European Medicines Agency EMEA centralized procedure

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

Council Regulation 726/2004/EC (updates and expands the previous regulation 239/1993/EC), which mainly concerns the duties of the European Medicines Agency (EMEA), establishment of the Committee for Medicinal Products for Human Use (CHMP), and the scope and mechanisms of the centralized procedure for marketing authorization applications (MAAs) and pharmacovigilance issues. 

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. 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. 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. 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. 

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). 

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). 

Since 1993, there is an administrative authority responsible for medicines in the entire European Union, enacted by Council Regulation (EEC) No. 2309/93. This European Agency for the Evaluation of Medicinal Products (EMEA) is responsible for coordinating the scientific resources put at its disposal by the competent authorities of the member states for the evaluation and supervision of medicinal products for human use. A marketing authorization granted under the centralized procedure by EMEA is valid for all member states. 

Directive 2309/93 introduced further changes. It established a new body that is based in London, The European Medicines Evaluation Agency (EMEA), established January 1 1994, and two procedures for the obtaining entry to the markets of the member states, namely the multistate or decentralized or mutual recognition procedure and the centralized procedure see Figures 28.1 and Figure 28.2, which show schematically the procedures which became operative on January 1 1995. 

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