European Agency for the Evaluation of Medicinal

The EMEA s key aims, according to the EU Enterprise Directorate-General publication, are to  

For our purposes, the committee for drug approval is the CPMP. Applications are submitted to the EMEA according to the centralized procedure. The review process is described in Chapter 8. From 1995 to June 2002, the EMEA received 353 applications. The CPMP has provided 237 opinions (decisions) on 179 medical compounds, of which five were negative opinions. 

Another relevant Council Regulation is EEC/2309/93, and together with Directive 75/319/EEC, it requires Member States to establish national pharmacovigilance system to collect and evaluate information on adverse reactions to medicinal products and to take appropriate actions. 

Clinical trial applications are not centralized. Submissions are made through individual Member States. Refer to Chapter 8 for details of clinical trial application in Europe. 

The Japanese pharmaceutical market is the second largest in the world. It is larger than the combined markets of the United Kingdom, France and Germany. 

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CPMP Note for Guidance on the Investigation of Bioavailability and bioequivalence (CPMP/EWP/QWP/ 1401/98) The European Agency for the Evaluation of Medicinal Products, 2001. 

Includes information on the European Agency for the Evaluation of Medicinal Products. 

The European Agency for the Evaluation of Medicinal Prodncts, 2003. Note for guidance. AvaUahle http //enropa. en/agencies/community agencies/emea/index en.htm accessed 30 November 2009. 

The EU Directive 92/18/EEC [122] introduced for the first time the requirement for an ERA, as a prerequisite to obtain marketing authorization for veterinary pharmaceuticals. For this purpose, the European Agency for the Evaluation of Medicinal Products (EMEA) published a Note for Guidance where guidelines to assess the environmental risk of veterinary medicinal products are established [123]. 

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