This post will list the reference countries and stringent authorities preferred by the Saudi Food and Drug Authority (SFDA) during the product registration and review process.

Nevertheless, we should note that a reference country is not required, and that SFDA does not completely rely on approvals issued by other countries. For various reasons, products might be rejected by the SFDA even if they have approval from the reference country.

In the tables below, we include the reference authorities for which, when a product carries one of their licenses, it will likely have an easier SFDA assessment journey.

Drug

The SFDA will consider approvals from stringent regulatory authorities (SRA) during drug registration or applications for expedited pathways and designations. Applicants should highlight such approvals in the drug application to receive a reduction in the official SFDA review timelines, possibly.

Here is the list of the reference countries and authorities:

Human Products

USFDA, EMA, MHRA (UK), Swissmedic, Health Canada and TGA (Australia).

Veterinary Products

European Medicine Agency, Veterinary Medicines Directorate (UK), Health Canada Drug Product Database, Australian Pesticides and Veterinary Medicines Authority, Food and Drug Administration (USA), The French Agency for Veterinary Medicinal Products, Health Product Regulatory Authority (Ireland), Federal Office of Consumer protection and Food Safety & Paul Ehrlich Institute (Germany), New Zealand Food Safety, Federal Agency for Medicines and Health Products (Belgium), The Netherlands Veterinary Medicines Institute and Spanish Agency of Medicines and Medical Devices (Spain).

Medical Devices

Since the SFDA mainly adopts the European Medical Device Regulations (MDR) and Medical Device Directives (MDD), it requires the same technical file for medical device registration. Therefore, the SFDA highly values products bearing the CE mark. However, it is not necessary to have this certificate to receive approval.