Clinical Trials in Turkey
Journal Title: Turkish Journal of Hematology - Year 2013, Vol 30, Issue 2
Abstract
Turkey is an emerging economy in almost all sectors, and especially in pharmaceuticals. Turkey has had clinical trial legislation for a long time. There are also clinical trial regulations and guidelines. Turkey has taken major steps towards harmonizing its legislation with the European Union in the fi eld of clinical research and currently Turkish regulations are totally in line with EC Directives (EC 2001/20 and EC 2005/28). The main objective of this article is to discuss the relevant parts of the minimum necessary information on current legislation related to clinical trials in Turkey, instead of detailing all current legislation related to the clinical trials in Turkey as of 2011. Details of legislation mentioned in the article can be found in the Offi cial Gazette and on corporate websites. In order to protect the rights, well-being, and health of the subjects in accordance with internationally valid scientifi c and ethical standards, clinical trials must be performed within these legal regulation frameworks and attention should be paid to the presentation of quality and reliable data.
Authors and Affiliations
Hilal İlbars
Keywords
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- EP ID EP127188
- DOI 10.4274/Tjh.2013.0045
- Views 89
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