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The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
Portugal: 0.874 26,270 ... Classification of countries according to the World Bank: ... Organization for Security and Co-operation in Europe.
In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide ...
The European Union Drugs Agency (EUDA), known until 2024 as the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), is an agency of the European Union headquartered in Lisbon, Portugal, and established in 1993. In June 2022, [4] the Council of the European Union approved a reform of the organization which lead to an extension of ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The European Medical Association (EMA) was established by doctors from the 12 member states in 1990 in Belgium, [1] EMA is the main association representing Medical Doctors in Europe, supporting the European Commission - Lifelong Learning Programme (LLP).
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.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.