SFDA Reference Countries

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

Nevertheless, we should highlight that having a reference country is not required and that SFDA does not rely on the approvals issued by other countries. For different reasons, products might receive SFDA rejection even if they have reference country approval.

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

Drug

The SFDA will consider approvals from stringent regulatory authorities (SRA) during drug registration. Applicants should highlight such approvals in the drug application, which might reduce SFDA review timelines.

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 regards products that have the CE mark. However, it is not necessary to have this certificate to receive approval.

Food

The SFDA food evaluation committees in the food sector often refer to the European Food Safety Authority (EFSA).