In this post, we list the Saudi Food and Drug Authority’s (SFDA) fees for product registration applications for drugs, medical devices, and cosmetics. We will also cover the entity’s inspection, licenses, and certificate fees for manufacturers, distributors, and warehouses. On the other hand, we list the governmental costs and related charges that take place after the approval, such as renewal, update, and variation fees.
We hope this post helps you budget accurately for your regulatory project in Saudi Arabia.
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 Drug (including Biosimilars) | 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 | 500 | 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 |
| 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 |
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 |
It is SAR15,000 per application paid by the sponsor or the assigned CRO. It is one of the requirements of SFDA clinical trials.
SFDA allows companies to request pre-pricing before submitting the registration application; the fee for this submission is SAR20,000. Regarding pricing appeals, the cost is SAR1,000 per registered SKU.
The following are the inspection fees for drug manufacturer GMP licenses. Note that the inspection fees are applicable on new site registration or renewal every 5 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 |
Every time a drug SFDA certificate is issued, SFDA collects a fee of SAR 1,000.
In addition to the GMP inspection fees, SFDA charges SAR 10,000 for every manufacturer certificate issued.
A fee of SAR 1,000/year is required when issuing the scientific office certificate.
After submission of an MDMA registration application, update, or renewal, the SFDA will issue the related applicable fee as below:
| 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 |
The annual fee for a new or renewed authorised representative certificate is SAR 2600, and the combined fees must be paid in advance if the AR is for multiple years.
Medical device establishment License MDEL fees depend on the types of devices the company deals with. They are SAR 5000, SAR 8000, or more.
There are no SFDA cosmetics registration fees.
Applicants need to pay SAR5000/item during food supplement registration. However, the SFDA classifies some supplements as health products in Saudi Arabia; for such products, you may refer to health product fees on this page.
Registration for animal feeds and fodders is free.
It is SAR1000 for every SFDA Classification application.
