Saudi Arabian Biosimilars Guideline

August 25, 2011 1:39 PM

The Saudi Food and Drug Authority (SFDA) is responsible for controlling all drug registration activities in Saudi Arabia.

The main purpose of the SFDA establishment is to regulate, oversee and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured.

The SFDA also carries out inspections and surveillance of manufacturers, importers, wholesalers and dispensers of medicines; controls promotion and advertising of medicines; and provides independent information on medicines to professionals and the public.

In Saudi Arabia, final guidelines covering biosimilars were published by the SFDA in December 2010.

The guideline is in English and can be accessed from here.

The guideline contains separate chapters on specific biosimilar products including insulin, interferons, erythropoietins, granulocyte colony stimulating factors and growth hormones but not monoclonal antibodies yet. Also the guideline has a separate chapter about the Drug Master File (DMF) requirements for the registration of biosimilars.

A newer version (version 1.1.) of the DMF requirements can be accessed from here.


Source: Saudi FDA


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