SFDA Verification & Abridged Drug Procedures

In February 2017, the SFDA announced two new accelerated drug registration pathways in Saudi Arabia: verification and abridged procedures. The objective of offering expedited review is to ensure 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 designations to the existing New Drug Application (NDA). They provide faster registration than the priority review procedure.

Verification Registration

Drug 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 review timelines of only 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 Registration

The abridged procedure requires only one of the two reference agencies, making it the most used pathway, enabling companies to swiftly apply in Saudi Arabia right after having either EMA or US FDA approval. It has a targeted review 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 for these two procedures, companies must begin preparation as early as possible since there are special requirements, such as localized packaging and other dossier criteria. 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:

• Orphan Drug Designation (ODD) in SFDA
• Breakthrough Medicines Designation in SFDA
• Overview of SFDA Conditional Approval for New Medicines
• Drug Special Access Program (SAP) in Saudi Arabia
• Scientific Office License Requirements by SFDA