What is RAID Designation by the SFDA?

RAID  stands for Research and Investigational Drugs (رائــد / Rā’id).

These are drugs or biologics used in clinical investigations that are not yet authorized by the Saudi Food & Drug Authority (SFDA).

The name “Rā’id” reflects “pioneering,” highlighting innovation and development of investigational drugs, particularly when clinical studies are conducted in Saudi Arabia.

What is RAID Designation?

The RAID designation is an official status granted by SFDA to investigational products under development.

It is a voluntary program that:

• Supports R&D and clinical trials in Saudi Arabia.

• Provides regulatory incentives and benefits to sponsors.

• Helps accelerate drug development and review timelines, expediting access to promising new therapies in the Kingdom.

Key Eligibility Criteria for RAID Designation

To qualify, the product must:

1. Be under development and not yet authorized anywhere globally.

2. Show innovative characteristics (e.g., new chemical entity, novel biologic, advanced therapy).

3. Have a committed clinical trial in Saudi Arabia.

Incentives & Benefits of RAID Designation

• Dedicated SFDA contact point (product manager assigned).

• Pre-designation meetings with SFDA experts.

• Scientific guidance & regulatory support during development.

• Pricing support and early consultations.

• Regulatory advantages, e.g.:

  • Priority Review of future Marketing Authorization Application (MAA) → up to 40% faster.

  • Rolling submission of dossier (SFDA can review sections before full MAA).

  • Conditional approval may be possible if supported by interim clinical data.

Application Process (high-level)

1. Pre-designation meeting (optional) – applicant meets SFDA to align.

2. Submission – via eCTD format with RAID application form + supporting data.

3. Validation – SFDA checks completeness (within 15 WD).

4. Evaluation – multidisciplinary SFDA review (within 40 WD).

5. Decision – RAID granted or rejected (within 5 WD after evaluation).

6. If granted → sponsor proceeds with Clinical Trial Application (via Saudi Clinical Trials Registry) and later Drug Registration.

In summary:

• RAID = Research & Investigational Drugs in Saudi Arabia.

• RAID designation = SFDA’s special status that provides incentives and expedited regulatory pathways to encourage local clinical trials, innovation, and faster patient access to novel therapies.