TİTCK Submission & Approval Process
Submission Preparation
Comprehensive compilation of the clinical study dossier, including the study protocol, Investigator’s Brochure (IB), participant Informed Consent Forms (ICFs), and required insurance documentation. Our experts ensure full alignment with TİTCK’s specific technical guidelines and Turkish GCP standards before first-line filing.
Ethics Committee Review
- Central & Local Committee Filing
- Patient Safety & Rights Assessment
- Scientific Rigor Validation
The Ethics Committee evaluates the ethical integrity and scientific merit of the trial. In Turkey, approvals are typically processed within 15 to 30 days, providing a critical foundation for subsequent regulatory authorization.
TİTCK Final Approval
Following favorable Ethics Committee results, the final application is submitted to the Turkish Medicines and Medical Devices Agency (TİTCK) via the EBS/E-Signature system. TİTCK conducts a high-level review of the trial site feasibility and investigator qualifications before issuing the official Authorization Letter.
Strategic Compliance and TİTCK Regulatory Framework
Agency Approval (TİTCK): All clinical trials involving pharmaceuticals, biological products, and medical devices must receive authorization from the Turkish Medicines and Medical Devices Agency before initiation.
Ethics Committee (EC) Governance: Concurrent local ethics committee review is mandatory, ensuring trials align with the Declaration of Helsinki and local participant protection statutes.
MDR & IVDR Regulatory Alignment: Specialized dossiers for medical device and in-vitro diagnostic investigations, optimized for the Turkish market's full integration with European medical device regulations.
Logistics & Import Management: Comprehensive handling of import permits for Investigational Medicinal Products (IMP) and biological sample export authorizations from agency divisions.
Post-Approval Monitoring and Reporting
PHARMACOVIGILANCE MONITORING
Continuous evaluation of drug safety profiles and ADR reporting in strict compliance with Turkish Ministry of Health standards.
PERIODIC SAFETY REPORTS
Preparation and timely submission of PSURs and PBRERs reflecting global and local birth dates for ongoing TİTCK review.
POST-MARKET SURVEILLANCE
Strategic management of observational studies and real-world evidence gathering for long-term therapeutic efficacy assessment.
VARIATION LIFECYCLE
Agile management of CMC and safety variations, ensuring all product updates remain fully aligned with TİTCK requirements.
The Regulatory Framework and TİTCK Navigation in Turkey
Turkey’s life sciences regulatory landscape is governed primarily by the Turkish Medicines and Medical Devices Agency (TİTCK). This framework ensures that pharmaceutical products and medical devices meet rigorous international benchmarks, maintaining standards that are strictly harmonized with European Union directives and ICH-GCP quality guidelines.
- Digital Pathway Mastery: All dossiers are processed via the TİTCK Electronic Submission System (EBS), which requires proprietary encryption and technical certification for valid submissions.
- Dual Approval Requirements: Clinical trials follow a parallel review pathway, requiring permissions from both the central TİTCK authority and specialized Ethics Committees.
- Strategic Representation: CROTURK serves as the local legal representative for international sponsors, bridging technical administrative gaps and serving as the primary liaison for Turkish officials.
By merging deep local legislative knowledge with technical expertise, CROTURK simplifies the TİTCK authorization cycle. Our end-to-end management significantly reduces site activation timelines, providing European sponsors with a transparent and reliable route to Turkey’s high-volume clinical research centers.
Expert Navigation of TİTCK Regulatory Processes
Turkey's pharmaceutical and medtech landscape is governed by specific TİTCK (Turkish Medicines and Medical Devices Agency) statutes that align with international standards while maintaining unique local milestones. Our specialized consultants bridge the gap for global sponsors, providing the localized intelligence needed to successfully navigate the Regulation on Clinical Trials and market entry requirements.
- TİTCK Clinical Trial Authorization & Licensing
- National & Ethics Committee submission management
- EU MDR / IVDR local adaptations & technical audits
- Pharmacovigilance and local product representation
- Market access mapping and regulatory feasibility reports