SFDA Verification & Abridged Procedures

In February 2017, the SFDA announced two new accelerated drug registration methods in Saudi Arabia: verification and abridged procedures. The objective of offering expedited review ensures fast patient access to new medicinal products.

The verification and abridged procedures enable pharmaceutical companies to rapidly access the Saudi market only if their drug is approved by one of the acknowledged agencies, such as the EMA and the FDA, but with a few additional conditions. Read: Reference Countries.

These two procedures are additional fast-track options to the existing procedure, the priority review, based on different criteria, broader scope, and longer timelines.

Verification

Registration by verification is the shortest route to SFDA approval, and it is open for newly approved drugs in both the EMA and the US FDA agencies. It is with targeted SFDA timelines of 30 working days and is applicable for:

• New human and veterinary medicinal products that are registered and marketed by both the EMA & FDA.
• New biological veterinary products that are registered and marketed by both the EMA & FDA/USDA.

Abridged

The abridged procedure requires one reference agency only, making it the go-to route for companies well-prepared for submission in the Saudi market. It has a targeted timeline of 60 working days and is applicable for:

• New human and veterinary medicinal products that are registered and marketed by either the EMA or the FDA.
• New biological veterinary products that are registered and marketed by either the EMA or the FDA/USDA.

Requirements

To comply with the SFDA requirements of these two procedures, companies have to begin preparation early. Special and market-specific requirements, such as packaging, translation, printed price, and dossier, are still required. The submitted file must include the following:

• Dossier: in eCTD for human Drugs and vNees or CTD for Veterinary products.
• A copy of the same submitted dossier (M2 to M5) to the reference agency
  • Without drug variations
  • Same Clinical Trials
  • Include Price certificate, SFDA labelling, and Saudi QPPV information in Module 1.
• A complete assessment report from the reference agency.
• Stability studies according to the GCC guidelines for stability testing.
• Other minor supporting documents are available upon the SFDA’s request.

Also Read:

• SFDA Product Registration