{"entity":{"id":"paper-koyuncu-titck-review-front-pharmacol-2020","kind":"paper","name":"Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients' Access to Medicines","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-11-04","links":[{"label":"Front Pharmacol 2020","url":"https://doi.org/10.3389/fphar.2019.01557"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/32116658/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["titck"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Frontiers in Pharmacology","year":2020,"doi":"10.3389/fphar.2019.01557","pmid":"32116658","authors":"Koyuncu O, Gursoz H, Alkan A, Cetintas HC, Pasaoglu T, Mashaki Ceyhan E, Walker S","paperType":"observational","findings":["The median approval time for new active substances rose from 529 calendar days in 2016 to 663 in 2018.","Over the same period the time spent in the agency's review fell from 408 to 326 calendar days, while company time rose from 137 to 268 days.","The authors recommend good review practices, a structured benefit-risk framework, verification and abridged reviews based on a reliance model, PIC/S mutual recognition and full ICH membership."],"whatItMeans":"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.","caveats":["Covers all new active substances, not cancer medicines separately.","The milestones were collected from the agency by questionnaire, not from an independent audit.","Measures time to a Turkish licence, not time to reimbursement by the Social Security Institution."]},"route":"/key-papers/paper-koyuncu-titck-review-front-pharmacol-2020/","neighbours":{"institution":[{"id":"titck","kind":"institution","name":"Turkish Medicines and Medical Devices Agency (TİTCK)","route":"/institutions/titck/"}]}}