The Regulation Amending the Regulation on Clinical Research of Pharmaceutical and Biological Products was published in Official Gazette number 29474 on 13 September 2015 ("Regulation"). Among other changes, the new Regulation removes permit requirements for clinical research centers, as well as changes requirements for ethics committee and education processes.
The Regulation makes changes to the Regulation on Clinical Research of Pharmaceutical and Biological Products (Official Gazette number 28617, 13 April 2013). Significant provisions include:
- Removing the obligation on clinical research centers to have a permit to carry out clinical research from the Turkish Drug and Medical Device Institution.
- For applications to conduct multicenter clinical research, ethics committee approval is required. Approval must be obtained from the committee located in the coordinating center's region (or closest committee to the coordinating center, if none exists within the particular region). If the research is conducted by a single center, approval must be obtained from the ethics committee located in the research center's region (or closest regional committee, if none exists within the particular region).
- Extending the deadline to 1 April 2016 for health professionals and ethics committee members to complete primary education about good clinical practice and clinical research. The ethics committees are established by the Regulation on Clinical Research of Pharmaceutical and Biological Products and approved by the Turkish Drug and Medical Device Institution.
The Regulation came into effect on 13 September 2015, when it was announced in the Official Gazette. It is enforced by the President of the Turkish Drug and Medical Device Institution.
Please see this link for full text of the Regulation (only available in Turkish).
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