European Medicines Agency (EMA) is a decentralized body of the European Union with headquarters in Amsterdam.
'The EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. The EMEA has a role in both, but is primarily involved in the centralized procedure. Where the centralized procedure is used, companies submit one single marketing authorization application to the EMEA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorization valid for the whole of the European Union.'
'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. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization.'

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials, and Drug Development and Approval Process USA.

Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.


By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'

See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.

Different stages of testing drugs in humans for example ultrasound contrast agents, from first application in humans through limited and broad clinical tests, to postmarketing studies. Preclinical trials are the testing in animals.

See also Drug Development and Approval Process USA, Food and Drug Administration, and European Medicines Agency.