The Regulation on Products Derived from Human Tissues and Cells and Centers Concerning These Products, published in the Official Gazette dated 4 September 2025 (No. 33007), marks a major regulatory shift in Türkiye’s healthcare and biotechnology compliance framework. This new regulation introduces comprehensive quality, safety, licensing, authorization, inspection, and data governance standards for tissue and cell centers, biobanks, and human application facilities. It also repeals previous fragmented legislation and establishes a unified regulatory regime governing the production, storage, distribution, export, and clinical use of human-origin biological products. In this article, we provide a structured legal analysis of the Regulation, explain the roles of competent authorities, outline the key compliance obligations for healthcare operators, and assess the operational and investment implications for institutions operating in the life sciences and medical sectors.

For the whole text take a look at our website 
https://www.pilc.law/regulation-on-products-derived-from-human-tissues-and-cells/

Comments

  1. Dr. Kutlay TelliFebruary 10, 2026 at 10:46 PM

    a new era is staring in Turkey health care field. The new Regulation hopefully will fulfill the gaps for the lack of any regulation about medical laboratories

    ReplyDelete
    Replies
    1. emre fatihFebruary 10, 2026 at 11:04 PM

      a new term for Turkey healthcare sector about medical laboratories...

      Delete
  2. Büşra DereliFebruary 10, 2026 at 11:06 PM

    Such a comprehensive article ! Valuable work, thank you

    ReplyDelete

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