Turkey offers substantial opportunities for foreign pharmaceutical and medical device manufacturers, driven by economic growth, Free Healthcare Zones, and increasing demand for advanced healthcare solutions.
The Turkish Ministry of Health, through the Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK), oversees the regulation of medicines, medical devices, and cosmetics, handling market authorizations, registrations, clinical trials, and post-market surveillance. Turkey has aligned its medical device regulations closely with EU MDR/IVDR standards, creating both opportunities and challenges for global companies entering the market. MedWisdom LifeScience serves as a dedicated regulatory partner, providing expert guidance and comprehensive support to design effective compliance strategies, navigate local requirements, secure timely approvals, and achieve successful, sustainable market access in Turkey.
Get Turkey Compliance Support
End-to-end support for TİTCK marketing authorization applications for medicines and medical devices, including national and EU-aligned pathways.
Comprehensive post-approval management including variations, renewals, line extensions, and ongoing compliance with TİTCK requirements.
Preparation, validation, and submission of regulatory dossiers to TİTCK, including follow-up and query responses throughout the review process.
Development and review of Bioequivalence/Bioavailability reports, Summary of Product Characteristics (SmPC), and Patient Information Leaflets (PIL) in Turkish.
Full eCTD dossier compilation, technical validation, and electronic submission support compliant with TİTCK and EU standards.
Compilation, maintenance, and updating of Product Information Files for cosmetics and borderline products per Turkish regulations.
Acting as local authorized representative, TİTCK liaison, and legal contact point for foreign manufacturers in Turkey.
Preparation and submission of clinical trial applications to TİTCK and ethics committees, including protocol support and regulatory follow-up.
PMS/PMSR implementation, vigilance reporting, field safety notices, trend analysis, and compliance with Turkish post-market requirements.
Turkish labeling review, artwork preparation, readability testing, and compliance with TİTCK-specific packaging and information requirements.
Customized training programs, workshops on TİTCK processes, and ongoing advisory support for internal teams and local partners.
Development and maintenance of Risk Management Plans (RMP), risk-benefit evaluations, and proactive risk mitigation strategies per TİTCK guidelines.
Partner with Medwisdom for expert, comprehensive, and compliant regulatory support in Turkey — from TİTCK market authorizations and eCTD submissions to lifecycle management, post-market surveillance, and long-term success.
Contact Our Turkey Regulatory Experts