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ATMP Guidelines in Türkiye: A Guide to Clinical Research and Licensing for Advanced Therapy Medicinal Products
Two core documents govern the advanced therapy medicinal products (ATMP) landscape in Türkiye, forming a complementary framework: the Regulation on the Licensing of Advanced Therapy Medicinal Products (Official Gazette 27 May 2023, No. 32203) and the...
CIOMS/ICH Glossary V10 Published: E6(R3) Annex 2 and the New Generation of Terms
Version 10 of the Glossary of ICH Terms and Definitions, compiled by CIOMS (Council for International Organizations of Medical Sciences), was published on 15 June 2026. The reference assembles approximately 1,479 definitions from 159 ICH guidelines i...
Clinical Trial Applications 2019-2025: A Record Year of 706 in Türkiye
According to the Turkish Medicines and Medical Devices Agency's (TİTCK) current statistics presentation, the number of clinical trial applications in Türkiye rose to an all-time record of 706 in 2025 — a 48% increase over seven years. Even more strik...
EMA Introduces New Regulations on Paediatric Investigation Plans
The European Medicines Agency (EMA) has announced new regulations concerning paediatric investigation plans (PIPs). These regulations aim to include children more effectively in drug development processes. Taking into account the specific needs of ch...
EMA's New Regulations on Paediatric Investigation Plans
The European Medicines Agency (EMA) has published a press release introducing new regulations and requirements for paediatric trials. These regulations are aimed, in particular, at encouraging the development of new treatment options for child patien...
FDA Approves New Treatment Using Donor Immune Cells to Prevent Serious Complications in Cancer Patients
The U.S. Food and Drug Administration (FDA) announced the approval of TREGZI, the first regulatory T (Treg) cell-based immunotherapy, aimed at improving survival without chronic graft-versus-host disease (GVHD) in cancer patients undergoing allogenei...
FDA Proposes Rule to Modernize Drug Manufacturing Records
The U.S. Food and Drug Administration (FDA) today published a proposed rule that, if finalized, would create a simplified registration pathway for distributed manufacturing facilities operating as a single establishment using a "hub-and-spoke" model....
Guideline on Site Organisation Management: How a Site Staff Member Joins a Clinical Trial Team
Finding a research nurse, data coordinator or site management professional for a clinical trial site in Türkiye is not always easy; at small and medium-sized sites, the principal investigator often carries most of the administrative load alone. TİTCK...
Rare Diseases in Türkiye: 7 Critical Numbers from the Summit-2026 Report
The *Rare Lives and Rare Diseases Summit-2026 Report*, published by the Rare Diseases Federation in March 2026, lays out the most comprehensive picture of Türkiye's rare disease ecosystem to date. The second Summit, held on 26 March 2026 in Ankara, b...
TİTCK Legislation Interpretation: When Does Insurance Exemption Apply in Clinical Trial Applications, and How Does the Process Work?
Under the legislation of TİTCK (Turkish Medicines and Medical Devices Agency), insurance exemption may apply in certain cases during the conduct of clinical trials. Insurance exemption may be requested by the principal investigator of the trial in ca...