The Saudi Food and Drug Authority (SFDA) is the regulatory authority in Saudi Arabia responsible for granting national marketing authorisation for all pharmaceutical products and medical devices.

For pharmaceutical products, marketing authorisation can be pursued through four distinct routes:
1. Standard route: applicable to non-innovative drugs
2. Priority review pathway: 40% reduction in review timelines compared to standard pathway
3. Verification pathway: streamlines the process to a swift 30 days if the product has already been registered and marketed by both the FDA and EМА
4. Abridged pathway: offers an expedited route of 60 working days for products that have been registered or marketed by either the FDA or the EMA
5. Breakthrough designation program/pathway: accommodates products not registered in any stringent regulatory authority

The breakthrough designation program was introduced in 2023 and serves as a voluntary program designed to facilitate and accelerate the review of new drugs intended to treat serious or life-threatening conditions where unmet medical needs persist. A key requirement for a breakthrough designation from the SFDA is that the product must not be registered at any regulatory authority at the time of submission of the designation request