Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Orphan drug designation

Saudi Arabia · Saudi Food and Drug Authority · New drugs

Orphan or rare disease designationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

4 requirements

Application fee

What is the Orphan drug designation in Saudi Arabia?

Orphan designation is for medicines for life-threatening or seriously debilitating conditions that affect fewer than 5 in 10,000 people in Saudi Arabia. Incentives can include pre-submission meetings, priority review, scientific and regulatory advice, and pricing support. Before filing for marketing authorization, for a drug in development for a rare condition.

What are the steps of the Orphan drug designation?

1. Notify intent to apply; 2. Pre-submission meeting; 3. Submit the designation application; 4. Validation; 5. Assessment and recommendation; 6. Final decision and public summary; 7. Annual report.

Outcome: Orphan designation with incentives chosen by the agency, kept by annual reporting.

Legal basis: Law of Pharmaceutical and Herbal Establishments and Products and its Implementing Regulations; Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Notify intent to applyThe sponsor tells the agency by email that it intends to apply.
2. Pre-submission meetingA pre-submission meeting with the sponsor.
3. Submit the designation applicationElectronic application with the scientific template. A US FDA or EMA orphan application with a Saudi annex can be used.
4. ValidationThe agency validates the application.
5. Assessment and recommendationThe agency assesses the application.
6. Final decision and public summaryA final decision is adopted and a public summary is published on the agency website.
7. Annual reportThe sponsor sends a yearly report on development to keep the designation.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in Saudi Arabia: Marketing authorization for a new drug or biologic (regular review), Verification pathway (approved by both US FDA and EMA), Abridged pathway (approved by US FDA or EMA), Priority review, Breakthrough Medicine Program, Conditional approval, Rolling submission, New Accelerator Program for Drugs in Rare Diseases (NADR), Research and Investigational Drugs (RAID) designation. See all routes on the Saudi Arabia page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Orphan drug designation

What is the Orphan drug designation in Saudi Arabia?

What are the steps of the Orphan drug designation?

How the pathway works

Timeline with clock stops

Steps

Official time targets

Fees

Requirements

Eligibility

Local presence

After approval