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euda.europa.eu. 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 ...
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 Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. [1][2] EFSA was established in February 2002, is based in Parma, Italy, and for 2021 it has a budget of €118.6 million, and a total staff ...
v. t. e. The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). [4][5] The EMA was set up in 1995, with funding ...
The Innovative Medicines Initiative (IMI) is a European initiative to improve the competitive situation of the European Union in the field of pharmaceutical research.The IMI is a joint initiative (public-private partnership) of the DG Research of the European Commission, representing the European Communities, and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
The European Union has no major administrative responsibility in the field of healthcare. The European Commission's Directorate-General for Health and Consumers however seeks to align national laws on the safety of food and other products, on consumers' rights, and on the protection of people's health, to form new EU wide laws and thus strengthen its internal markets.
The slow pace of approval was criticized as endangering European food safety [18] [19] although as of 2012, the EU had authorized the use of 48 genetically modified organisms. Most of these were for use in animal feed (it was reported in 2012 that the EU imports about 30 million tons a year of GM crops for animal consumption.