The Drug sector in the Saudi Food & Drug Authority added recently to guidelines list the first draft of the Drug Master File Requirements for Registration of Biosimilars. This draft is available on the web site at :

For all opinions from concerned authorities or professions. Please provide us with your suggestions and feedback about this guideline and practical directions to one of the following addresses.

E-Mail:

Fax Number: (+966)-1-275-7195
Mail address:
Saudi Food and Drug Authority-Drug Sector
P.O. Box 84983 Riyadh 11681
Kingdom of Saudi Arabia