The European Medicines Agency and the new EU drug approval systems

In 1993, a significant advance in simplifying the procedures relating to drug marketing authorization applications in the EU was made. At that time, the legal basis of a new drug approval system

Table 4.11 The nine-volume series that comprises 'The Rules Governing Medicinal Products in the European Union'

Volume 1 - Pharmaceutical Legislation

Volume 2 - Notice to Applicants

Volume 3 - Guidelines

Volume 4 - Good Manufacturing Practices

Volume 5 - Pharmaceutical Legislation

Volume 6 - Notice to Applicants

Volume 7 - Guidelines

Volume 8 - Maximum Residue Limits

Volume 9 - Pharmacovigilance

Medicinal products for human use

Medicinal products for human use

Medicinal products for human use

Medicinal products for human and veterinary use

Veterinary medicinal products

Veterinary medicinal products

Veterinary medicinal products

Veterinary medicinal products

Medicinal products for human and veterinary use was formed by an EU regulation and three directives. Central to this was the establishment of a European agency for the evaluation of medicinal products, the European Medicines Agency (EMEA), which is based in London and began work in January 1995. Two new marketing authorization (drug registration) procedures for human or veterinary drugs are now in place within the EU:

• a centralized procedure in which applications for a marketing licence are forwarded directly to the EMEA;

• a decentralized procedure based upon mutual acceptance or recognition of national authority decisions; disputes arising from this system are arbitrated by the EMEA.

The EMEA is comprised of:

• A management board, consisting of representatives of each EU member state and representatives of the European Commission and European Parliament. This group functions mainly to coordinate EMEA activities and manage its budget.

• Pre-authorization evaluation of medicines for human use unit. This unit provides scientific advice relating to quality, safety and efficacy issues, as well as relating to orphan drugs.

• Post-authorization evaluation of medicines for human use. This regulatory affairs unit is responsible for issues such as post-marketing surveillance of drugs.

• Veterinary medicines and inspections. This unit is responsible for veterinary marketing authorization procedures and inspections.

Central to the functioning of the EMEA are three committees:

• The Committee for Medicinal Products for Human use (CHMP). This committee is composed of 35 technical experts drawn from the various EU member countries. It is primarily responsible for formulating the EMEA's opinion on any medicinal product being considered for marketing approval under the centralized procedure.

• The Committee for Medicinal Products for Veterinary use (CVMP), whose structure and role is similar to the CPMP, except that it is concerned with animal medicines.

• The Committee for Orphan Medicinal Products (COMP), composed of a representative from each EU member state and EMEA and patient representatives. The COMP assesses applications relating to experimental medicines being granted 'orphan' status. Orphan medicines are those intended to treat rare diseases, and orphan designation results in a reduction of the fees charged by the EMEA when assessing marketing authorization applications.

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body's report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA's annual budget is of the order of €120 million. The key objectives of the EMEA may be summarized as:

• protection of public and animal health by ensuring the quality, safety and efficacy of medicinal products for human and veterinary use;

• to strengthen the ideal of a single European market for human and veterinary pharmaceuticals;

• to support the European pharmaceutical industry as part of the EU industrial policy.

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