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).
The TİTCK updated the application procedures for clinical trial meetings held online during the pandemic:
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.
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.