Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients' Access to Medicines.

ABSTRACT:

Background

This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since the previous study, which evaluated the Turkish review processes and timelines 2013 to 2015.

Methods

Data related to the Turkish Medicines and Medical Devices Agency (TİTCK) organizational structure and general information were collected from publicly available sources. A standard questionnaire was then used to collect data with the aim of identifying the TİTCK's review practices and key milestones for the marketing authorization process. Subsequently, a comparison with the previous study was conducted to identify the key changes and developments that had taken place from 2015- 2018.

Results

The Tİ

SUBMITTER: Koyuncu O 

PROVIDER: S-EPMC7008400 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature