The “Regulation on Products Derived from Human Tissues and Cells and the Centers Related to These Products” (“Regulation”) has been published in the Official Gazette dated 04.09.2025 and numbered 33007 and with this Regulation, the “Regulation on Cord Blood Banking” and the “Regulation on the Quality and Safety of Human Tissues and Cells and the Centers Related Thereto” have been repealed.
The Regulation sets forth the general principles regarding the fair and equal allocation and access, as well as the establishment of quality and safety standards, in order to ensure the protection of human health and dignity at every stage of the process concerning human tissues and cells, and the products derived from them for diagnostic, therapeutic, and scientific purposes. Furthermore, it regulates the licensing/authorization, operations, facility, personnel and service infrastructure standards, as well as the supervision of centers and biobanks where biological samples obtained solely from humans and the data related thereto are archived.
The Regulation covers a range of activities including (i) the entire processes of procurement, testing, processing, preservation, storage, and banking, distribution, destruction when necessary, and transportation of human tissues and cells, as well as their application to humans, importation from abroad, and exportation; the monitoring systems related to these processes; and the centers carrying out such operations; together with issues concerning the clinical use of human tissues and cells and products derived therefrom, the planning and approval processes of experimental studies and therapeutic trials, and (ii) the collection of human biological materials and related information within the scope of biobanking activities, their storage, processing, and other defined processes and organizations for clinical application purposes. However, the Regulation does not cover the collection, processing, and storage of tissues and cells solely for use in scientific research without clinical application purposes.
The planning of tissue and cell centers, the evaluation of preliminary permit applications, licensing, all operational permits of these centers, as well as the preliminary permit, licensing, and inspection procedures of therapeutic biobanks, and the preliminary permit, licensing, and inspection procedures of tissue and cell centers engaged in biobanking activities in this field are carried out by the Turkish Medicines and Medical Devices Agency (“TMMDA”). The authorization procedures of tissue and cell source centers and application-to-human centers are carried out by the General Directorate of Healthcare Services.
Pursuant to the Regulation, a Tissue and Cell Coordination Center will be established by the Ministry of Health in order to record through a central automation system the procurement and processing of human tissues and cells within Türkiye, the distribution and application of tissue and cell products and advanced therapy medicinal products, the monitoring and control of stock levels, as well as their import and export, and to enable the competent authorities to monitor these processes instantly through a secure automation infrastructure. The Turkish Health Institutes Presidency (“THIP”) will be the competent authority responsible for carrying out these tasks and procedures, and the principles and procedures regarding such tasks and procedures will be determined by THIP.
Within the scope of this Regulation, the following centers (collectively referred to as the “Centers”) may be established:
A- Tissue and Cell Source Center
B- Tissue and Cell Center
C- Human Application Center
General provisions regarding these Centers are set out in the Regulation as follows:
- The Centers may be established by tertiary healthcare institutions, public institutions and organizations, as well as natural persons and private legal entities, either in an entire building or in a section of a building allocated specifically for this purpose.
- Tissue and cell centers shall be licensed by the TMMDA as tissue and cell procurement centers (from living or deceased donors), tissue and cell processing/production centers, or tissue and cell storage/distribution centers.
- Tissue and cell source centers and human application centers shall be authorized by the General Directorate of Healthcare Services to carry out their activities and are not subject to a separate licensing procedure.
- The establishment, authorization, monitoring, inspection, and closure of the Centers shall be carried out by the competent authorities.
A- Tissue and Cell Source Centers and Their Activities:
The Regulation sets out in detail the following matters regarding tissue and cell source centers and their activities:
(i) the service standards that tissue and cell source centers must comply with while carrying out their activities,
(ii) the requirements to be observed in activities concerning living donors,
(iii) the requirements to be observed in activities concerning deceased donors,
(iv) the personnel that must be employed at a tissue and cell source center and their respective duties,
(v) the obligation of tissue and cell source centers to provide information.
B- Tissue and Cell Centers and Their Activities:
Pursuant to the Regulation, tissue and cell centers are facilities that carry out the procurement, processing/production, storage, and distribution of tissues and cells.
