OrphanDrug
OrphanDrug
Pharma Knowledge Base
SA

Saudi Arabia

SA

Middle East

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways

Regulatory Overview

Saudi Arabia is regulated by the SFDA. The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

SFDA

Regulatory Pathways (1)

SFDA Special Access Program (SAP) – Saudi Arabia 21 days

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

Application Form: SFDA SAP Request Form
Legal Basis: SFDA Drug Registration Rules
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: SFDA Circular 2019
SA
Saudi Arabia
ISO CodeSA
RegionMiddle East
Regulatory AuthoritySFDA
Pathways1 documented
Drugs Available0 documented