Recent Developments
The Regulation on Products Derived from Human Tissues and Cells and Related Centers has been published.
With the Regulation on Products Derived from Human Tissues and Cells and the Centers Related to These Products (“Regulation“) published in the Official Gazette dated September 4, 2025 and numbered 33007, the Ministry of Health repealed, effective as of January 1, 2026, the Regulation on Cord Blood Banking and the Regulation on the Quality and Safety of Human Tissues and Cells and the Centers Related to These Products.
The Regulation was enacted to ensure the protection of human health and dignity in the processes of diagnosing, treating and scientifically using human tissues, cells and health products derived from them; ensure fair and equal allocation and access to these products; and establish quality and safety standards. The Regulation also sets forth general principles regarding licensing/authorization, activities, facility requirements, personnel and service infrastructure standards, and inspection of centers carrying out these activities as well as biobanks that archive only biological samples obtained from humans and their associated data.
The Regulation is available here (in Turkish).
What Does the Regulation Introduce?
A. Principles regarding the types, operation and activities of centers
- The following types of centers can be operated under the Regulation:
- Tissue and cell source centers authorized to supply tissues and cells for autologous and allogeneic applications or donation
- Tissue and cell centers authorized to carry out procurement, processing-production, storage and distribution activities of tissues and cells
- Human application centers defined as “health institutions and hospitals that apply licensed tissue and cell products and advanced therapeutic medical products and hospitals that apply licensed or unlicensed tissue and cell products and advanced therapeutic medical products in experimental and treatment trial studies.
- Centers may be established by tertiary health care facilities, public institutions and organizations, natural persons, and private legal entities, either in an entire building or in a designated part of a building reserved for this purpose.
- Tissue and cell centers must be licensed by the Turkish Medicines and Medical Devices Agency (“TİTCK”) as (i) tissue and cell procurement centers (living or deceased donors), (ii) tissue and cell processing-production centers, or (iii) tissue and cell storage/distribution centers.
- Tissue and cell source centers and human application centers will be authorized by the General Directorate of Health Services (“General Directorate“) to carry out their activities and will not be licensed separately.
I. Principles regarding the activities of tissue and cell source centers
- The tissue and cell sourcing center will refer all donor candidates to a contracted procurement-licensed tissue and cell center or to a tissue and cell center designated by the Tissue and Cell Coordination Center for donor medical evaluation and tissue and cell procurement after registering them to the automation system and obtaining consent.
- The tissue and cell sourcing center will take the necessary measures to preserve the tissue and cells for the required period and under the necessary conditions to ensure their quality and safety until medical evaluation is carried out by the procurement-licensed tissue and cell center.
- All kinds of incentives and promotional activities to support the donation of human tissues and cells may be carried out, subject to authorization.
- Tissues and cells considered medical waste after surgery may be collected if the donor’s medical suitability can be documented in accordance with legislation, unless there is a declaration to the contrary.
- Tissue and cell harvesting from living donors can only be performed in hospitals, medical centers and assisted reproductive treatment centers authorized as tissue and cell resource centers.
- The procedures for informing the donor candidate and obtaining consent will be carried out by a physician, dentist or nurse authorized by the responsible person of the tissue and cell source center, provided they are not part of the human practice team.
- Appropriate information environment and conditions will be provided for prospective donors to make a free and voluntary decision. Prospective donors will be informed in detailed and clear language about the benefits and risks of donation as well as the benefits to the recipient, and be given sufficient time to decide.
- Principles of donor confidentiality will be observed for non-related donors, including blood relatives beyond the fourth degree.
- Tissue and cell harvesting from deceased donors may only be performed by hospitals authorized as tissue and cell resource centers.
- Tissues and cells may be collected from deceased donors if they have declared that they declared for treatment purposes via e-Government or Ministry of Health information systems, or if they have stated such in an official or written will or in the presence of two witnesses. Otherwise, consent may be obtained from the spouse, adult children, parents or siblings present at the time of death, or if unavailable, from any relative present. If the donor’s expressed will during their lifetime is contrary to the will of relatives, the donor’s will shall prevail.
- Unless a contrary will is presented, tissues that do not alter the appearance of the body, such as the cornea, may be collected.
