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Pharma Knowledge Base

SFDA Special Access Program (SAP) – Saudi Arabia

SFDA SAP Request FormSFDA Drug Registration Rules21 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

SFDA allows import of unregistered drugs for individual patients with serious unmet medical needs in Saudi Arabia, subject to physician request and SFDA approval.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

SFDA Circular 2019

Countries Using This Pathway (1)

SA
Saudi Arabia
SA
SFDA Special Access Program (SAP) – Saudi Arabia
Approval FormSFDA SAP Request Form
Timeline21 days
Legal StatusSFDA Drug Registration Rules
Source Ref.SFDA Circular 2019
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified