RIYADH — The Saudi Food and Drug Authority (SFDA) has launched the New Accelerator Program for Drugs in Rare Diseases (NADR) to support the development of and access to medicines for rare diseases.
Operating within the SFDA’s regulatory framework, NADR is a specialized initiative aimed at streamlining the development, evaluation, and authorization of drugs for rare diseases.
The program also seeks to empower researchers and developers while advancing healthcare innovation.
Through scientific and regulatory incentives, the initiative aims to accelerate patient access to critical treatments while strengthening Saudi Arabia’s position among leading countries supporting research and innovative healthcare solutions.
According to the SFDA, the NADR designation applies to drugs intended to prevent or treat rare diseases, defined as conditions affecting fewer than 5 in 10,000 people in Saudi Arabia.
To qualify, either no satisfactory treatment must currently exist in Saudi Arabia or the product must offer a significant clinical benefit over available therapeutic options.
Products may be under active development at any stage or already authorized by another regulatory authority but not yet registered in Saudi Arabia.
The SFDA emphasized that facilitating timely access to medicines for patients with rare diseases remains a key priority. NADR offers regulatory incentives and support, including scientific and regulatory guidance and flexible approaches to evaluating clinical evidence for small patient populations.
The program also provides flexibility in procedures for manufacturer site registration and inspection, as well as support regarding periodic safety reports.
The launch of NADR forms part of the SFDA’s broader efforts to expand access to rare disease treatments, support comprehensive healthcare for patients in Saudi Arabia, and enhance their overall quality of life.
Source: Saudi Gazette