- It is essential that the names of donor candidates, donors and recipients are not disclosed; the names of donors and recipients may be disclosed to their blood relatives or relatives-in-law and relatives by the decision of judicial authorities in case of necessity, in accordance with the legislation on the protection of personal data.
II. Principles regarding the activities of tissue and cell centers
- Tissue and cell centers are categorized as follows: (i) centers with procurement licenses, (ii) centers with processing-production licenses, and (iii) centers with storage and distribution licenses.
- Tissue and cell centers licensed for procurement will procure from living and deceased donors.
- Tissue and cell centers licensed for processing-production will carry out processing-production activities for tissue and cell products and advanced therapeutic medical products.
- Tissue and cell centers licensed for storage and distribution will carry out storage and distribution activities for tissue and cell products and advanced therapeutic medical products.
- Tissue and cell centers will only be able to operate using products, methods, and tissue and cell types licensed by the TİTCK.
- Entities seeking establish a tissue and cell center will apply to the provincial health directorate for preliminary permission. The application must include a petition specifying the type of license to be submitted to the TİTCK and a project file detailing physical conditions, personnel, product/activity and financing plans.
- Centers that receive preliminary permission will fulfill their obligations within one year and apply for a license and at least one field of activity related to the license. Centers that do not apply for a license within this period will have their preliminary permits revoked, unless they provide a valid excuse.
- The planning of tissue and cell centers and the evaluation of applications for prior authorization will be carried out by the TİTCK.
- Entities seeking to open a tissue and cell center will apply to the Ministry of Health through the provincial health directorate to obtain permission for at least one type of license, together with the documents listed in the Regulation. If it is determined that there are no deficiencies or nonconformities, an on-site inspection will be carried out by at least one service head, an engineer/architect, and personnel experienced in quality management to be assigned by the provincial health directorate. An evaluation report will be prepared, and following the resolution of any deficiencies, the application file together with the report will be sent to the TİTCK.
- The application file will be evaluated by the scientific advisory commission or a designated sub-committee. If deemed necessary, the report prepared as a result of the on-site examination and evaluation will be reviewed by the scientific advisory commission and submitted to the Ministry of Health as a recommendation. If approved, the Ministry of Health will issue a license certificate to the applicant and a center responsible certificate to the designated center.
- The import and export of tissues, cells and derived products can be carried out by tissue and cell centers that have obtained storage and distribution licenses from the TİTCK and by authorized human application centers.
- Tissues, cells and derived products will not be exported for banking purposes without TİTCK approval.
a. Tissue and cell centers with supply licenses
- Tissue and cell centers licensed for procurement are responsible for donor medical evaluation, procurement, initial processing and initial storage. These centers must obtain approval from the Presidency of Turkish Health Institutes (“TÜSEB“) to conduct procurement activities within Türkiye.
- Procurement of human tissue and cells from the body of a deceased donor will only be possible after legal confirmation of death.
- Tissue and cell donors will be evaluated for any medical condition that may pose risks to recipients. This evaluation includes laboratory tests, imaging and physical examinations, based on the donor’s medical and social history. If an autopsy is performed, extraction will be performed during or after the autopsy.
- Procedures to protect the health of living donors will be conducted by tissue and cell sourcing centers with adequate clinical equipment for diagnosis and treatment. The center will be responsible for protecting the life and ensuring donor safety and determining the donor’s medical suitability for tissue and cell procurement.
- Tissues and cells deemed suitable for processing-production will be transferred to a tissue and cell center with a contracted processing-production license.
b. Tissue and cell centers licensed for processing and manufacturing
- Tissue and cell centers licensed for processing-manufacturing are responsible for transforming human tissues and cells into end products suitable for distribution for clinical applications. They are also responsible for the assessment of the medical suitability of the processing and the resulting product, including the initial quarantine release, and for the quality and safety assessment of finished products prior to distribution.
c. Tissue and cell centers licensed for storage and distribution
- Tissue and cell centers with storage and distribution licenses will ensure that tissue and cell products, as well as advanced treatment medicinal products licensed or authorized by the TİTCK and procured from centers with processing-production licenses or from abroad, are stored under appropriate quality and safety standards, evaluated for medical suitability before distribution for clinical use, and distributed to human application centers.
