This post lists the SFDA timelines for most procedures and submissions based on the product types. You may use these official timelines to anticipate the time SFDA needs to review your product during the SFDA registration process.
Drug Review Timelines
The SFDA timelines will significantly reduce if the drug is approved in a Stringent Regulatory Authority SRA (SFDA reference countries). 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 |
Verification & Abridged Pathway Timelines
| Procedure Type | SFDA Timelines (working Days) |
| Verification | 30 |
| Abridged | 60 |
Drug Variation Timelines
| Variation Type | SFDA Timelines (working Days) |
| IA | 30 |
| IB | 60 |
| II | 100 |
Drug Renewal
| Procedure | SFDA Timelines (working Days) |
| Drug Registration Renewal | 30 |
Drug Appeal Timelines
Applicants must appeal within 60 calendar days of receiving the SFDA decision. The second appeal must be submitted within 30 calendar days. After submission of the request, the SFDA appeal review timelines are as follows:
| Appeal Type | SFDA Timelines (Working Days) |
| Registration Rejection (First Appeal) | 60 Days |
| Registration Rejection (Second Appeal) | 30 Days |
| Price Appeal (Reevaluation) | 90 Days |
Medical Devices Timelines
MDMA Timelines
| Procedure | SFDA Timelines (working Days) |
| MDMA Registration (All Risk Classes) | 35 |
| MDMA Update (Minor) | 15 |
| MDMA Update (Major) | 35 |