The announcements published by the Turkish Medicines and Medical Devices Agency (“TİTCK”) between 19 January and 26 January 2026 include important updates regarding the importation of tissue and cell products, advanced therapy medicinal products, clinical research, pharmaceutical pricing, and medical device legislation.
Through the various announcements published between 19 January and 26 January, 2026, the Turkish Medicines and Medical Devices Agency has issued regulations and information closely concerning stakeholders operating in the fields of pharmaceuticals, medical devices, and clinical research.
- With the announcement dated 26 January 2026, it was announced that the Guideline on Import Applications for Human-Origin Tissues and Cells and Products Derived Therefrom was published and entered into force on 23 January 2026. Accordingly, where a request is made for an invoice annotation approval letter prior to the importation of human-origin tissues and cells and products derived therefrom that are registered by the General Directorate of Health Services, applications must be submitted to the Turkish Medicines and Medical Devices Agency in accordance with the provisions of the relevant Guideline. In addition, companies holding a Tissue and Cell Center Activity Permit are required to complete company registration in the Electronic Application and Process Management System prior to submitting their applications.
- With another announcement dated the same date, it was announced that the ‘Clinical Practice Guideline’, which was prepared with the aim of ensuring accessibility to regenerative medicine practices that may be carried out using advanced therapy medicinal products, was published and entered into force on 23 January 2026. The said Guideline aims to ensure that advanced therapy medicinal products are used for the benefit of patients in need in Türkiye, in parallel with scientific and technological developments.
- Within the scope of another announcement dated 26 January 2026, it was announced that the Guideline on the Standard Operating Procedures of Ethics Committees for Clinical Research and Bioavailability/Bioequivalence Studies was updated and entered into force as of 23 January 2026. The update aims to ensure uniformity in practice with respect to the working procedures and principles of ethics committees in clinical research and bioavailability/bioequivalence studies.
- With the announcement dated 23 January 2026, it was announced that the Reference-Based Pharmaceutical Price List, which is publicly published by the Turkish Medicines and Medical Devices Agency, will be updated for the year 2026. Marketing authorization holder companies requesting the publication of their products in the said list are required to submit their applications by selecting the document type ‘Application for Publication in the Reference Price List’ between 26 January 2026 and 6 February 2026; and to submit, as an attachment to the application, a document containing the list of products requested to be published together with a petition signed by the authorized representative of the company granting consent for the public disclosure of personal data.
- With the announcement dated 19 January 2026, it was announced that, within the scope of the Regulation on the Procurement of Medicines from Abroad, it is aimed to systematically conduct and publish real-world data and pharmacoeconomic analyses regarding medicines procured from abroad. Within this scope, it is envisaged that the said studies will be completed by January 2027 at the latest, and that the data to be obtained will guide clinical effectiveness, safety, cost management, and future marketing authorization and reimbursement policies.
Finally, with another announcement dated 19 January 2026, the public consultation process initiated by the European Commission regarding the targeted revisions envisaged under EU legislation on medical devices and in vitro diagnostic medical devices was announced, and it was stated that the relevant stakeholders may submit their opinions until 10 March 2026.
