Türkiye’s Emerging Role in Clinical Research: Regulatory Updates and Simplified Processes
With a population exceeding 85 million and a robust, comprehensive healthcare infrastructure, Türkiye has quietly established itself as an undiscovered treasure in the field of clinical research. With a relatively low per capita number of clinical trials and a substantial pool of treatment-naive patients, Türkiye is witnessing a surge in engagement from biotech and pharma companies, leading to a doubling of clinical trial volumes over the last three years.
The Turkish Medicines and Medical Devices Agency (TMMDA) stands as the primary regulatory body overseeing clinical trials in the country. Tasked with monitoring and evaluating human medicine trials, the TMMDA ensures their safety and compliance with international standards, including EC 2001/20 and EC 2005/28. Notably, the TMMDA is actively engaged in simplifying and expediting various regulatory processes, aligning with established practices in the European Union.
Key Changes
Recent regulatory updates in Türkiye underscore a commitment to excellence and global alignment, introducing several key changes:
- Updated Definitions: Precise refinements to the definitions of Clinical Trial and Clinical Study.
- Expanded Medicinal Product Definition: Inclusion of the definition for an authorized medicinal product for human use.
- IMPD Mandate: Introduction of the Investigational Medicinal Product Dossier (IMPD) as a mandatory submission document.
- Risk-Benefit Report Requirement: The incorporation of a requirement for a comprehensive risk-benefit report.
- Mandatory Paediatric Planning Report: A mandate for the submission of a Paediatric Planning Report.
- Phase 1 Unit Distinctions: Clear distinctions for Phase 1 Unit requirements concerning healthy volunteers and specific disease volunteers.
- Timely Revision Responses: Stipulation that all Ethics Committee (EC) and Ministry of Health (MoH) revision responses be submitted within 30 business days, or else documents should be treated as a new package.
- Global Safety Reporting: In addition to local SUSARs, globally reported safety reports should be submitted to both EC and Regulatory Authorities (RA).
- Enhanced Ethics Committee Structure: Ethics Committees now require Alternate Members corresponding to each member, with Principal Members’ signatures mandated on all EC decision letters. In the absence of the Principal member, the Alternate Member assumes the responsibility of signing EC decision letters.
- Provincial EC Empowerment: The Provincial Directorate of Health gains the authority to establish ECs in local provinces.
- Multiple Clinical Trial ECs: Permission granted for the establishment of multiple Clinical Trial ECs under a single institution.
- Member Assignment Protocol: EC members are to be assigned by the Board of Members in Universities, Head doctors in State Hospitals, and Heads of Provincial Directorate of Health in provinces.
- Simplified Mandatory Membership: The mandatory membership of ECs is streamlined, with Biostatistician, Biophysics, Biomedical, and Epidemiologist members no longer mandatory.
- National Coordinator Authority: In cities with both Head of Provincial Directorate EC and Institution EC, the National Coordinator has the right to select one.
- Distinguished Responsibilities: Clear distinctions made between the responsibilities of Clinical Research Ethics Committees and Academic Research Ethics Committees.
In a notable development in September 2023, State Hospitals in Türkiye optimized contract approval procedures by consolidating a previously two-step process into a single step. This exclusive change for State and City Hospitals reflects Türkiye’s dedication to efficiency and innovation in clinical research.
Significant enhancements in regulatory aspects and improvements in contractual processes with medical institutions make Türkiye increasingly attractive for conducting clinical trials. If you are contemplating clinical trials in Türkiye, the Cromos Pharma team stands ready to address any inquiries you may have.
