

Melis Sılacı Korkmaz
Aug 3, 2023
The Guideline on Observational Studies of Medical Products for Human Use (the “Guideline”) was published by the Turkish Medicines and Medical Devices Agency on 03.08.2023.
The Guideline on Observational Studies of Medical Products for Human Use (the “Guideline”) was published by the Turkish Medicines and Medical Devices Agency on 03.08.2023.
The Guideline has been prepared to offer guidance to applicants and clinical trial ethics committees on the scope, planning, conduct and evaluation of observational studies of medicinal products for human use.
Retrospective studies are excluded from the scope of the Guideline. Other trials conducted with medical products for human use but not conducted in accordance with the principles set out in the Guideline are also considered outside its scope evaluated within the scope of the Regulation on Clinical Trials of Medical Products for Human Use published in the Official Gazette dated 27/5/2023 and numbered 32203.
With the entry into force of the Guideline, the Guideline on Observational Drug Studies dated 13.11.2015 has been abrogated.
You may review the Guideline in Turkish from here.