Comparison of clinical trials in Turkish and European Union regulations

Legal regulations of clinical drug trials in Turkey are quite new. The earliest regulation is the Regulation on Medical Deontology, dated 1960. This regulation allows clinical trials, and regulating classical physicians-patient and physician-physician relations. The other legal regulation on drug trials conducted on human beings comes into force 1987. Finally, the Directive on Drug Researches, which was published 1993. The name of the 1993 bylaw is `?Bylaw on Drug Research??. With this regulation, clinical trials that are related drug in Turkey that appropriate international standards and legal rights of researchers and volunteers are guarantied. Two years later, the ministry?s Directorate of Drug and Pharmacy published the first edition of Good Clinical Practice Guidelines.There are some differences in between Turkey bylaw and EU directions. Some of them are; clinical trial sites, application documents for ethical committee, ethical committee structure, adverse event notification, power and duty of sponsor, speed up to process of approval, investigator qualifications and responsibility, penalties.Due to differences between EU directives and Turkish rules, Turkish health authorities, General Directorate of Pharmacy and Pharmaceuticals, has made a new draft regulation concerning with EU directions. The new document is `?Bylaw on the Clinical Trials Conducted by Medicinal Products Used in Humans??, and it is in parallel to the 2001/20/EC and 2005/28/EC directives. The new bylaw is an important step to solve differences between EU countries and our country.