1997/0197(COD)

Clinical Trials Good Clinical Practice Directive

Proposal for EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on the approximation of provisions laid down by law, regulation or administrative action relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use

Stage: In force, reached 1 May 2001
In force: In force since 1 May 2001 · CELEX 32001L0020
Transposition deadline: 1 May 2003
Procedure: Directive · Ordinary legislative procedure
Last activity: 1 May 2001

11 documents

Documents

Newest first. Each opens at its source.

OJ C 232 17.08.2001, p. 0010Commission · 17 Aug 2001
Text adopted · OJ L 121 01.05.2001, p. 0034Commission · 1 May 2001
Text adopted · Directive 2001/0020Commission · 4 Apr 2001
OJ C 300 20.10.2000, p. 0032Commission · 20 Oct 2000
OJ C 161 08.06.1999, p. 0005Commission · 8 Jun 1999
OJ C 379 07.12.1998, p. 0005Commission · 7 Dec 1998
OJ C 095 30.03.1998, p. 0001Commission · 30 Mar 1998
OJ C 306 08.10.1997, p. 0009Commission · 8 Oct 1997
Report · A4-0407/1998Parliament
Report · A5-0349/2000Parliament
Text adopted · T5-0548/2000Parliament

Summary

Generated

Directive 2001/20/EC harmonizes national rules on good clinical practice for clinical trials of medicinal products in humans. Member States had to apply it by 1 May 2004. It requires ethics committee opinions and competent authority authorization within 60 days, sets protections for minors and incapacitated adults, and mandates adverse reaction reporting.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 6 Oct 2026. Something wrong on this page? Report an error.

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