The legal framework for regulatory reforms in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
No proposals for reform exist or are expected in the short term. However, minor amendments of existing laws and regulations may occur.
The Draft Regulation on the Registration, Surveillance and Tracking of Medical Devices covers procedures and principles for registration, traceability and follow-up of devices covered by:
- The Regulation on Medical Devices,
- The Regulation of Active Medical Devices on the Body,
- The In Vitro Medical Diagnostic Devices Regulation.
A Draft Guideline on Biosimilar Medical Products was released on 30 May 2017 by the Pharmaceutical Product and Medical Device Institution and the revised draft guideline was released on 11 November 2020.
2. When are they likely to come into force?
Product Safety and Technical Regulation is expected to be published on 12 March 2021.