European medicines agency
European Medicines Agency (EMA)
European Medicines Agency (EMA) (pronunciation: /ˈjʊərəpiːən ˈmɛdɪsɪnz ˈeɪdʒənsi/), is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Etymology
The term "European Medicines Agency" is self-explanatory, with "European" referring to its jurisdiction within the European Union, "Medicines" indicating its focus on pharmaceuticals, and "Agency" signifying its role as a regulatory body.
History
The EMA was established in 1995 with the aim to harmonise the evaluation and supervision of medicinal products across the member states of the EU. It replaced the Committee for Proprietary Medicinal Products and the Committee for Veterinary Medicinal Products, which had previously been responsible for the evaluation of medicinal products in the EU.
Role and Responsibilities
The EMA's main responsibility is to provide independent, science-based recommendations on the quality, safety and efficacy of medicines, and to monitor their safety throughout their life cycle. The EMA also provides scientific advice to pharmaceutical companies on the development of new medicines.
Related Terms
- Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
- Clinical trial: A research study that tests how well new medical approaches work in people.
- Pharmaceutical company: A commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare.
- Regulatory affairs: The activities within the pharmaceutical industry that ensure compliance with regulations and laws pertaining to the development, production and sale of drugs and medical devices.
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