The Turkish Medicines and Medical Devices Agency ("TMMDA") has recently published new announcements and guidelines. The relevant announcements and guidelines relate to scientific advice, good manufacturing practice ("GMP") of foreign manufacturing facilities and mutual recognition of authorized representatives and recognized bodies in the field of medical devices between the European Union ("EU") and Türkiye.
Relevant announcements and guidelines are as follows:
Guidance on Scientific Advice for Medicinal Products for Human Use
The Guideline on Scientific Advice for Medicinal Products for Human Use was published on the website of the TMMDA on 15.09.2023.
The Guideline on Scientific Advice for Medicinal Products for Human Use aims to enable scientific advice to be requested from the TMMDA in order to develop new medicinal products, to promote the placing of high quality, effective and safe products on the market, and to increase efficiency in the marketing authorization process. The Guidance states that, regardless of the stage of the marketing authorization application, requests for advice may be about quality, non-clinical studies, clinical studies, any methodological issues or different designs, and the overall development strategy.
Post-authorization scientific advice can also generally be on a new formulation, pharmaceutical form or method of application, indication extension and a new manufacturing process or manufacturing process/quality changes.
On the other hand, administrative issues and questions regarding the design of ongoing clinical trials are excluded from the scientific advice procedure.
Guidance on Applications for GMP Audits of Foreign Production Facilities
The Guideline on Applications for GMP Audits of Overseas Manufacturing Facilities was updated on 18.09.2023.
In the announcement made by the TMMDA on the subject, it was stated that the documents specified in the Guideline should be checked in detail in order to avoid loss of time in the applications to be made to the Department of Medicines Inspection, Domestic Facility Inspection Application and Tracking Unit.
Announcement on Free Movement of Medical Devices between the EU and Türkiye
With the announcement published on the TMMDA's website on 19.09.2023, it was reminded that the Turkish legislation was harmonized with the EU's medical device legislation and the free movement of medical devices between the EU and Türkiye was ensured.
In this respect, it was stated that harmonization with the EU legislation was achieved with the entry into force of the Regulation on Medical Devices and the Regulation on Medical Devices for In Vitro Diagnostic Purposes in Turkish law. It was emphasized that the conformity was confirmed with the declaration of the European Commission dated 21.05.2021 in terms of medical devices and with the declaration dated 13.09.2021 in terms of in vitro diagnostic medical devices.
In light of this information, manufacturers established in the EU have no obligation to designate an authorized representative in Türkiye