Regulatory reliance allows an authority to take account of assessments already completed by trusted reference agencies. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has formalised this through its Verification and Abridged pathways.
What the pathways are
SFDA's guidance describes the pathways as a way to facilitate registration or variations for products already approved by the US FDA, USDA and/or the European Medicines Agency. They apply to marketing authorisation applications for new chemical entities and biologics.
Verification: for human medicinal products approved and marketed by both EMA and FDA, subject to SFDA eligibility, product-sameness and submission requirements.
Abridged: for human medicinal products approved and marketed by EMA or FDA, with a focused review and applicable eligibility requirements.
Important regulatory notes
SFDA states clearly that:
It is not obliged to approve an application simply because a reference agency has approved it.
An application may be moved to the regular pathway if quality, safety or efficacy concerns arise.
Applicants must stay with the chosen reference agency throughout the product lifecycle, including for variations.
Common mistakes
Dossier content that does not match the reference-agency approved version.
Choosing a reference agency without considering future variations.
Incomplete assessment reports or certificates from the reference agency.
How HERMS supports
HERMS assesses pathway eligibility, aligns the Saudi dossier with the reference approval, and builds a lifecycle plan so the chosen reference agency remains workable for future variations.
Evaluating a Saudi launch? Ask HERMS for a pathway eligibility assessment. Contact HERMS →
References
SFDA – Verification and Abridged Pathways, Version 3.0: https://www.sfda.gov.sa/sites/default/files/2026-04/VerificationAbridgedPathways3.pdf
SFDA – Regulatory Notes: https://istitlaa.scbc.gov.sa/en/health/sfda/VerificationAbridgedPathways/Pages/Article_007.aspx