How medicines and medical devices get approved in Saudi Arabia

The SFDA must register a medicine before it is marketed in Saudi Arabia. In the regular pathway the agency validates the file, evaluates quality, safety and efficacy, checks the manufacturing site, sets the price, and its Registration Committee decides. Targets are counted in working days and pause while the agency waits for the applicant.

Full application, new active substance · target 280 days · verified October 3, 2026

A faster route for new chemical entities and biologics already approved and marketed by both the US FDA and the EMA. The SFDA relies on both agencies' assessment reports. The official target is 30 working days from the date the agency accepts the pathway.

Reliance route, recognition or verification · target 30 days · relies on EU, US · verified October 3, 2026

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.

Reliance route, abridged review · target 60 days · relies on EU, US · verified October 3, 2026

Priority review cuts the official review target by 40 percent. It is open to new drugs and biologics for serious conditions or unmet needs, to the first biosimilar of an innovator, and to medicines on the national list of unavailable products. The target is 168 working days for new drugs registered with a stringent authority and 243 working days otherwise.

Priority or accelerated review · target 168 days · verified October 3, 2026

A voluntary program for new medicines for serious or life-threatening conditions with unmet needs that are not yet registered anywhere. A scientific committee reviews the request, gives early advice, and the agency targets a 60 working day scientific assessment once the full file is in.

Intensive development support designation · target 60 days · verified October 3, 2026

The SFDA can approve a new medicine on less complete clinical data when it treats a serious or life-threatening disease or is needed in an emergency. The holder must complete studies within set deadlines. Approval lasts two years and can be extended twice, and the medicine is supplied only to the government health sector.

Conditional or accelerated approval · verified October 3, 2026

For highly promising medicines of strategic importance, the agency can review complete sections of the file as they become ready, ahead of a formal conditional approval application. The agency decides on a rolling submission request within 10 working days.

Rolling or phased review · verified October 3, 2026

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.

Orphan or rare disease designation · verified October 3, 2026

A program for medicines for rare diseases with unmet needs, in force since September 2026. Designated products get a dedicated product manager, scientific advice, and access to conditional approval, priority review and rolling submission. The agency also accepts flexible evidence, may waive some quality data, and eases site inspection. The eligibility review target is 20 working days.

Intensive development support designation · verified October 3, 2026

A designation, in force since July 2026, for investigational medicines not yet authorized anywhere whose sponsors commit to run a clinical trial in Saudi Arabia. Designated products get a product manager, scientific advice and pricing support, and later qualify for priority review and rolling submission, and possibly conditional approval.

Intensive development support designation · target 40 days · verified October 3, 2026

A biosimilar is a biological product highly similar to a reference product already approved by the SFDA or a stringent regulatory authority. The applicant shows similarity in a step by step comparison focused on quality. Since July 2026 the agency can waive the comparative efficacy study when the quality data are strong, and it considers approved biosimilars interchangeable.

Biosimilar application · verified October 3, 2026

A generic medicine is registered on the basis of bioequivalence with the original brand. The agency validates the file, evaluates it, sets the price, and its Registration Committee decides. The official target is 155 working days, not counting business validation or time the applicant takes to answer.

Generic application · target 155 days · verified October 3, 2026

There is no separate OTC registration route. An OTC medicine is registered like other medicines, and the Registration Committee sets its legal status (prescription only, controlled, pharmacist only or over the counter) and where it may be sold. A registered medicine can later be switched to OTC through a variation.

Non-prescription application · target 100 days · verified October 3, 2026

No medical device, IVD or medical software may be traded in Saudi Arabia without registration and a marketing authorization from the SFDA. The manufacturer or its Saudi authorized representative files technical documentation through the GHAD system. The agency issues the authorization within 35 business days at most once all requirements are met, and it is valid for up to three years.

Device: registration or licence with the regulator · target 35 days · verified October 3, 2026

For devices with new technology and a clear clinical advantage, the SFDA offers free feedback before filing and then puts the marketing authorization request at the front of the review queue. The review itself is not shortened. Some devices can receive a conditional authorization with post-market limits.

Device: breakthrough or priority program · verified October 3, 2026