European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London.
'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.'

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.

	Years	Test Population	Purpose	Success Rate
Preclinical Testing	3.5	Laboratory and animal studies	Assess safety and biological activity	5,000 compounds evaluated
File IND at FDA
Phase I	1	20 to 80 healthy volunteers	Determine safety and dosage	5 enter trials
Phase II	2	100 to 300 patient volunteers	Evaluate effectiveness, look for side effects
Phase III	3	1000 to 3000 patient volunteers	Verify effectiveness, monitor adverse reactions from long-term use
File NDA at FDA
FDA	2.5	Review process / Approval		1 approved
	12 Total
Phase IV	Additional Post marketing testing required by FDA

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, Clinical Trial, Food and Drug Administration, and European Medicines Agency.