This article includes:
- SFDA drug registration fees by the drug type.
- Drug Renewal fees.
- Drug Variation.
All fees are provided as official, invoiced by the Saudi Food and Drugs Authority (SFDA). *Does not include the 15% VAT.
DRUG REGISTRATION FEES (SFDA)
The SFDA will invoice the following fees after submission of the eSDR application for drug registration.
*Fees are provided as SAR (Saudi Riyal) and USD (US Dollar).
*To calculate the cost of SFDA registration, you need to add: “SFDA Fees / 1 Product” + “SFDA eSDR Fees”. For example, for one product of Generic Drugs, in USD equivalent, SFDA registration fees should be calculated as: 10,646 + 2,130 = 12,776 USD.
Type | SFDA Fees / 1 (SAR) | SFDA Fees / 1 Product (~USD) | SFDA eSDR Fees (SAR) | SFDA eSDR Fees (~USD) |
New | 95,000 | 25,283 | 20,000 | 5,323 |
Additional Dosage Form | 95,000 | 25,283 | 19,000 | 5,057 |
Additional | 24,000 | 6,387 | 3,600 | 958 |
Additional Pack Type | 5,000 | 1,331 | 2,400 | 639 |
Additional | 1,000 | 266 | 150 | 40 |
40,000 | 10,645 | 8,000 | 2,129 | |
Additional | 40,000 | 10,645 | 8,000 | 2,129 |
Additional Strength | 10,000 | 2,661 | 1,500 | 399 |
Additional | 5,000 | 1,331 | 500 | 133 |
Additional Pack Size | 1,000 | 266 | 150 | 40 |
Health | 20,000 | 5,323 | 4,000 | 1,065 |
Additional Dosage Form | 20,000 | 5,323 | 4,000 | 1,065 |
Additional | 5,000 | 1,331 | 750 | 200 |
Additional Pack Type | 2,000 | 532 | 200 | 53 |
Additional | 1,000 | 266 | 150 | 40 |
Veterinary Drug | 5,000 | 1,331 | 1,000 | 266 |
Additional | 5,000 | 1,331 | 300 | 80 |
Additional Strength | 1,000 | 266 | 150 | 40 |
Additional | 1,000 | 266 | 150 | 40 |
Additional Pack Size | 1,000 | 266 | 150 | 40 |
IV | 15,000 | 3,992 | 3,000 | 798 |
Additional Dosage Form | 15,000 | 3,992 | – | – |
Additional | 1,000 | 266 | 150 | 40 |
Additional Pack Type | 1,000 | 266 | 100 | 27 |
Additional | 1,000 | 266 | 150 | 40 |
Type | SFDA Fees (SAR) | SFDA Fees (~USD) | SFDA eSDR fees | SFDA eSDR fees (~USD) |
New | 30000 | 7,984 | 3000 | 798 |
Generic Drug Renewal | 10000 | 2,661 | 1000 | 266 |
Health | 8000 | 2,129 | 800 | 213 |
Veterinary Drug Renewal | 1000 | 266 | 100 | 27 |
IV | 5000 | 1,331 | 500 | 133 |
DRUG VARIATION FEES (SFDA)
SFDA will invoice the following fees for drug variation applications for every SKU:
3000 SAR (~798 USD) + 1000 SAR (~266 USD)