Compliance Quarterly Türkiye

Global

Digital Health 2024

The rapid convergence of digital technologies with healthcare over the past five years (even prior to the COVID-19 pandemic) has transformed how healthcare is delivered to the masses. The promise of digital technologies continues to transform the healthcare delivery model from a traditional model based on a “one-size-fits-all” practice of medicine that was characterized by a provider-centric approach with information silos, to a new model that is focused on patient-centric treatment personalization with high data accessibility and utilization.

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Türkiye

The Turkish Pharmaceuticals and Medical Devices Authority has published Guideline on Good Distribution Practice Audits

On February 27, 2024, Turkish Pharmaceuticals and Medical Devices Authority has revised the Guideline on Good Distribution Practice (GDP) Audits, mandating that pharmaceutical businesses with permits undergo inspections to ensure compliance with GDP standards. Identified deficiencies must be remedied within a specified period, with evidence submitted to Authority. Moreover, routine controls by Provincial/District Health Directorates will document deficiencies, requiring businesses to address them within 15 days and submit proof of compliance to Authority.

Regulation on the Importation of Medical Diagnostic Kits is repealed

The Regulation on the Importation of Medical Diagnostic Kits was repealed according to an announcement by the Turkish Ministry of Trade. This regulation, which previously governed the importation procedures and standards for medical diagnostic kits, was officially repealed on May 15, 2024, signifying a change in the regulatory approach to these medical devices.