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Regulatory Editor

Published by regulatory affairs team in PharmaKnowl, Riyadh office.

In this post, we provide the updated official SFDA timelines for application review. It includes different submissions and procedures for all product types. You may use these official timeframes to anticipate the SFDA evaluation time for your product during, for example, an SFDA registration process.

Drug Review Timelines

The SFDA drug registration 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

If your drug was granted a priority review, the timelines are reduced as follows:

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

The verification and Abridged registration for drugs in the SFDA are the most accelerated pathways of drug registration in Saudi Arabia. Here are the expected approval times:

Procedure Type	SFDA Timelines (working Days)
Verification	30
Abridged	60

Drug Designations Timelines

Designation Type	SFDA Timelines (UNOFFICIAL)
Orphan Drug Designation	2 to 4 weeks
Breakthrough Medicine Program	3 to 6 weeks

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

After expiry of the drug certificate, the registration renewal is relatively short, as follows:

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 exact timelines. The unofficial timeline difference will depend on the completeness of the submitted technical file.