Turkish Pharmaceuticals and Medical Devices Agency (“TITCK”) Medicine Audit Agency published the Guideline for the Risk-Based Good Clinical Practice Audits (“Guideline”) on 8 August 2022.
The Guideline aims to define and standardize the processes related to risk-based good clinical practice (“GCP”) audits.
The most remarkable matters within the scope of the Guideline are as follows:
- The Guideline covers the clinical trials presented in the registration application, including the bioavailability / bioequivalence studies, the ongoing clinical trials, and the institutions, organizations and individuals related to these trials.
- Pursuant to the Guideline; GCP audits can be conducted for the verification of the application for registration, or for a follow-up after registration before, during or after the clinical trial is conducted.
- Any clinical research included in the license application file can be subject to audit, in this way, a GCP audit can be carried out for a specific reason or within the scope of a routine audit.
- The provisions of “Guideline on Triggers for Routine and/or for Specific Reason Inspections” and the “Guideline on Triggers for Inspections of Bioavailability / Bioequivalence Studies” will also be taken into consideration in GCP inspections to be carried out within the scope of the Guideline. You can reach our article, published in MA | Gazette dated 29 April 2022 and numbered 115, about these guidelines from this
- The Guideline states that license application, clinical research and clinical research centers can be selected for inspection in routine GCP inspections.
- Inspections for a specific reason can be requested by the evaluators due to a concern about deviations from the GCP in all clinical trials conducted with a human medicinal product or in studies conducted at a specific center during the evaluation process of the marketing authorization application.
- In the GCP audits performed within the scope of routine audits, the sponsor, contractual research institution, researcher and / or other relevant parties within the scope of the research could be informed before the planned audit date, whereas in the audits for a specific reason, a prior notice can be given, or the audit can be carried out without notice.
You can access the full text of the Guideline via this link. (only available in Turkish.)