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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 Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency 's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market. MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the ...
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.
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.
BRUSSELS (Reuters) -The European Commission published its first list of critical medicines, as part of a wider overhaul of laws governing the 136 billion euro ($148 billion) pharmaceuticals ...
European Medicines Agency data breach. In December 2020 the European Medicines Agency announced that it had been targeted in a cyberattack. [1][2] The agency announced that it had opened a full investigation in close cooperation with law enforcement and other entities but declined to give details of the attack while the investigation was ...
www.edqm.eu. 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]).