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Turkish guidelines for biosimilars Posted 27/04/2012

Last update:  27 April 2012 

The regulatory body for approval of medicines in Turkey is the General Directorate of Pharmaceuticals and Pharmacy (GDPP). The agency is responsible, under the authority of the Ministry of Health of the Turkish Government, for the registration, marketing approval/authorisation, pricing of pharmaceuticals, legal classification, control of advertisement for pharmaceutical products as well as inspection of pharmaceutical manufacturers, wholesalers and retail pharmacies. The agency is assisted in its tasks by a number of expert committees.

The legal basis for the pharmaceutical sector in Turkey is the Act on Medicinal Products for Human Use from 1928, which has been updated via various amendments.

Ministry of Health regulations stipulate that product registration can only be granted to a firm registered in Turkey. Thus, any pharmaceutical product imported into Turkey should be registered in the name of a Turkish agent or a Turkish commercial entity. Prior registration by a competent authority such as EMA or FDA facilitates Turkish registration but is not a prerequisite [1].

GDPP has the following guideline regarding biosimilars:

Overarching Guideline
This guideline covers all biosimilar products:

Biosimilar medicinal products guide
Effective date: August 2008
www.iegm.gov.tr/Folders/TheLaws/Biobenzer_Kilavuzu,07.08.2008,Eng._4621062.pdf

Turkey does not have any product-specific guidelines. The overarching guideline above refers to EMA guidelines for information regarding specific product types, e.g. G-CSF, epoetin, etc.

Related article

EU guidelines for biosimilars

Source: GDPP, WHO

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