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
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).
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.
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