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.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
In 2014, the Turkish Medicine and Medical Device Institution's ("Institution") New Year's resolution list included two remarkable items: (i) ensuring people's access to safe human medicinal products, and (ii) battling the grey economy.
The recent Avian Flu outbreak across Europe has been raising cholesterol across the industry since December of last year when the government issued a prevention order requiring farmers to keep their birds inside to help prevent the spread of the disease.
New legislation regulating e-cigarettes in the Czech Republic entered into force on 1 March 2017, introducing specific safety and quality requirements on e-cigarettes in the country for the first time.
The amendment aims at alleviating the existing regime for pricing of pharmaceuticals for home treatment of chronic, genetic and/or rare diseases and paid by the National Health Insurance Fund
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).