European Medicine Evaluation Agency establishment

Membership of the European Union and the establishment of the European Medicine Evaluation Agency (EMEA) have added a European dimension to monitoring of adverse drug reactions in the UK and given it a new title of pharmacovigilance . The requirements arising from the European dimension are summarised later. 

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 features of a particular biopharmaceutical are the result of the basic characteristics of the molecule such as amino acid sequence and three-dimensional structure as well as the specihc production, purihcation, formulation, and storage conditions (Box 12.4-2). To produce a biopharmaceutical of constant required quality, a company also needs the experience and the in-house standards to apply the methods used to analyze the structure of a given product. There are various guidelines of the European Medicine Evaluation Agency, the Food and Drug Administration, the Japanese Ministry of Health and Welfare, and the ICH, which require manufacturers to show that they control the production process and are capable of reproducibly manufacturing batches that not only meet product specih-cations, but also conform to the dehnition of the product as established through full characterization. Modihcations of the established process are only accepted if the manufacturer can show that the product of the new process is comparable with the initially manufactured product. Comparability studies include revalidation of... 

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. 

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]. 

European Agency for the Evaluation of Medicinal Products (EMEA) The agency established by a commission composed of fifteen member countries of the European Union (EU). The commission is working through harmonization of technical requirements and procedures to achieve a single market for pharmaceuticals that would allow free movement of medicinal products throughout the EU. 

The European Union (EU) ageneies responsible for the scientific evaluation of the safety of feed additives and veterinary medicinal products are, respectively, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). The EFSA is advised on scientific aspects of feed additives, including the safety of target species, consumers, users and the environment, by the Panel on Additives and Products or Substances Used in Animal Feed (FEEDAP). Some of the older evaluations of feed additive uses of coccidiostats under Directive 70/524/EEC were performed by the Scientific Committee on Animal Nutrition (SCAN), which reported to the European Commission prior to the establishment of EFSA. The Committee for Medicinal Products for Veterinary Use (CVMP) advises the EMA on scientific aspects of veterinary medicines. The distinction between medicinal and feed additive uses is not always clear, as some uses to prevent coccidiosis are considered to be medicinal e.g. use of lasalocid in poultry). 

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. 

A central EEC registration authority (European Agency for the Evaluation of Medicinal Products) will be established and "shall take up its responsibilities on 1 January 1995 (Council Directive 2309/93 of 22 July 1993). The Committee on Proprietary Medicinal Products, CPMP, which consists of members of the Commission and from the states authorities, plays a central role in the existing and future system. It is assisted by different working parties for specific areas. The CPMP coordinates the procedures, assesses applications and provides "opinion reports" and acts as arbitrator in the case of national discrepancies. However, the opinion reports and decisions of the CPMP are not (yet) binding to the member states. For veterinary products identical rules apply here a CVMP acts as the central body. 

In addition to the ICH, the Committee for Proprietary Medicinal Products, under the European Agency for the Evaluation of Medicinal Products (EMEA), issued, in 1997 and 1998, a number of stability-related guidances to be used for establishing stability testing protocols for drug products to be filed in European countries. The documents complement and supplement the ICH guidelines and are listed below ... 

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