SFDA Launches “Nader” Program to Support Access and Development of Rare Disease Medicines
The Saudi Food and Drug Authority (SFDA) has launched the “Nader” program under its regulatory framework for rare disease medicines. The initiative aims to strengthen the development and licensing of pharmaceutical products dedicated to treating rare diseases and to provide regulatory and scientific incentives that help accelerate their availability to patients.
The authority explained that the program targets medicinal products intended to treat or prevent rare diseases with a prevalence of fewer than five cases per 10,000 people in the Kingdom, provided there is no effective treatment available or the product offers a therapeutic advantage over existing options. The product must also be in the development stage or already licensed by another regulatory authority but not yet registered in Saudi Arabia.
SFDA noted that accelerating patients’ access to these medicines is a top priority. To that end, the program offers a package of incentives and facilitations, including scientific and regulatory support, the adoption of flexible and innovative approaches to generating scientific evidence that account for the limited number of patients, streamlined procedures for facility registration, and support for periodic safety reporting requirements.
Finally, the launch of the program comes as part of SFDA’s ongoing efforts to enable patients to access promising treatments and to provide comprehensive healthcare for beneficiaries in the Kingdom, in line with the goals of Saudi Vision 2030 to enhance quality of life.
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