SFDA official: Nader program streamlines access to rare disease treatments
The Nader program offers regulatory incentives to accelerate access to rare disease therapies, supporting researchers and pharmaceutical developers, an SFDA official said.
Key Takeaways
AINawaf Al-Mutairi, Head of Standards Development at the Saudi Food and Drug Authority (SFDA), said the Nader program streamlines access to rare disease treatments through regulatory incentives and facilitation, supporting researchers, innovators, and drug developers.
Speaking to Al Ekhbariya TV, he added that these measures are tailored to the nature of rare diseases while maintaining the quality, safety, and efficacy of the medicines.
He noted that the incentives include specialized scientific and regulatory guidance, flexibility in presenting clinical evidence, and enabling developers and researchers to receive regulatory support and direction throughout the drug development process.
The SFDA launched the Nader program as part of its regulatory framework for rare disease medicines, aiming to boost the development and licensing of pharmaceutical products dedicated to treating rare diseases.
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