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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

Abridged pathway (approved by US FDA or EMA)

Saudi Arabia · Saudi Food and Drug Authority · New drugs

Reliance route, abridged reviewFaster routeHigh confidenceLast verified October 3, 2026

Review target

60 working days

official guidance

Legal time limit

Not published

Steps

12 requirements

What is the Abridged pathway (approved by US FDA or EMA) in Saudi Arabia?

A faster route for new chemical entities and biologics already approved and marketed by the US FDA or the EMA. The SFDA relies on that agency's assessment reports. The official target is 60 working days from the date the agency accepts the pathway. Since January 2026 the route also covers type II variations. New chemical entities and biologics filed within two years of the reference approval, made in one of the listed countries, and identical to the product the reference agency approved.

How long does the Abridged pathway (approved by US FDA or EMA) take?

The official review target is 60 working days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

What are the steps of the Abridged pathway (approved by US FDA or EMA)?

1. Apply online and pay the fee; 2. Send the designation request and checklist; 3. Eligibility decision (10 days); 4. Business validation (5 days); 5. Evaluation based on the reference agency assessment (40 days); 6. Pricing (10 days); 7. Product licensing (10 days); 8. Moved to another pathway.

Does the Abridged pathway (approved by US FDA or EMA) rely on other regulators?

Yes. It relies on approvals from European Union, United States (shorter review, shorter review).

Outcome: Marketing authorization issued through the SDR system, or transfer to the regular pathway.

Legal basis: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products, Article 11 (reliance on stringent regulatory authorities)

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

About 75 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Apply online and pay the feeThe applicant submits the application in the SDR system, pays the fee and uploads the product file.
2. Send the designation request and checklistThe applicant emails a designation request with the checklist. The agency may ask for a meeting to check eligibility.
3. Eligibility decision10 working daysThe drug sector sends its decision within ten working days. If the product is not eligible, the file moves to another pathway and the fee is not refunded.
4. Business validation5 working daysThe agency checks the file against the requirements.
5. Evaluation based on the reference agency assessment40 working daysThe agency evaluates the file using the reference agency assessment reports. For safety, efficacy or quality concerns, the file can be moved to the regular pathway.
6. Pricing10 working daysPricing under the current pricing rules.
7. Product licensing10 working daysRegistration decision. Approval by the reference agency does not oblige the SFDA to approve.
8. Moved to another pathwayApplications that are not eligible continue in another pathway.

Requirements

What the applicant must provide or meet

Reference approval

Approval by the US FDA or the EMAThe product must be approved and marketed by the US FDA or the EMA (centralized procedure). Only these agencies count as references for human medicines.
Full unredacted assessment reportsComplete clinical and quality assessment reports, question and answer documents and variation reports from the reference agency. Reports taken from the public domain are not accepted.

Eligibility

Filed within two years of the reference approvalThe application must reach the SFDA within two years from the reference agency approval date.
Manufacturing site in a listed countryThe manufacturer must be in one of 20 listed countries, including the USA, UK, Canada, Australia, Japan, Switzerland, Singapore and several EU states.
New chemical entities and biologics onlyThe route covers new chemical entities and biologics. Blood products, advanced therapy medicinal products and veterinary vaccines are excluded. Generics are not accepted.
Also open to type II variations(optional)The abridged route can also be used for type II variations of new chemical entities and biologics, including products first registered through the regular pathway.

Quality and manufacturing

Official time targets

Targets, not actual review times

Decisionofficial guidance. Target for the eligibility decision on the designation request.	10 working days
Review targetofficial guidance. Official target that starts when the drug sector accepts the pathway by email. The eligibility decision and applicant time are not counted. Actual times can differ.	60 working days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

European UnionShorter review, target 60 daysApproved and marketed by the US FDA or the EMA centralized procedure, filed within two years, identical product, site in a listed country. Also open to type II variations.
United StatesShorter review, target 60 daysApproved and marketed by the US FDA or the EMA centralized procedure, filed within two years, identical product, site in a listed country. Also open to type II variations.

Rule changes

Verification and abridged pathways updated (version 3.0)In force, October 20, 2025, effective January 20, 2026

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 (33 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Same product as approved by the reference agencyA signed declaration that formulation, sites, specifications, primary packaging and active ingredient source are identical to the reference approval. A different container type may be proposed for stability needs.
Stability data or a commitmentStability studies under the stability guidelines, or a commitment to run them and to report out of specification results at once.

Other

Dossier format: eCTD matching the reference fileModules 2 to 5 must be the same as filed with the reference agency.
Keep the same reference agency for lifeAll later variations must use the same reference agency chosen at registration.

Inspection

GMP documents when the site is not registered(in some cases)If the manufacturer is not registered with the SFDA, the applicant pays inspection fees and sends GMP certificates, the site master file and recent inspection reports.

Local presence

Local agent for foreign companies(in some cases)Foreign companies without a Saudi commercial investment license must appoint at least one local agent for each product.