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, one must be aware that being in the reference countries or regulatory authorities is not a criterion for obtaining approvals/registrations from the SFDA. However, 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 countries and their respective regulatory authorities for which, when a product carries one of their licenses, the SFDA assessment is likely to be easier.
Drug
The SFDA generally considers the FDA and EMA as reference regulatory authorities for drug registration or applications for expedited pathways and designations. Applicants should highlight such approvals in the drug application to potentially receive a reduction in the official SFDA review timelines, possibly.
Here is the list of the reference countries and regulatory authorities that the SFDA considers during its evaluation process:
| Products | Regulatory Authorities | Reference Countries |
| Human Products | U.S. Food and Drug Administration (FDA) | United States |
| European Medicines Agency (EMA) | European Union (EU) | |
| Medicines and Healthcare products Regulatory Agency (MHRA) | United Kingdom | |
| Swissmedic | Switzerland | |
| Health Canada | Canada | |
| Therapeutic Goods Administration (TGA) | Australia | |
| Pharmaceuticals and Medical Device Agency (PMDA) | Japan | |
| Veterinary Products | European Medicines Agency (EMA) | European Union (EU) |
| Veterinary Medicines Directorate (VMD) | United Kingdom | |
| Health Canada Veterinary Drug Directorate | Canada | |
| Australian Pesticides and Veterinary Medicines Authority (APVMA) | Australia | |
| Food and Drug Administration (FDA) | United States | |
| The French Agency for Veterinary Medicinal Products (ANMV) | France | |
| Health Product Regulatory Authority (HPRA) | Ireland | |
| Federal Office of Consumer Protection & Food Safety (BVL) | Germany | |
| Paul Ehrlich Institute (PEI) | Germany | |
| New Zealand Food Safety | New Zealand | |
| Federal Agency for Medicines and Health Products (FAMHP) | Belgium | |
| Netherlands Veterinary Medicines Institute (SDa) | Netherlands | |
| Spanish Agency of Medicines and Medical Devices (AEMPS) | Spain |
Medical Devices
Since the SFDA primarily adopts the European Medical Device Regulation (MDR) and Medical Device Directive (MDD), it requires the same technical file for medical device registration. Therefore, the SFDA highly values products bearing the CE mark. However, this certificate is not required to receive approval.
Food
The SFDA food evaluation committees often refer to the European Food Safety Authority (EFSA).
Speak to our expert today to learn how Pharmaknowl can help you understand and comply with these regulatory authorities efficiently.
About the Author
Contributed by the PharmaKnowl regulatory affairs team, based in Riyadh. Written and reviewed by our SFDA-experienced consultants.
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