The Turkish Medicines and Medical Devices Agency ("TITCK") has published a Guide on Reliance Practices in Clinical Trial Applications ("Guide") to be affective as of September 1, 2022. The purpose of the Guide is to determine the procedures and principles to be applied to inspection and evaluation of clinical trial applications in accordance with the Regulation on Clinical Trials of Pharmaceuticals and Biological Products ("Regulation").
Accordingly, in inspection and evaluation , TITCK may take into account and benefit from assessments or published reports of other pharmaceutical authorities or regional or international institutions with comparable standards. With this respect, the principle of reliance may be defined as the consideration or use of the assessments previously made by other regulatory authorities.
Principle of Reliance for Good Manufacturing Practices ("GMP") Certificate and the Production Site Permit
Pursuant to the Regulation, GMP certificate of the product subject to clinical trial is required to be submitted with the application. With the Guide, it was clarified that, regarding the GMP certificate of the production facility concerning the prouct subject to clinical trial;
- It is not requried to submit additional documentation provided the product subject to clinical trial has been granted GMP Certificate by TITCK or was produced in a facility that has a Production Site Permit given by the TITCK.
- For the products which were produced in a foreign facility, GMP Certificate and/or Production Site Permit given by the authorities of a PIC/S and ICH member state should be submitted. If such state authority publishes this documentation in a public domain, the reference number, information, or documentation to access such information would be sufficient.
- For the products for which the above-mentioned foreign authorities do not publish relevant documentation in a public domain, the signed and Apostilled GMP Certificate and/or the Production Site Permit should be submitted.
Principle of Reliance for Good Laboratory Practices ("GLP") Certificate
Preclinical pharmacotoxicological trials should be conducted in accordance with the Regulation on Principles of Good Laboratory Practices, Harmonization of Test Units, Inspection of Good Laboratory Practices and Studies published in the Official Gazette dated March 03, 2010. It was explained with the Guide that GLP Certificate given by an OECD member state should be submitted along with other required documentation as determined under the Guide for Clinical Research Applications Made to the TITCK Clinical Research Department ("Clinical Research Application Guide").
Principle of Reliance for Good Clinical Practices ("GCP") Certificate
According to the Clinical Research Application Guide, a statement that the clinical trials were conducted in accordance with GCP should be included to the application file. If deemed necessary, TITCK may request an inspection report carried out by other health authorities or TITCK may conduct GCP inspection itself.
However, as stipulated under the Regulation on Clinical Trials of Pharmaceuticals and Biological Products dated April 13, 2013, phase I clinical trials should be conducted in facilities which have been granted an official authorization upon inspection made of TITCK. As per the Guide, for phase I clinical trials conducted in facilities that were granted the official authorization by TITCK previously, the relevant documentation is not required to be submitted.
Originally published 09 September 2022.
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.