Regulation On Products Derived From Human Tissues And Cells

Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products Circuited [İnsan Doku ve Hücrelerinden Elde Edilen Ürünler ve Bu Ürünler ile İlgili Merkezler Hakkında Yönetmelik] was published in the Official Gazette dated September 4, 2025 and numbered 33007. Please visit the official website of the Official Gazette here.

Introduction

Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products was published in the Official Gazette dated September 4, 2025 and numbered 33007. The available article will shed light on the new Regulation and potential implications for the way forward.

What is the aim of the Regulation on Products Derived from Human Tissues, Cells and Centers?

It is useful to indicate at the outset that the main purpose of this Regulation is to establish quality and safety standards and to ensure fair and equal allocation and access, while safeguarding human health and dignity at every stage of the process, with respect to human-origin tissues and cells and products derived therefrom intended for diagnostic, therapeutic, and scientific use. Through the new Regulation, the Regulation on Cord Blood Banking published in the Official Gazette dated 5 July 2005 and numbered 25866, and the Regulation on the Quality and Safety of Human Tissues and Cells and the Centers Related Thereto [5/7/2005 tarihli ve 25866 sayılı Resmî Gazete'de yayımlanan Kordon Kanı Bankacılığı Yönetmeliği ile 27/10/2010 tarihli ve 27742 sayılı Resmî Gazete'de yayımlanan İnsan Doku ve Hücreleri ile Bunlarla İlgili Merkezlerin Kalite ve Güvenliği Hakkında Yönetmelik] was published in the Official Gazette dated 27 October 2010 and numbered 27742, have been repealed.

This Regulation also sets forth the general principles governing the licensing/authorization, activities, facility, personnel, and service infrastructure standards, as well as the inspection of centers and biobanks in which exclusively human-derived biological samples and the data related thereto are archived

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Who are the Authorized Authorities under the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products

The Authorized Authorities are described under the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products.

There are three competent authorities responsible for the procedures set forth in the Regulation.

• The General Directorate of Health Services [Sağlık Hizmetleri Genel Müdürlüğü in Turkish],
• The Turkish Medicines and Medical Devices Agency [Türkiye İlaç ve Tıbbî Cihaz Kurumu],
• The TÜSEB [Türkiye Sağlık Enstitüleri Başkanlığı in Turkish]
• Under the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products,
• The planning of tissue and cell centers and the evaluation of preliminary authorization applications [ön izin başvuruları in Turkish] shall be carried out by the Turkish Medicines and Medical Devices Agency,
• The authorization procedures[yetkilendirme işlemleri in Turkish] of tissue and cell source centers and human application centers shall be conducted by the General Directorate of Health Services,
• The licensing of tissue and cell centers, all activity permits of these centers, and any additions related to tissue and cell products [ön izin, ruhsatlandırma ve denetim işlemleri in Turkish]shall be carried out by the Turkish Medicines and Medical Devices Agency.
• The preliminary authorization, licensing, and inspection of therapeutic biobanks, as well as the preliminary authorization, licensing, and inspection of tissue and cell centers engaged in biobanking activities in this field [ön izin, ruhsatlandırma ve denetim in Turkish]shall be carried out by the Turkish Medicines and Medical Devices Agency.

What are the Main Obligations of Tissue and Cell Centers under the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products?

Under Article 21, obligations of Tissue and Cell Centers are formulated in detailed manner. In this context, the import and export activities of tissues, cells, and products derived therefrom may be carried out solely by tissue and cell centers that have obtained a storage and distribution license for such activities from the competent authority, as well as by authorized human application centers,

In terms of data impact assessment, the said Regulation fills out previous gaps for data transfer abroad. Indeed, in accordance with Article 21, Tissues, cells, and products derived therefrom cannot be exported abroad for the purpose of storage within the scope of biobanking activities unless deemed appropriate by the competent authority.

Additionally, centers keeping personal data relating to tissue and cell donors and recipients are obligated, when sharing personal data concerning institutions, authorized persons, donors, and recipients with third parties, to anonymize such data and to keep identity information confidential.

What is more, centers are obliged to conduct internal audits twice a year in accordance with the audit and sanction guideline to be issued pursuant to this Regulation,

Which Centers can be Opened under the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products?

The centers that may be established within the scope of this Regulation are as follows:

• Tissue and cell source center.
• Tissue and cell center.
• Human application center.

Conclusion

Having regard to the above, the Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products brought significant amendments in fulfilling the previous gaps for the compliance of certain healthcare activities. Indeed the said Regulation addresses the general principles governing the licensing/authorization, activities, facility, personnel, and service infrastructure standards, as well as the inspection of centers and biobanks in which exclusively human-derived biological samples and the data related thereto are archived.

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.