Turkish Biosimilars Guideline

August 18, 2011 10:08 AM

Under the authority of the Ministry of Health of the Turkish Government, General Directorate of Pharmaceuticals and Pharmacy (GDPP) is the regulatory body for pharmaceutical products in Turkey.

GDPP is responsible for regulating therapeutic goods including pharmaceuticals, medical devices, blood and blood products, clinical studies etc.

Turkey is a developing country and is not a member of the EU yet. But in the recent years, Turkey adopted EU guidelines in the local law and Biosimilar Guideline is one of them.

The first publication of the Biosimilars Guideline was on August 2008 and one year after, some minor changes were made which is highly critical by some means.

Biosimilar Medicinal Products Guide of Turkey does not have any product-specific guidelines and for the time being, only two biosimilar products are approved in Turkey.

Biosimilar Medicinal Products Guide

Actually the link shows the first version of the guideline and GDPP (IEGM in Turkish) does not have any latest English versions on their website.


Source: IEGM



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