Following formal assessment by WHO, Türkiye has achieved maturity level 3 (ML 3) in WHO’s classification of regulatory authorities for medicines and vaccines. Achieving ML 3 brings Türkiye closer to becoming a WHO listed authority, a scheme operational since March 2022 which lists the world’s regulators of reference.
The WHO assessment of regulatory authorities is based on the ‘ Global Benchmarking Tool‘ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators beginning with ML1 describing the existence of some elements of a regulatory system. Maturity Level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, Maturity Level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement.
The benchmarking of the National Regulatory System of Türkiye, represented by the Turkish Medicines and Medical Devices Agency (TİTCK) and other relevant regulatory institutions of Türkiye was initially conducted in 2022 through to September 2023, in close collaboration with the WHO Regional Office for Europe (EURO).
WHO’S global benchmarking is part of the WHO programme for regulatory system strengthening and covers core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 are considered eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.
Dr Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products said ‘this represents a significant milestone for Türkiye, as TİTCK has reached the level of a regulatory system operating as a stable, well-functioning regulatory system for medicine and vaccine regulation with integrated functions. This achievement is the result of investment by the Government of Türkiye in the strengthening of their regulatory systems’.
Regulation of medical products is extremely important for all health systems and for access to quality vaccines, medicines and other health products. Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as timely authorization of medical products and safety monitoring.
