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Saudi Arabian guidelines for generics Posted 01/07/2011

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade and registration in Saudi Arabia.

The SFDA is in charge of licensing the manufacture, import, export, distribution, promotion and advertising of medications, as well as assessing the safety, efficacy and quality of medications, and issuing marketing authorisations.

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.

Overarching guidelines
These guidelines cover all generic products:

Guidelines for pharmaceutical equivalence requirements version 1.1
1 September 2010
www.sfda.gov.sa/NR/rdonlyres/C6CC3730-5B8C-4E82-A261-5EEBC71F3D01/0/PharmaceuticalEquivalence_v11.pdf

Bioequivalence guidelines
These guidelines are specifically related to bioequivalence studies for generic products:

The GCC guidelines for bioequivalence version 2
Issue date: 3 February 2011
Implementation date: 3 May 2011
www.sfda.gov.sa/NR/rdonlyres/8369AD75-FD1B-4F57-9253-65FD062AF666/0/TheGCCGuidelinesforBioequivalence_2011.pdf

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Saudi Arabian guidelines for biosimilars

Source: SFDA

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