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A review of how long Türkiye's medicines regulator took to approve new medicines from 2016 to 2018, which found the agency's own review time falling while the total time to approval rose.
The study evaluated the review process and timelines of the Turkish Medicines and Medical Devices Agency (TİTCK) from 2016 to 2018 and compared them with an earlier study of 2013 to 2015. Data on the agency's structure came from public sources, and a standard questionnaire collected its review practices and the milestones of the marketing authorisation process for new active substances.
The figures predate the 2021 licensing regulation and its 2022 reliance article, which set a 210-day licensing period and 90 days for applications that rely on other regulators' assessments; no later official average for new cancer medicines was found.
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