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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]
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 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 Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
The European Union (EU) medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and European Medicines Agency (EMA). EMA and the Member States cooperate and share expertise in the assessment of new ...
In 2016, the Swedish National Audit Office published an audit report examining how the state (the government, the Medical Products Agency, the National Board of Health and Welfare and the Swedish Agency for Medical and Social Evaluation) handles the pharmaceutical industry's influence over state drug control and knowledge management. [1]
For more companies, head on over to 5 Biggest European Pharmaceutical Companies. Alongside the United States, Europe has some of the most advanced industries and economies in the world.
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.