based on its historical evolution.
Emer Cooke is an Irish pharmacist and Executive Director of the European Medicines Agency (EMA) since November 2020. [1] She is also the chairperson at the International Coalition of Medicines Regulatory Authorities (ICMRA).