Recent Development
On July 25, 2020, the Turkish Medicine and Medical Devices Authority (“TİTCK”) updated its Frequently Asked Questions (FAQ) document and COVID-19 measures document regarding clinical trials. The TİTCK’s relevant announcements and updated documents are available online here (in Turkish).
What’s New?
The TİTCK updated the application procedures for clinical trial meetings held online during the pandemic:
- The 30-day period for meeting applications filed with the TİTCK will now be five business days. In other words, applicants must file their meeting applications to the TİTCK within five business days before the meeting date.
- The applicants will be able to file meeting applications with the TİTCK for clinical trials that are not officially approved by the Ethics Committee or the TİTCK. However, for these applications, the applicants must submit a copy of the cover letter relating to the initial application to the Ethics Committee.
In addition, the TİTCK noted that it will apply expedited assessment procedures for clinical trial applications relating to COVID-19.
As per the updates to the FAQ documents, the TİTCK provided additional explanations for on-premise monitoring activities, applications through the clinical trial module and COVID-19 PCR tests performed during the clinical trials.
Conclusion
The TİTCK continues to take active steps to protect the public against the COVID-19 pandemic in Turkey. All sponsor companies must implement the TİTCK’s measures, integrate them to their processes and conduct risk assessments.
Please refer to The Esin Attorney Partnership Coronavirus Helpdesk for our client alerts regarding the legal consequences of COVID-19 on other areas.
