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Regulation on Products Derived from Human Tissues and Cells and Centres Related to These Products ("Regulation") has been published in the Official Gazette number 33007 dated 4 September 2025, and by the Ministry of Health.
The primary purpose of the Regulation is to ensure the protection of human health and dignity in the use of products obtained from human-derived tissues and cells for diagnostic, therapeutic, and scientific purposes. The regulation sets standards for the procurement, testing, processing, storage, distribution, and use of these related products by adopting the principles of quality, safety, fair, and equal access at every stage of these processes. Additionally, it covers the principles related to the licensing, regulation of activities, establishment of infrastructure and personnel standards, and inspection of centers operating with these products.
The procedures and principles regarding the activities of organizations engaged in the production, import-export, storage, and distribution of human tissues and cells, as well as the licensing of human tissue and cell products, were regulated under the Communiqué on the Licensing of Human Tissue and Cell Products and Centers Conducting Production, Import, Export, Storage, and Distribution Activities of These Products, published in the Official Gazette number 28962 dated 4 April 2014. However, with the enforcement of the Regulation and the Communiqué on the Abrogation of the Communiqué on the Licensing of Human Tissue and Cell Products and Centers Conducting Production, Import, Export, Storage, and Distribution Activities of These Products ("Communiqué"), published in the Official Gazette number 33007dated 4 September 2025 and, the Communiqué on the Licensing of Human Tissue and Cell Products and Centers Conducting Production, Import, Export, Storage, and Distribution Activities of These Products, published in the Official Gazette number 28962 dated 4 April 2014 and was repealed.
In terms of scope, the Regulation governs the processes of procurement, processing, storage, transportation, and application to humans of human tissues and cells. Additionally, it covers biobanking activities, the procurement and processing of cells used in assisted reproductive technologies, processes related to bone marrow-derived stem cells, and cornea banking. However, the Regulation does not cover the licensing of bone marrow transplant and assisted reproductive treatment centers, blood banking and plasma fraction products, organ transplantation, animal and synthetic tissue products, or products falling within the scope of the medical device regulation.
The Regulation has been prepared in accordance with Law No. 2238 on Organs and Tissues, Law No. 3359 on Basic Health Services, and related Presidential decrees. Furthermore, basic concepts and terms used in the Regulation are clearly defined to ensure clarity in its application. These definitions cover a wide range, from the methods of processing tissues and cells to the operation of biobanks; from allogeneic and autologous applications to advanced therapeutic medicinal products.
The second section of the Regulation regulates the structure, duties, and working procedures of authorized bodies and commissions responsible for managing processes related to human tissues and cells. Within this scope, the Turkish Medicines and Medical Devices Agency, the General Directorate of Health Services, and the Turkish Health Institutes Presidency have been designated as the main authorized bodies. The Regulation also foresees the establishment of the "Tissue and Cell Coordination Commission" for the determination of ethical principles in the field of tissues and cells, the development of new treatment methods, the enhancement of product diversity, as well as for the adoption of scientific developments and strategic decisions.
The Regulation also sets forth the types of centers in which the processing, storage, and transfer of products derived from human tissues and cells are carried out, as well as the licensing procedures for such centers. It is mandatory to ensure factors set out in the Regulation such as the technical equipment, personnel competencies, information disclosure obligations, and hygiene conditions of these centers.
Inspection and control mechanisms for the centers are also detailed in the Regulation. Additionally, the Regulation imposes comprehensive record-keeping and documentation obligations to ensure traceability of products obtained from human tissues and cells. Within this scope, the Ministry of Health will be able to digitally monitor the entire process of medical products from production to use, and it will be recorded and traceable which product is administered to which patient, where, and by whom.
In conclusion, the provisions of the Regulation outline the framework for the safe, ethical, and effective use of products derived from human tissues and cells, regulate the activities of relevant centers, and contribute to the establishment of standards and inspection mechanisms within the healthcare system.
The full text of the Regulation is available at this link, and the Communique is available at this link. (only available in Turkish).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
