by Mike Bennoson 

The regulatory structure in Europe is diverse and operates on different levels including policy, enactment, and enforcement.

The Council of Ministers

The Council of Ministers is the only institution that directly represents the Member Governments, and each has a seat on the Council.

The EUROPEAN Commission

The Commission is the administrative branch of the European Union ( EU ) based in Brussels which can propose legislation and implement it while the Council is responsible for its adoption.

Both the Council and Commission can issue:

• Regulations - which automatically become Community Law
• Directives - which are binding on Member States as to the ends, but not the means (i.e. have to be incorporated into National laws)
• Decisions - which are binding on those to whom they are addressed (Member States, enterprises, and individuals)
• Recommendations and Opinions - which are not binding

Several Directorates General (DG) within the Commission are responsible for The Internal Market and Industrial Affairs. Of particular relevance in Enterprise DG is Unit F2, Pharmaceuticals - Regulatory Frameworks and Market Authorisations.

*EUROPEAN MEDICINES AGENCY (EMEA)

The European Medicines Agency (EMEA) was established in 1993; London was chosen as its seat and located there in January 1995. It is a decentralized body of the EU.

The Agency's main responsibility is the promotion and protection of public and animal health and it coordinates the existing scientific resources put at its disposal by the Member States of the European Union (EU) for the evaluation, supervision and pharmacovigilance of medicinal products for both human and veterinary use throughout the entire EU. The EMEA is primarily involved in the centralized procedure but plays a role in mutual recognition.

On the basis of the opinions of the Agency's scientific committees, the European Commission authorizes the marketing of biotechnology and innovative products. In addition, it arbitrates between member states for medicinal products being assessed under the mutual recognition procedure.

The Agency comprises of:

1. a management board which consists of one representative per Member State, two representatives of the European Commission, two representatives of the European Parliament. In addition two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations are appointed by the Council of Ministers in consultation with the European Parliament The Board approves the Agency's budget and work programme.
2. four scientific committees, responsible for preparing the Agency's opinions relating to the evaluation of human medicines (CHMP), veterinary medicines (CVMP), herbal medicinal products (CMPH) and the designation of 'orphan' medicines for rare diseases (COMP).
3. EMEA staff of over 300 headed by the Executive Director
4. A network of over 3000 European experts which underpins the scientific work of EMEA and its committees.

MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS

Marketing authorisations granted in one Member State can be recognised by other Member States who may grant similar marketing authorisations for their own territories. A centralised procedure can be followed submitted to EMEA to obtain a single authorisation valid throughout the Community. This procedure is mandatory for certain types of product and optional for certain others. In all cases the dossier requirements submitted to demonstrate the safety, quality and efficacy are the same.

GOOD MANUFACTURING PRACTICE

In the field of GMP, The European Commission is responsible for legislation and guidelines as encompassed in Volume 4 of the rules governing medicinal products in the European Union. The Commission uses the experts of the Member States in developing proposals and this is co-ordinated through the EMEA.

EMEA maintains the Compilation of Community Procedures on Inspections and Exchange of Information which includes quality system requirements for Inspectorates and is a key harmonising tool facilitating confidence in the reliance of Member States on each others inspections.

EMEA also co-ordinates activities required to establish and maintain Mutual Recognition Agreements on behalf of the Commission.

Inspections required in connection with centralised products are carried out by the Supervisory Authority (the Competent authority of the Member State in which the relevant manufacturer or importer is located) and co-ordinated by EMEA.

EMEA maintains links with many international bodies including PIC/S.

EUROPEAN NATIONAL REGULATORY AUTHORITIES

Each Member State has its own National Competent Authorities responsible for safeguarding public health by ensuring medicines meet appropriate standards of quality, safety and efficacy. The national authorities provide the experts used by the EMEA in fulfilling its role.

* Previously known as the European Agency for the Evaluation of Medicinal Products or the European Medicines Evaluation Agency but the new name retains the acronym EMEA. The EMEA web address is www.emea.eu.int

About the Author
Michael J. Bennoson joined ISPE in May 1996 and supports the European office in the development of European educational programs and ISPE links with regulatory authorities. Bennoson obtained a Bachelor of Technology degree in industrial chemistry from the University of Bradford, England. He emigrated to Montreal, Canada where he spent four years in quality assurance at Ayerst Laboratories. He then emigrated to New Zealand and established GMP inspections for the government as head of inspection for the Department of Health. Upon his return to the UK, he joined Wellcome (now GSK) in quality assurance, retiring as director of quality assurance operations, UK in December 1995. Bennoson was chairperson of the UK industry GMP Committee for 13 years and participated in a number of European working groups.