SFDA Verification & Abridged Procedure for EMA/FDA approved applications

In Feb 2017, SFDA announced the verification and abridged evaluation as two new accelerated drug registration procedures with the objective to ensure fast access to new medicinal products.

Pharmaceutical companies can benefit from fast access to the Saudi market if their drug is already approved by one of the acknowledged reference agencies.

Worth mentioning that these two procedures are different from the SFDA priority review that is based on different criteria, wider scope, and with longer timelines.

SFDA Verification Evaluation

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

  • New human and veterinary medicinal product that is registered and marketed by both EMA & FDA.
  • New biological veterinary product that is registered and marketed by both EMA & FDA/USDA.

SFDA Abridged Evaluation

This procedure requires one reference agency only which makes it the go-to route for companies that are well prepared for submission in the Saudi market. It is with targeted timelines of 60 working days, and applicable for:

  • New human and veterinary medicinal product that is registered and marketed by either EMA or FDA.
  • New biological veterinary product that is registered and marketed by either EMA or FDA/USDA.

Requirements for SFDA verification & abridged registration

To comply with the requirements of these two procedures, companies have to initiate their preparation at early stages especially with regard to those with longer timelines such as stability studies. Special and market-specific requirements are still to be required, such as packaging, translation, printed price, and dossier. The submitted file must include:

  • 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..
  • A complete assessment report from the reference agency.
  • Stability studies according to GCC guidelines for stability testing.
  • Other minor supporting documents upon SFDA request.