Recent Developments
The Turkish Medicines and Medical Devices Agency (TİTCK) recently announced changes to the clinical research process. As of January 19, 2017, certain documents requested during clinical research applications are no longer required. A list of the documents that are no longer required is included in the announcement, which is available at here (in Turkish). Additionally, the TİTCK announced a further requirement for use of biological materials in clinical research. In pursuance with the amendments made to Article 34 of the Medical Laboratories Regulation, human-derived biological materials used in clinical research should be relayed through a licensed medical laboratory by using the software for sample transfers at http://numunetransfer.saglik.gov.tr.
Background
Clinical research is defined as a scientific study that aims to obtain medical information with the participation of volunteers. Clinical research determines the safety, effectiveness, and side effects of new medicines and medical devices before they are made available to the general population, as well as provides scientific information about the development of new treatment methods. The TİTCK receives and reviews applications for clinical research and the Ministry of Health grants permission for the conduct of research. The Medical Laboratories Regulation provides that during the clinical research, only the licensed medical laboratories have the authority to send samples for examination abroad, and the entry and exit of human-derived biological samples into and from Turkey will be carried out with the permission of the Ministry of Health.
Conclusion
Companies engaging in clinical research should review the TİTCK’s website to ensure compliance with the new requirements on clinical research.
