SFDA Fees: Details of all application charges

In this post, we outline and update the official fees charged by the Saudi Food and Drug Authority (SFDA) for product registration applications and other licenses for drugs, biologics, biosimilars, medical devices, and other products and services.

We also cover the required fees for GMP inspections, licenses, and certificates applicable to marketing authorization holders (MAHs), manufacturers, distributors, and warehouses, as well as the governmental costs and related charges incurred during life cycle management, including renewals, updates, and variations.

We hope this post helps you budget your regulatory project in Saudi Arabia accurately.

Drug Fees

Registration

The SFDA invoices the following fees after submission of the eSDR application for drug registration, and it does not include the 15% VAT:

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
New Drugs (including Biologicals, Biosimilars, and Radiopharmaceuticals)	95000	20000
Additional Dosage Form	95000	19000
Additional Strength	24000	3600
Additional Pack Type	5000	2400
Additional Pack Size	1000	150
Generic Drug	40000	8000
Additional Dosage Form	40000	8000
Additional Strength	10000	1500
Additional Pack Type	5000	500
Additional Pack Size	1000	150
Health and Herbal Products	20000	4000
Additional Dosage Form	20000	4000
Additional Strength	5000	750
Additional Pack Type	2000	200
Additional Pack Size	1000	150
Veterinary Drug	5000	1000
Additional Dosage Form	5000	300
Additional Strength	1000	150
Additional Pack Type	1000	150
Additional Pack Size	1000	150
IV Fluids	15000	3000
Additional Dosage Form	15000	–
Additional Strength	1000	150
Additional Pack Type	1000	100
Additional Pack Size	1000	150

Renewal

The following are the charges for drug renewal application:

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
New Drug Renewal	30000	3000
Generic Drug Renewal	10000	1000
Health & Herbal Renewal	8000	800
Veterinary Drug Renewal	1000	100
IV Fluids Renewal	5000	500

Designations

Currently, SFDA does not apply any fees for drug designations, such as Orphan Drug Designation, Breakthrough Medicine Program, conditional approval, priority review, and Verification & Abridged Procedure.

Variation

SFDA will issue an invoice for drug variation applications for every SKU as follows:

Type	SFDA Fees (SAR)	SFDA eSDR fee (SAR)
Drug Variation	3000	1000

Clinical Trials

The fee is SAR 15,000 per clinical trial application (CTAp), payable by the sponsor or the assigned Contract Research Organization (CRO). It is one of the requirements of SFDA clinical trials. Note that it is not applicable when sponsored by a governmental entity.

Pre-Pricing Request

SFDA allows companies to request pre-pricing before submitting the registration application; the fee for this submission is SAR 20,000. For pricing appeals or requests for price increase, the cost will be SAR 1,000 per registered SKU.

GMP Inspection

The following are the GMP inspection fees applicable to every drug manufacturer, including packaging sites, but excluding batch release and testing sites. The same inspection fees apply to new site registration and to the site GMP renewal, which is applicable every five Years.

Country or Region of Manufacturer	SFDA Fee (SAR)(Human)	SFDA Fee (SAR) (Veterinary)
Saudi Arabia	33000	9000
GCC, Yemen, Iraq, Jordan, Syria, Lebanon, Egypt	61000	26000
Libya, Algeria, Tunisia, Morocco	88000	35200
Africa	88000	40000
Europe, Turkey	121000	56800
Southeast Asia (Malaysia, Singapore, India, Pakistan, Iran, Thailand, Philippines)	80000	41600
North and South America	161000	112000
Middle Asia (China, Korea)	103000	54000
Japan, Russia	147000	58800
Australia, New Zealand	184000	73600

Product Certificates

Every time a drug is issued an SFDA certificate, the SFDA collects a SAR 1,000 fee.

Manufacturer Certificates

In addition to the GMP inspection fees, SFDA charges SAR 10,000 for every manufacturer certificate issued.

Scientific Office

A SAR 1,000/year fee is required when issuing the scientific office certificate.

Medical Device Fees

Registration

After submission of an MDMA registration application, update, or renewal, the SFDA will issue the related applicable fee as follows:

Application (Device Class)	SFDA Fees (SAR)
All Class I/ General IVD(Other)/ Exempt IVD(TGA)	15,000
All Class II/ Class IIa /Self-test IVD, Listable IVD	19,000
All other Class III/ Class IV /AIMD /Annexe II List A (IVD)/ Registrable IVD	21,000
All other Class III/ Class IV /AIMD /Annex II List A (IVD)/ Registrable IVD	23,000
MDMA Renewal Only	5,000
Update-Major (adding product, Models, Brand Name Change, manufacturer address change, change in device design (All Jurisdictions)	5,000
Minor update for Label, IFUs, and advertising material	1,100

Update

Below is a list of MDMA update fees according to update type:

Type of Change Request	SFDA Fees (SAR)
Add device/devices	5000
Add model/models	5000
Brand name change	5000
Change in device design	5000
Update label	1100
Update IFU	1100
Update advertising materials	1100
Renew DE	1500
Change jurisdiction	Full fees
Change classification	Full fees
Change the manufacturer’s address/name	Full fees
Minor change to the manufacturer’s name or address	5000
Change notified body	Full fees
Change notified Body	5000
Add model/models	5000

Authorised Representative

The fee for an authorized representative license is SAR 2,600 per year.

MDEL

Medical device establishment license (MDEL) fees depend on the types of devices the company deals with. They are SAR 5000, SAR 8000, or more.

Cosmetics Fees

There are no fees for cosmetics registration with the SFDA.

Food Fees

Food Application

• There are no food registration fees for simple food products.
• Special food registration (with vitamins or special formulas): SAR 5000/product application

Supplements Application

Applicants are required to pay SAR 5,000 per food supplement registration SKU. Note that the authority in Saudi Arabia classifies some types of supplements as health or herbal products. For such products, the applicable fees are outlined under the drug registration, in the health & herbal products subcategory.

Feed Application

Registration for animal feeds and fodder is free of charge.

Classification Fee

The fee is SAR 1,000 per SFDA Classification application.

Read More:

SFDA Review Timelines