Clinical Trials in Turkey
نویسنده
چکیده
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. Turkey offers good opportunities with regard to the high number of enthusiastic physicians and, moreover, the higher availability of treatment-naive patients interested in participating in clinical trials. Turkey is in the review phase to join the European Union and has undergone many important reforms involving patients rights, criminal law, specialized biotech drug dispensing acts, and so on. Along with policies and visions for scientifi c and technological development put forward by the EU in the mid-1990s, Turkey has taken major steps towards harmonizing with the EU in the fi eld of clinical research and drug trials. Turkey is known for its unique geographical location, straddling the continents of Europe and Asia with borders to 7 countries: Greece and Bulgaria to the northwest, Syria to the south, Iraq to the southeast, and Armenia, Georgia, and Iran to the east. It is a bridge to Europe from Asia and the Middle East. 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 EU 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). Thus, there are ethics committees. According to the Turkish clinical trial …
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