European Legislation
- Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
- Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of 16 April 2014 - Revokes Directive 2001/20/EC and concerns Clinical Trials of medicinal products for human use.
- Directive 2001/83/EC of 6 November - Establishes a Community code relating to medicinal products for human use.
- Commission Directive (EU) 2017/1572 of 15 September 2017 - Supplements Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use. (Text with EEA relevance.)
- Commission Decision (EU) 2021/1240 of 13 July 2021 - On the conformity of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No. 536/2014 of the European Parliament and of the Council. (Text with EEA relevance.)
- Directive 2004/27/EC of 31 March - Amends Directive 2001/83/EC establishing a Community code relating to medicinal products for human use.
- Directive 2005/28/EC of 8 April - Lays down detailed principles and guidelines of good clinical practice in respect of investigational medicinal products for human use, as well as the requirements applicable to authorisations for the manufacturing or importation of such products.
- Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
ICH Guidelines
Some of the most important ICH guidelines are listed below, available for consultation at https://www.ich.org/page/efficacy-guidelines:
E3 - Note for Guidance on Structure and Content of Clinical Study Reports
E6 - Good Clinical Practice
E8 - General Considerations for Clinical Trials
E11 - Clinical Investigation of Medicinal Products in the Paediatric Population
All ICH guidelines and scientific guidelines relevant to the conduct of clinical trials can be consulted on the European Commission and European Medicines Agency (EMA) websites.
European Commission (EC) Guidelines
Chapter I: Submission and Application Form
Chapter II: Monitoring and Pharmacovigilance
Chapter III: Quality of the Investigational Medicinal Product
Chapter IV: Inspections
Chapter V: Additional Information
Chapter VI: Legislation
European Commission - Clinical Trials
