In 2026, the Saudi Food and Drug Authority (SFDA) introduced the Research and Investigational Drugs (RAID) designation to support drug research and development. It is one of several designations and accelerated pathways the authority offers. The RAID designation is intended to help bring innovative drugs and biologics to patients more quickly. This article will help pharmaceutical and biotech companies, including researchers and developers, understand RAID eligibility criteria, incentives, and procedures.
This article will help pharmaceutical and biotech companies, including researchers and developers, understand RAID eligibility criteria, incentives, and procedures.
Table of content
- Who can apply for RAID designation?
- When can they apply?
- Criteria for RAID designation
- RAID Designation Incentives and Benefits
- What’s next after RAID designation?
- How can I proceed?
Who can apply for RAID designation?
Applicants such as Marketing Authorization Holders (MAHs) or research centers with rights to an investigational molecule or therapy that plan to submit a Marketing Authorization Application (MAA) to the SFDA in the future can apply for RAID designation.
When can they apply?
Products under development may be submitted at any clinical phase, including Phases I, II, or III.
Criteria for RAID designation
Since RAID designation is voluntary, all of the following criteria must be met to be eligible.
- The product is under development.
- The product is not approved by any authority worldwide, including the country of origin (COO).
- It should address unmet medical needs.
- Provide scientific and clinical evidence to prove that the proposed development is better than the current one at the time of submission.
- A clinical trial for the investigational product must be conducted in Saudi Arabia.
Contact us at PharmaKnowl for more information about the trial type, obligations, and required preparations.
RAID Designation Incentives and Benefits
Receiving the RAID designation entitles the product to various incentives and benefits to support its development and review, such as:
- SFDA dedicated product manager
- Pre-designation meeting with a group of experts from SFDA
- Scientific guidance regarding developmental strategies aligned with SFDA requirements
- Pricing guidance, early consultations, and parallel pricing and registration reviews
- Priority Review of the Marketing Authorization Application (MAA)
- Rolling submission of MAA
- Conditional approval if supported by clinical data
What’s next after RAID designation?
Since RAID is granted only for products that undergo clinical trials, the applicant is expected to submit an MAA to the SFDA after completing the trials. If eligible, they can also apply for the Breakthrough Medicine Program after Phase II.
How can I proceed?
If you are interested in learning more and having an online discussion about RAID designation, our experts at PharmaKnowl can assist and guide you in a complimentary online meeting.
We have secured a substantial portion of the SFDA’s total designations granted in 2025 and 2026. Our team will evaluate your product’s status and create a plan to help you gain quicker access in Saudi Arabia.
Contact us now to speak with an expert.
About the Author
Contributed by the PharmaKnowl regulatory affairs team, based in Riyadh. Written and reviewed by our SFDA-experienced consultants.
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