European Medicines Agency drug approval authority

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

Source The main source of the information in this table is either the Food and Drug Administration (FDA) Web site or European Medicines Agency (EMEA) Web site. For biopharmaceuticals approved before 1995 limited information is available so the author used the most recent label (package insert) to derive the reproductive, carcinogeneticity, and genetic toxicology studies completed for marketing approval. 

Approval by the regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), as having clinical advantages over current treatments and a suitable safety prohle. 

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... 

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