Clinical Trials Directive
The Clinical Trials Directive is a European Union directive aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
The Member States of the European Union were required to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004.
This Directive was repealed by Regulation 536/2014, dated 16 April 2014, which took effect on January 31st, 2022. The regulation reflected a view that "the legal form of a Regulation" was more appropriate than a directive requiring member state transposition.
The Articles of the Directive
The Articles of the Directive:- Scope.
- Definitions
- Protection of clinical trial subjects
- Clinical trials on minors
- Clinical trials on incapacitated adults not able to give informed legal consent
- Ethics Committee
- Single opinion
- Detailed guidance
- Commencement of a clinical trial
- Conduct of a clinical trial
- Exchange of information
- Suspension of the trial or infringements
- Manufacture and import of investigational medicinal products
- Labelling
- Verification of compliance of investigational medicinal products with good clinical and manufacturing practice
- Notification of adverse events
- Notification of serious adverse reactions
- Guidance concerning reports
- General provisions
- Adaptation to scientific and technical progress
- Committee procedure
- Application
- Entry into force
- Addressees