Saudi Food and Drug Authority launches 'Nader' program to speed up rare disease drug approvals

The Saudi Food and Drug Authority has launched the 'Nader' program as part of its regulatory framework for rare disease medicines, aiming to enhance the development and licensing of pharmaceutical products for these conditions and expedite patient access in the Kingdom.

The program targets pharmaceutical products that treat or prevent rare diseases, defined as those affecting fewer than five in 10,000 people in Saudi Arabia, provided there is no effective existing treatment or the product offers significant therapeutic benefits over current options. Eligible products must also be in development or licensed by an external regulatory authority but not yet registered in the Kingdom.

The Authority stated that the program offers a range of incentives and facilitations, including scientific and regulatory support, flexible approaches to compiling scientific evidence considering the limited patient populations, as well as streamlined procedures for factory registration and support for periodic safety report requirements.

The Authority also emphasized that accelerating access to these medicines for rare disease patients is a top priority. The program is part of ongoing efforts to enable patients to benefit from promising treatments and to provide comprehensive healthcare in line with the goals of Saudi Vision 2030.