SFDA timelines for drug approval, variation, and renewal

In September 2020, the SFDA announced its new approval timelines with a great reduction in the targeted performance time for drug registration evaluation. However, companies need to be careful of the maximum allowed time to respond back to inquiries that had been reduced in addition to the maximum inquiry waves allowed. In this article, we will list all types of SFDA official approval timeline that is important in developing drug registration strategy.

Drug Registration Timelines

Normal Review Timelines

  • Human Drugs
    • Generic Drug: 155 working day
    • New Drug (Registered in SRA): 280 working day
    • New Drug (Not registered in SRA): 405 working day
    • Human Biologics (Registered in SRA): 280 working day
    • Human Biologics (Not registered in SRA): 405 working day
    • Radiopharmaceuticals: 280 working day
    • Herbal and Health Products: 155 working day
  • Veterinary Drugs
    • Generic Veterinary Drug: 165 working day
    • Veterinary New Drug (Registered in SRA): 260 working day
    • Veterinary New Drug (Not registered in SRA): 385 working day
    • Veterinary Biologics (Registered in SRA): 260 working day
    • Veterinary Biologics (Not registered in SRA): 385 working day

Priority Review Timelines

This is the fast track review offered by SFDA for specific types of pharmaceutical products. You can read all about it in our article: Eligibility for SFDA Priority Review registration: 40% faster. Note that it is not applicable for human herbal and health products nor to veterinary drugs. Here are the reduced timelines as follows:

  • Human Generic Drug: 93 working day
  • Human New Drug (Registered in SRA): 168 working day
  • Human New Drug (Not registered in SRA): 243 working day
  • Human Biologics (Registered in SRA): 168 working day
  • Human Biologics (Not registered in SRA): 243 working day
  • Radiopharmaceuticals: 280 working day

Verification and Abridged registration timelines

This is the shortest way possible for pharmaceutical products registration at the SFDA. It is applicable for drugs that were approved recently in the US FDA or EMA (must be submitted to SFDA within 2 years of their reference agency approval). You can read all about it in our article: SFDA Verification & Abridged Procedure for EMA/FDA approved applications. The official timelines are as follows:

  • Verification Registration: 30 working days
  • Abridged registration: 60 working days.

Variation Approval Timelines

Type IA Variation

  • It is a minor variation falls under “Do and Tell” procedure.
  • Implementation can take place prior to submission to SFDA.
  • Does not require formal approval by SFDA
  • MAH must notify SFDA within 60 days of implementation.
  • Approval timelines: 30 working days.

Type IB Variation

  • It is a minor variation that falls under the “Tell, Wait, and Do” procedure.
  • Must be submitted to SFDA prior to implementation.
  • Does not require formal approval by SFDA
  • MAH can implement it after 60 days post submission day.
  • Approval timelines: 60 working days.

Type II Variation

  • It is a major variation with a possible significant impact on quality, safety, or efficacy.
  • Require prior approval before implementation
  • Approval timelines: 100 working days.

Combined Variations Timelines

  • The longest timelines will be applicable.
  • For example, type IB and II were submitted together, the approval timeline: 100 working days.

Renewal Approval Timelines

  • Approval timelines: 40 working days.

Response to Inquiry Timelines

  • Response to evaluation inquiry (Quality, Safety, Efficacy, price): 60 working days.

Appeal Timelines

The following timeline is applicable for appealing on SFDA decision on registration, variation, and renewal. Note that it is not working days based.

  • Appeal Timelines: 60 calendar days from date of SFDA letter.

Why can’t we consider these timelines as a solid reference?

  • Clock Stop
    This means the day’s counter will stop once an inquiry is sent to the company and resumes whenever the response is submitted back to the authority. Consequently, the time taken for the evaluation will extend for an unknown number of days.
  • Inquiry response deadline
    Some companies need to consume most of the time window given by SFDA to respond to an inquiry. This could easily add several months to the targeted registration timeline. Given that each inquiry might take up to 3 months to respond to.
  • Validation Days
    SFDA performs technical and business validation before the beginning of the actual evaluation. Validation timelines take from 2 to 30 working days.
  • Working Days
    In addition to weekends, public Saudi holidays are not counted in the performance timelines, such as Eid breaks.

What are the reference agencies “Stringent Regulatory Authority” (SRA) that affect the registration timelines?

For human products:

USFDA, EMA, MHRA (UK), Swissmedic, Health Canada and TGA (Australia).

For veterinary products:

European Medicine Agency, Veterinary Medicines Directorate (UK), Health Canada Drug Product Database, Australian Pesticides and Veterinary Medicines Authority, Food and Drug Administration (USA), The French Agency for Veterinary Medicinal Products, Health Product Regulatory Authority (Ireland), Federal Office of Consumer Protection and Food Safety & Paul Ehrlich Institute (Germany), New Zealand Food Safety, Federal Agency for Medicines and Health Products (Belgium), The Netherlands Veterinary Medicines Institute and Spanish Agency of Medicines and Medical Devices (Spain).