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SFDA Reference Countries

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Regulatory Editor

This post will list the reference countries and authorities preferred by the Saudi Food and Drug Authority (SFDA). Nevertheless, we should highlight that having a reference country is not required not that SFDA rely on the approvals issued by other countries. For different reasons, products might receive rejection if they have reference country approval. However, in the tables below, we include the reference authorities that when a product carries one of their licenses will probably have an easier SFDA assessment journey.

Drug

The SFDA will consider approvals from stringent regulatory authorities (SRA) during the drug registration. In fact, there is a specific location in the drug application where applicants can highlight such approvals. It contributes to the reduction of SFDA review timelines.

Here is the list of the reference countries and authorities:

Human ProductsUSFDA, EMA, MHRA (UK), Swissmedic, Health Canada and TGA (Australia).
Veterinary ProductsEuropean 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), they require the same technical file for medical device registration in Saudi Arabia. Therefore, the SFDA reference for medical devices is EU CE registration, but it is not a must-have.

Food

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

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Regulatory Editor

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