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

Conditional approval

Saudi Arabia · Saudi Food and Drug Authority · New drugs

Conditional or accelerated approvalFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

9 requirements

Application fee

What is the Conditional approval in Saudi Arabia?

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. New human medicines, including biologics, for seriously debilitating or life-threatening diseases or emergencies, where benefits of early access outweigh the risk of missing data.

What are the steps of the Conditional approval?

1. Pre-submission meeting; 2. Request conditional approval; 3. Agency opinion on the request; 4. Submit the application in eCTD; 5. Assessment; 6. Conditional approval letter; 7. Specific obligations and monthly reports; 8. Extension or full registration.

Outcome: Conditional approval letter valid for two years, with up to two 2 year extensions, then a possible standard authorization valid for 5 years. Valid for 2 years.

Legal basis: Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products, Article 18

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. Pre-submission meetingonly in some casesThe applicant is advised to discuss the planned conditional approval with the agency before applying.
2. Request conditional approvalA formal request with details showing the product meets the scope and requirements.
3. Agency opinion on the requestThe agency evaluates the request and replies by email.
4. Submit the application in eCTDThe applicant files through SDR in eCTD format and notifies the agency by email.
5. AssessmentThe same as the regular review process, although clinical data may be preliminary.
6. Conditional approval letterThe agency decides and issues a conditional approval letter. The Registration Committee handles the conditional approval.
7. Specific obligations and monthly reportsThe holder completes studies within set deadlines and sends monthly summary reports for the first 6 months.

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, Rolling submission, Orphan drug designation, 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Requirements

What the applicant must provide or meet

Eligibility

Serious or life-threatening disease(in some cases)New medicines, including biologics, to treat, prevent or diagnose seriously debilitating or life-threatening diseases.
Emergency use(in some cases)Medicines for emergencies such as a pandemic, for public health threats recognized by WHO or the Saudi Ministry of Health.
Positive benefit-risk balanceThe available data must show a positive benefit-risk balance.
Unmet medical needThe product must fulfil an unmet medical need.

Clinical data

Comprehensive clinical data laterThe applicant must be likely to provide comprehensive clinical data later through specific obligations.

Nonclinical data

Full nonclinical and pharmaceutical dataNonclinical and pharmaceutical data should be comprehensive. Only clinical data may be less complete, with rare case by case exceptions.

Labeling

Black triangle on product informationThe summary of product characteristics and leaflet carry the inverted black triangle and an explanatory statement.

Other

Government supply onlyConditionally approved medicines are supplied only to the government health sector.

After approval

Extension request 6 months before expiry(in some cases)The holder applies for an extension at least 6 months before the approval ends and reports on its obligations.