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EU Directives

Listed below are many links relating to the EU GCP Diretive; EU Clinical Trial Directive; EU Clinical Trial Directive Implementing Texts; and country-specific links to the National Regulatory Authorities of EU Member States and other European Countries.

Europa - The European Union Online
Europa is the portal site of the European Union. It provides up-to-date coverage of European Union affairs and essential information on European integration.

EU Clinical Trials Directive
The current version of directive 2001/20/EC as published in Official Journal L121 on 01 May 2001 (PDF format).

EU Clinical Trial Directive - Implementing Texts
Implementing texts for Directive 2001/20/EC.

EU GCP Directive
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)

National Regulatory Authorities
Country-specific links to the National Regulatory Authorities of EU Member States and other European Countries.
EU Member States:

Austria
Ministry for Health and Women
(German)

Belgium
Directorate General for Medicinal Products
(English)

Cyprus
Ministry of Health
(English)

Czech Republic
State Institute for Drug Control
(English)

Denmark
Danish Medicines Agency
(English)

Estonia
State Agency of Medicines
(English)

Finland
National Agency for Medicines
(English)

France
L'Agence Francaise de Securite Sanitaire des Produits de Sante (French)

Germany
Federal Institute for Drugs and Medical Devices (BfArM)
(English)

Greece
National Drug Organization
(Greek)

Hungary
National Institute of Pharmacy
(English)

Ireland
Irish Medicines Board
(English)

Italy
Ministry of Health
(Italian)

Latvia
State Agency of Medicines
(English)

Lithuania
State Medicines Control Agency
(English)

Luxembourg
Ministry of Health
(French)

Netherlands
Dutch Medicines Evaluation Board
(English)
Central Committee on Research Involving Human Subjects (CCMO)

Portugal
Instituto da Farmacia e do Medicamento (INFARMED)
(Portugese)
Portugese Clinical Trial Regulations (Portugese)

Spain
Ministerio de Sanidad y Consumo
(Spanish)

Sweden
Medical Products Agency
(English)

UK
Medicines & Healthcare products Regulatory Agency (MHRA) (English)

Other European Countries:

Bulgaria
Bulgarian Drug Agency
(English)

Iceland
Ministry of Health and Security
(English)

Norway
Norwegian Medicines Agency
(English)

Romania
State Institute of Drug Control
(Romanian)

Russia
Ministry of Health
(Russian)

Switzerland
Federal Office of Public Health (SFOPH)
(English)

Turkey
Ministry of Health
(Turkish)

“I appreciate both of you again for your excellent audit and teaching me a lot about CRO audit, GCP and related regulations etc.”
O.O., Director Regulatory Auditing, Japanese Pharma