Healthcare & Life Sciences Newsletter I August - September 2025

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline for Applications for GMP Inspection of Foreign Manufacturing Facilities, and updated the Guideline on the Issuance of Pharmaceutical Certificate, Free Sale Certificate, and Health & Free Sale Certificate.

Additionally, the Ministry of Health published the Regulation on Products Derived from Human Tissues and Cells and Related Centers.

Also, Presidential Decree on the Approval of the Medium‑Term Program (2026‑2028) (Decree Number: 10376) was published.

Regulation on Products Derived from Human Tissues and Cells and Related Centers

On 4 September 2025, the Ministry of Health published the Regulation on Products Derived from Human Tissues and Cells and the Centers Related to These Products (“Regulation”) and repealed the Regulation on Cord Blood Banking and the Regulation on the Quality and Safety of Human Tissues and Cells and the Centers Related to These Products effective as of 1 January 2026

The main amendments introduced by the Regulation are as follows:

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 cell

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 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.

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.

• 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.

• Tissue and cell harvesting from deceased donors may only be performed by hospitals authorized as tissue and cell resource centers.

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 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.

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.

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.

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.

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.

• Hospitals authorized to procure tissues and cells from living organisms will be able to transplant tissues and cells to patients.

Internal and external audit

• Assessment audits for certification, accreditation and licensing purposes shall be carried out by competent authorities or independent certification bodies designated by competent authorities.

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.

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.

• 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.

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.

The Regulation is available here (in Turkish) and our legal alert regarding the Regulation is available here for details.

Presidential Decree on the Approval of the Medium‑Term Program (2026‑2028) (Decree Number: 10376)

The Presidential Decree on the Approval of the Medium-Term Program (2026-2028) issued by the Ministry of Treasury and Finance and the Directorate of Strategy and Budget was published in the Official Gazette dated 7 September 2025 and numbered 33010 (bis).

The main objectives set out by the Medium-Term Program are as follows:

• Promotion of rational drug use to ensure the rationalization of pharmaceutical and treatment expenditures,

• Development of domestic medical products and technologies through research and product development activities focused on vaccines, pharmaceuticals, medical devices, diagnostic kits, and AI-based health technologies, in line with the needs of the national healthcare system,

• Enhancement of the effectiveness of primary healthcare services within the overall health system and strengthening of integration between different levels of care.

The Decree is available here (in Turkish), and our legal alert regarding the Decree is available here for details.

Guideline for Applications for GMP Inspection of Foreign Manufacturing Facilities

On 22 September 2025, the TİTCK updated the Guideline for Applications for GMP Inspection of Foreign Manufacturing Facilities (“Guideline”). The main amendments introduced by the Guideline are as follows:

• If a request is made to extend the Good Manufacturing Practice Certificate (“GMP Certificate”) for products permitted by the TİTCK following an on-site inspection or a file-based inspection at a foreign manufacturing facility, the validity period of the inspection will be 12 years as long as the facility is located in a country that is a party to the Pharmaceutical Inspection Co-operation Scheme (“PIC/S”). For applications based on on-site inspections conducted in 2016 or later, the relevant facilities will be permitted to apply for a risk-based inspection three times.

• Products with GMP Certificates that were issued following applications based on file-based or risk-based inspections will be included in the scope of the first inspection to be conducted at the facilities.

• Requests to extend the validity period of existing GMP Certificates for products that cannot meet the general principles and conditions for on-site inspection as determined by the TİTCK’s assessment, or for products whose risk-based inspection rights have been extended two or three times and that are subject to file-based inspection under the Guideline, may be submitted, provided that a current and valid GMP Certificate for the facility has been issued by the PIC/S member authorities and is included in the application. Applications made using the “Foreign Good Manufacturing Practices (GMP) Notifications” document type will be evaluated, and the validity period of the existing GMP Certificates may be extended once for up to 12 months from the expiration date.

• For requests to add non-required activities that were not inspected during the on-site inspection and are not included in the issued certificate, an application must be submitted along with certain documents, such as a local authority report that includes the relevant activities under the document type “Foreign GMP Notifications,” a report issued by PIC/S authorities, a manufacturing site license and the facility’s current GMP Certificate. A decision will be made based on an evaluation of these materials.

The Guideline is available here (in Turkish).

Guideline on the Issuance of Pharmaceutical Certificate, Free Sale Certificate, and Health & Free Sale Certificate

On 29 September 2025, the TİTCK published the Guideline on the Issuance of Pharmaceutical Certificate, Free Sale Certificate, and Health & Free Sale Certificate and repealed the Guideline on the Issuance of Pharmaceutical Certificate, Free Sale Certificate, and Pharmaceutical License Status Declaration, effective as of 15 October 2025. The Guideline sets forth the requirements to apply for the certificates included in the Guideline; the documents required for the application; examples of certificates, tables and undertakings; and the procedures and principles to be followed in the application.

The main amendments introduced by the Guideline are as follows:

• Products covered by the Pharmaceutical Certificate application now include (i) products whose license has been revoked for commercial- or health-related reasons and (ii) products for which the license application has been withdrawn by the applicant for commercial- or health-related reasons.

• The Guideline now includes the Health & Free Sale Certificate, which demonstrates that foods for special medical purposes are not harmful to human health, are suitable for human consumption and are approved for free sale in the exporting country. The relevant certificate application can be submitted for foods for special medical purposes that are licensed or authorized in Türkiye.

• The Health & Free Sale Certificate will remain valid for one year from the date it is approved by TİTCK, provided that the submitted and approved information remains unaltered.

• The person(s) authorized by the applicant shall submit the certificate applications and prepare the information and documents to be submitted to the TİTCK. The responsibility will rest with the applicant.

• The certificate will no longer be valid if there are changes in the approved information on which the certificate application was based.

• If the TİTCK requests additional information or documentation, the applicant will be responsible for providing the requested materials.

• The applicant will be responsible for ensuring the accuracy of the data entered into the TİTCK’s information management system in accordance with the requirements set forth by the TİTCK.

The Guideline is available here (in Turkish).

Conclusion

The TİTCK and the Ministry of Health continue to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s and the Ministry of Health’s announcements and take the necessary actions to ensure compliance.