
About the Author
Regulatory Editor
Published by regulatory affairs team in PharmaKnowl, Riyadh office.
This post outlines the fees charged by the Saudi Food and Drug Authority (SFDA) for product registration applications for drugs, biologicals, biosimilars, medical devices (MDMA), and other types of products.
We will also cover the inspection, license, and certificate fees for manufacturers, distributors, and warehouses, as well as the governmental costs and related charges applicable after the life cycle management approval, such as renewal, update, and variation fees.
We hope this post helps you accurately budget your regulatory project in Saudi Arabia.
Table of contents
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 or 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
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 |
Variation
SFDA will invoice the following fees for drug variation applications for every SKU:
Type | SFDA Fees (SAR) | SFDA eSDR fee (SAR) |
Drug Variation | 3000 | 1000 |
Clinical Trials
The fee is SAR 15,000 per application, payable by the sponsor or the assigned Contract Research Organisation (CRO). It is one of the requirements of SFDA clinical trials.
Pricing
SFDA allows companies to request pre-pricing before submitting the registration application; the fee for this submission is SAR 20,000. Regarding pricing appeals, the cost is SAR1,000 per registered SKU.
GMP Inspection
The following are the inspection fees for drug manufacturer GMP licenses. Note that the inspection fees apply to new site registration or renewal every five Years.
Country or Region of Manufacturer | SFDA Fee (Human) | SFDA Fee (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 SFDA certificate is issued, SFDA collects a fee of SAR 1,000.
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 |
Class IIb /Class III (CA, PAL) /Annex II List B (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 due for SFDA 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 with a transition period letter | 5000 |
Change notified body due to Brexit (Same NB different number) | 5000 |
Authorised Representative
The fee for an authorised 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 SFDA fees for cosmetics registration.
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 item during the food supplement registration. However, the SFDA classifies some supplements as health products in Saudi Arabia. For such products, please refer to the health product fees on this page.
Feed Application
Registration for animal feeds and fodder is free.
Classification Fee
The fee is SAR 1000 for each SFDA Classification application.
Read More: