In Feb 2017, SFDA announced two new accelerated ways of drug registration in Saudi Arabia, named the verification and the abridged procedures. The objective of offering the expedited review is to ensure fast patient access to new medicinal products.
The verification and the abridged procedures enable pharmaceutical companies to fastly access the Saudi market only if their drug is approved by one of the acknowledged reference agencies, EMA or FDA, but with few additional conditions.
These two procedures are additional fast-track options to the already existing procedure, the priority review, which is based on different criteria, wider scope, and longer timelines.
Verification
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 is 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.
Abridged
The abridged 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 is 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
To comply with the SFDA 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
- 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 GCC guidelines for stability testing.
- Other minor supporting documents upon SFDA request.
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