The Regulation sets out in detail the following matters regarding tissue and cell centers and their activities:
(i) the personnel required to be employed at a tissue and cell center, their qualifications, and duties,
(ii) the types of licenses for tissue and cell centers,
(iii) the activities that may be conducted depending on the license type of the tissue and cell centers,
(iv) the granting of preliminary permits to tissue and cell centers,
(v) the license application procedures of tissue and cell centers and the information and documents to be submitted with such applications,
(vi) the obligations of tissue and cell centers.
In addition, the Regulation also contains detailed provisions regarding the following types of licenses that may be granted to tissue and cell centers:
- tissue and cell centers licensed for procurement
- tissue and cell centers licensed for processing/production
- tissue and cell centers licensed for storage and distribution
C- Human Application Centers and Their Activities:
Pursuant to the Regulation, human application centers are healthcare institutions and hospitals that administer licensed tissue and cell products as well as advanced therapy medicinal products, and hospitals that administer licensed or unlicensed tissues and cells and advanced therapy medicinal products in experimental studies and therapeutic trials.
The Regulation sets out in detail the personnel required to be employed in a human application center and their respective duties.
In addition to the above, the Regulation contains detailed provisions regarding the matters that Centers must comply with while carrying out their activities, including: (i) quality management system, (ii) organization, personnel, and training, (iii) environment, equipment, and materials, (iv) device maintenance and calibration, (v) material management, (vi) validation and qualification, (vii) safety measures, (viii) internal and external audits, (ix) risk management, (x) continuity planning, (xi) change control, (xii) coding, labeling, and packaging, (xiii) traceability, data retention, and confidentiality, and (xiv) third parties.
The Regulation also regulates product returns, recall, and disposal procedures.
Furthermore, pursuant to the Regulation, a national reserve of tissue and cell products shall be established for situations requiring urgent demand related to natural and man-made disasters or military activities, such as earthquakes, industrial accidents, or war. The determination of national needs and the procedures for maintaining the national reserve shall be set by the Ministry of Health.
The import and export procedures for tissue and cell products and advanced therapy medicinal products shall be determined through guidelines, manuals, and other secondary regulations to be issued by the competent authority.
Prohibited acts under the Regulation are as follows:
- Activities within the scope of the Regulation may not be carried out without a license.
- Centers may not make changes in their activities without obtaining authorization from the competent authority.
- Centers may not make changes to buildings, equipment, or personnel contrary to the licensing conditions obtained under the applicable regulations for their type of activity.
- No center that has not been licensed/authorized by the competent authority may issue a medical suitability decision for donation, procurement, processing, or distribution, nor may it conduct any of the activities falling within the scope of this Regulation, including import and export.
- No advertising may be made in any form regarding human tissue and cell products. Activities that are not based on scientific data and that mislead, cause panic, or misinform the public are prohibited. It is also forbidden to make promising statements through communication channels such as television, newspapers, or social media in relation thereto.
- Promotional and informational activities that are not of an advertising nature regarding the products, names, and application results falling within the scope of this Regulation may not be carried out without first obtaining permission from the competent authority and without reporting the application results.
- Donor candidates may not obtain financial gain or similar advantages, except as expressly permitted by this Regulation. Announcements regarding the need for or availability of tissues and cells for such purposes are prohibited.
- Centers may not conduct their administrative or financial relations in a manner that would lead to the commercial exploitation of tissues and cells.
- The procurement of tissues and cells that fall outside the scope of this Regulation is prohibited.
- Persons or entities who have not obtained authorization from the competent authority may not export or import human tissues and cells.
- Centers may not transfer their authorities to another party.
In this respect, if unlicensed activities are detected, such activities shall be immediately suspended and a criminal complaint shall be filed. In cases where inspections conducted by the Ministry of Health reveal that the Centers are engaged in activities contrary to the provisions of this Regulation, the authorization/license certificate of the center, or all or part of the activity permissions specified in the license, may be revoked or suspended, provided that such findings are substantiated by an inspection report. Furthermore, those engaging in activities in violation of the provisions of the Regulation shall be subject, depending on the nature of their acts, to the applicable provisions of the Turkish Criminal Code, the Fundamental Law on Health Services, the Public Health Law, and other relevant legislation.
The Regulation will enter into force on 01.01.2026. Centers operating prior to the effective date of this Regulation are required to bring their facilities and activities into compliance with the provisions of this Regulation within one (1) year from 01.01.2026.
You may access this Regulation through this link.