SFDA Launches "Nader" Program for Rare-Disease Drugs

Saudi Arabia has launched a specialized regulatory initiative to speed up access to treatments for rare diseases. Known as the New Accelerator Program for Drugs in Rare Diseases (NADR, or "Nader"), the program was introduced by the Saudi Food and Drug Authority in August 2026 to support the development, evaluation, and authorization of medicines that address rare conditions.

The program operates under a dedicated Regulatory Framework for Rare Diseases Drugs, issued on 5 August 2026 with implementation from 5 September 2026. It covers pharmaceuticals and biologics intended to prevent or treat rare, life-threatening, or seriously debilitating diseases affecting fewer than 5 in every 10,000 people in the Kingdom.

To qualify, a product must address an unmet medical need — meaning no satisfactory treatment currently exists in Saudi Arabia, or the new medicine offers a significant clinical benefit over available options. Eligible products may be at any stage of development, from pre-clinical to Phase III, or already authorized abroad but not yet registered locally for the proposed use.

What the program offers

Products granted "NADR designation" receive a package of regulatory incentives. These include dedicated scientific and regulatory guidance, priority review, and rolling submissions that allow sections of the application to be assessed as they become ready. Where appropriate, conditional approval pathways provide flexibility on clinical evidence, recognizing the small number of patients living with rare diseases.

Applications for the designation are submitted directly to the authority by email using the official form, with all fields mandatory. The process is aimed at drug developers, marketing authorization holders, and sponsors, and is handled through official regulatory channels rather than public e-platforms.

For patients and families in Saudi Arabia affected by rare conditions, the initiative aims to shorten the path to treatments that may otherwise take years to reach the local market.

---

Stay updated with the latest news, events, sports updates, business insights, real estate and lifestyle stories on Saudi Living — the leading online platform for residents, expats, and visitors in Saudi Arabia.

Follow Saudi Living for daily updates:

• Instagram - @saudiliving
• X - @saudiliving
• Facebook - @saudiliving
• YouTube - @saudiliving