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Published by regulatory affairs team in PharmaKnowl, Riyadh office.
This post lists the SFDA timelines for most application types, procedures, and submissions based on the product types. You may use these official timelines to anticipate the time the SFDA needs to review your product during the SFDA registration process.
Table of contents
Drug Review Timelines
The SFDA timelines will significantly decrease if the drug is approved by other recognised stringent regulatory authorities (SRAs). Note that these timelines do not include the time spent responding to SFDA inquiries (clock stop).
Regular Review Timelines
| Drug Type | SFDA Timelines (working Days) |
| Human Generic | 155 |
| Human New Drugs registered in SRA | 280 |
| Human New Drugs not registered in SRA | 405 |
| Human Biologics registered in SRA | 280 |
| Human Biologics not registered in SRA | 405 |
| Radiopharmaceuticals | 280 |
| Veterinary Generics | 165 |
| Veterinary New Drugs registered in SRA | 260 |
| Veterinary New Drugs not registered in SRA | 385 |
| Veterinary Biologics registered in SRA | 260 |
| Veterinary Biologics not registered in SRA | 385 |
| Herbal & health products | 155 |
Priority Review Timelines
| Drug Type | SFDA Timelines (working Days) |
| Human Generic | 93 |
| Human New Drugs registered in SRA | 168 |
| Human New Drugs not registered in SRA | 243 |
| Human Biologics registered in SRA | 168 |
| Human Biologics not registered in SRA | 243 |
| Radiopharmaceuticals | 168 |
| Veterinary New Drugs registered in SRA | 156 |
| Veterinary New Drugs not registered in SRA | 231 |
Verification & Abridged Pathway Timelines
| Procedure Type | SFDA Timelines (working Days) |
| Verification | 30 |
| Abridged | 60 |
Drug Variation Timelines
The SFDA has four types of drug variation submissions, each with a different timeline. When applicants group more than one type, the SFDA applies the longest timeline in the group.
| Variation Type | SFDA Timelines (working Days) |
| IA in | 30 |
| IA | 30 |
| IB | 60 |
| II | 100 |
Drug Renewal
| Procedure | SFDA Timelines (working Days) |
| Drug Registration Renewal | 40 |
Drug Appeal Timelines
Applicants can appeal within 60 calendar days of receiving the SFDA decision, while the second round has only 30 calendar days.
Appeal SFDA Review Timelines
| Appeal Type | SFDA Timelines (Working Days) |
| Registration Rejection (First Appeal) | 60 Days |
| Registration Rejection (Second Appeal) | 30 Days |
| Price Appeal (Reevaluation Request) | 90 Days |
Medical Devices Timelines
MDMA Timelines
Regardless of the risk class, MDMA registration will have the same timelines. The unofficial timeline difference will depend on the completeness of the submitted technical file.
| Procedure | SFDA Timelines (working Days) |
| MDMA Registration | 35 |
| MDMA Update (Minor) | 15 |
| MDMA Update (Major) | 35 |
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