Recent Development
On February 25, 2020, the Turkish Medicine and Medical Devices
Authority ("TİTCK") announced the
instructions for clinical trial registrations and annual
notifications through the Clinical Trials Module.
The TİTCK also published the Guidelines for the Import of
Investigational Products to Be Used in Clinical Trials
("Guidelines") on February 27, 2020. The
Guidelines entered into force on February 26, 2020.
What's New?
Clinical Trial Registrations and Annual Notifications
According to the Guidelines for Clinical Trial Applications, the applicants (sponsors or contract research organizations) must register ongoing clinical trials with the Clinical Trials Module ("Module") within the period announced by the TİTCK. Accordingly, the TİTCK announced that the clinical trials approval applications made to the TİTCK in 2016 and 2017 must be registered with the Module between February 28 to March 27, 2020. Annual notifications of clinical trials registered with the Module will be made within the same period through the Module. Annual notifications of clinical trials approval applications made in 2015 or earlier will be made through the Electronic Application System between March 30 to April 20, 2020.
The TITCK also noted that the completed clinical trials, ongoing bioavailability/bioequivalence studies, and observational studies would not be registered with the Module.
Guidelines for the Import of Investigational Products Used in Clinical Trials
Pursuant to the Regulation on Clinical Trials, the manufacturing and import of investigational products to be used in clinical trials are subject to the TİTCK's approval. Accordingly, the Guidelines set out the principles and procedures for the import applications of investigational products.
The Guidelines provide that sponsors or their legal representatives must file the import applications in accordance with the applicable legislation. Applicants must fill out the cover letter and application form available on the TİTCK's website and provide information on the amount of investigational product required for the clinical trial. The TİTCK evaluates the applications within 15 days.
The Guidelines are available here (in Turkish).
Conclusion
The TİTCK continues to provide guidance for companies involved in clinical trials. Accordingly, companies should carefully review the Guidelines for import applications, follow the TİTCK's announcements and make their clinical trial registrations and annual notifications by following the TİTCK's instructions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.