Snapshot

The TITCK Priority Assessments pathway has been developed by the Türkiye İlaç ve Tıbbi Cihaz Kurumu of Turkey.

This pathway accelerates the regulatory review process.

According to TITCK regulations, the overall approval target timeline is 210 calendar days, 180 calendar days for a prioritized accelerated review and 150 calendar days for highly prioritized products. However, prioritized accelerated review and highly prioritized are not defined in the regulation. Nevertheless, the draft updated registration regulation provides more clarity on those definitions. In any case, the actual approval timelines are much longer in practice than those stated in the TITCK regulation. The TITCK review process consists of the following common steps: validation of the submitted dossier, scientific assessment, company response and final authorization.