NLClinicalTrialsIMP object

Applicable national regulations

National Act on Medicinal Products

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Regulation on Clinical Trials of Medicinal and Biological Products (previously titled Regulation on Clinical Trials), No. 29041 of the Official Gazette, June 25, 2014

Additional Information

ad Regulation on Clinical Trials of Medicinal and Biological Products 2014: This Regulation is issued based on Supplemental Article 10 of Fundamental Law #3359 dated 07.05.1987 on Health Services and Articles 27 and 40 of Decree Law #663 on the Organization and Mandate of the Ministry of Health and Its Subordinate Agencies, and is aligned with Directives 2001/20/EC and 2005/28/EC concerning Good Clinical Practice, constituting a part of European Union’s legislations governing medicinal products. Retrospective studies are not covered by this regulation.

Please refer to the 'Guideline for Good Clinical Practice (2014)' for general principles regarding clinical trials. Guidelines on other relevant topics are also provided by the Ministry.

An overview on the current legislation related to the conduct of clinical trials in Turkey has been recently published and is publicly available:
Ilbars H. Clinical Trials in Turkey. Turk J Haematol 2013;30:111–114.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395