As you are aware, the Regulation on Clinical Trials of Human Medicinal Products was published in the Official Gazette dated May 27, 2023, and numbered 32203, and entered into force. The "Regulation Amending the Regulation" related to the aforementioned Regulation was published in the Official Gazette dated June 5, 2025, and numbered 32921, and entered into force.

However, in order to ensure compliance with international standards in safety reporting conducted in clinical trials, the National SUSAR Module has been developed as a sub-module within the Clinical Trials Module; accordingly, the "Guideline on Safety Reports in Clinical Trials" has been updated.

In light of these developments, there was a need to update the "Guidelines Regarding Clinical Research Applications Submitted to the Turkish Medicines and Medical Devices Agency, Department of Clinical Research" and the "Guidelines Regarding Clinical Research Applications Submitted to Ethics Committees". The updated guidelines were published and entered into force on May 15, 2026.

These guidelines can be accessed under the "Legislation" heading at https://www.titck.gov.tr/faaliyetalanlari/ilac/klinik-arastirmalar .

This is an important announcement for all concerned parties.