European Medicines Agency mutual recognition 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 (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). 

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. 

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. 

---