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European Medicines Evaluation Agency regulations

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... [Pg.237]

Committee on Proprietary Medicinal Products (CPMP) A committee, composed of two people from each EU Member State (see European Union (EU) ), that is responsible for the scientific evaluation and assessment of marketing applications for medicinal products in the EU. The CPMP is the major body involved in the harmonization of pharmaceutical regulations within the EU and receives administrative support from the European Medicines Evaluation Agency. See European Medicines Evaluation Agency (EMEA). ... [Pg.15]

Benzi, European Medicines Evaluation Agency Abraham, "Science and Politics of Medicines Regulation. ... [Pg.176]

Council Regulation (EEC) No. 2309/93 (see below) stands at the origin of the European Medicines (Evaluation) Agency (EMEA). Established in 1995, EMEA s main task is to coordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either a Centralized (CP) or Mutual Recognition Procedure (MRP) for authorization. All scientific questions arising in these procedures are dealt with by the EMEA. (A detailed description of how these procedures work is given below). [Pg.1677]

Some legal standards and regulations have already been issued by appropriate institutions for three important areas, that is, Europe [European Medicines Evaluation Agency (EMEA)], United States [Center for Drug Evaluation and Research (CDER)], and Japan [Pharmaceutical and Medicinal Safety Bureau (PMSB)]. [Pg.256]

Council Regulation (EC) No 297/95, of February 10, 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products. Amended by Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products. Council regulation 2743/98 (fees for scientific advice). [Pg.484]

Centralized procedure Under the European Union (EU) Council Regulation (EEC No. 2309/93), a Centralized Community Procedure for the authorization of medicinal products was created. The European Agency for the Evaluation of Medicinal Products (EMEA) was formed in 1995 to coordinate scientific evaluation of the safety, efficacy and quality of medicinal products under this procedure. All biologies are under the purview of EMEA evaluation, and it is optional for other conventional drug products (synthetic drugs). [Pg.166]

Regulation (EEC) No 2309/93. Council Regulation (EEC) No 2309/9 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. [Pg.444]


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See also in sourсe #XX -- [ Pg.260 ]




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