- Tissue and cell centers with storage and distribution licenses will be responsible for the shipment of products to and from abroad.
B. Human application centers
- Human application centers shall be health institutions and hospitals that administer licensed tissue and cell products and advanced therapeutic medical products, as well as hospitals that administer licensed or unlicensed tissue and cell products and advanced therapeutic medical products in experimental and treatment trials.
- Human application centers will not be able to operate without being authorized by the General Directorate. Authorization conditions will be updated and published on the website of the General Directorate on the basis of product and medical indication.
- Hospitals authorized to procure tissues and cells from living organisms will be able to transplant tissues and cells to patients.
C. Internal and external audit
- Internal audits of the centers will be programmed and conducted by the center staff under their own responsibility.
- External audits of the centers will be conducted by competent authorities and independent certification bodies designated by the competent authorities.
- All audits will be documented and recorded in the medium specified by the competent authorities.
- Assessment audits for certification, accreditation and licensing purposes shall be carried out by competent authorities or independent certification bodies designated by competent authorities.
D. Coding, labeling and packaging
- Centers will label human tissues and cells and products derived from them in accordance with the Single European Code (or SEC) coding system for the identification and tracking of the stages of donation, procurement, processing, packaging and preparation for storage, in a way that preserves their function, storage and distribution. These codes will include materials, documents, test samples and all items deemed necessary for traceability.
- The labeling system will include donor information, processing date, product type, batch and lot number, shelf life, and storage conditions; labels will contain biological risk and use warnings.
E. Prohibitions and administrative sanctions
- Activities within the scope of the Regulation shall not be carried out without a license. If unlicensed activities are detected, such activities will be stopped immediately and a criminal complaint will be filed.
- If centers are found to be in violation of the provisions of the Regulation during inspections, the center’s authorization certificate/license certificate or all or some of the types of activity permits in the license may be canceled or suspended, provided that the violation is confirmed by the inspection detection report.
- Centers may not modify their activities without prior approval from the competent authority. Any changes to the building, equipment or personnel that conflict with the conditions of the license granted for the specific type of activity are strictly prohibited.
- No center that is not licensed/authorized by the competent authority will be able to make determinations regarding medical suitability for donation, procurement, processing and distribution.
- Human tissue and cell products shall not be advertised in any way. Activities that are not based on scientific data, are misleading and panic-inducing shall not be carried out. Additionally, nor promotional claims may be made through communication channels such as television, newspapers and social media.
- Non-advertising promotions and information about the products, names and application results used in individual or organizations studies shall not be shared without reporting the application results and without permission.
- Except as permitted under the Regulation, donor candidates will not be able to receive financial compensation or similar benefits, and the need or availability of tissues and cells will not be announced for this purpose.
- Centers will not be able to conduct their administrative and financial activities in a way that will lead to commercial exploitation of tissues and cells.
- Tissues and cells outside the scope of the Regulation cannot be procured, and human tissues and cells cannot be imported or exported from Türkiye without permission from TİTCK.
- Centers will not be able to delegate their authority to anyone else.
- Ordinary and extraordinary audits to be carried out at the centers are carried out at least once a calendar year, in accordance with the audit and sanction guide to be issued by the competent authorities.
F. National Biovigilance System
- The Ministry of Health will establish the National Biovigilance System to implement necessary measures for reporting unintended adverse effects, unintended adverse events, and complications that arise – or may arise – in the clinical application of products at the local, regional, national or international levels.
G. National tissue and cell reserve
- A national reserve of tissue and cell products will be established for natural and man-made disasters such as earthquakes, industrial accidents, war, or urgent demand for military activities.
Conclusion
The Regulation introduces important innovations across various areas, including the licensing and authorization processes for centers, donor rights, audit mechanisms, coding and labeling standards, and the establishment of the national biovigilance system. It is essential that all stakeholders in the sector closely follow the new obligations and implementation principles introduced by the Regulation, as well as the guidelines and directives to be issued by the Ministry of Health and other relevant institutions in the coming period.
