The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Hakki Gürsöz,Emel Mashaki Ceyhan,Stuart Walker,Hacer Coşkun,Oğuzhan Koyuncu,Ali Alkan

doi:10.3389/fphar.2018.00009

Abstract

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals.Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA).Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized.Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other authorities, thus avoiding the delays by the current process; removing the requirement for prior approval or CPP; introducing shared or joint reviews with other similar regulatory authorities; formally implementing and monitoring GRevP; defining target timing for each review milestone; redefining the pricing process; and improving transparency by developing publicly available summaries for the basis of approval.

Highlights

Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics
The comparison of various international regulatory systems and review processes can facilitate the identification of weaknesses and the sharing of best practices that may assist in overcoming some of these barriers
As the second largest pharmaceutical market in Central/Eastern Europe (United States Department of Commerce, 2016), the Turkish regulatory health authority Türkiye Ilaç ve Tibbi Cihaz Kurumu (TITCK) has sought over the past several decades to align its standards with those of other mature developed health agencies in order to ensure patients’ timely access to medicines

Summary

Introduction

Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. A comparison of an agency in a country with an emerging pharmaceutical market with mature health agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) may lead to an unreasonable assessment due to the different characteristics and competencies these agencies possess. Agencies from jurisdictions with emerging pharmaceutical markets may have an interest in comparing themselves with other sized mature regulatory authorities such as Health Canada and Australia (Hashan et al, 2016)

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Results

Conclusion