OBJECTIVES

To examine availability of orphan drugs in Saudi Arabia (SA) compared to the United States (US), Japan, Australia and the European Union (EU).

METHODS

Orphan drugs with active designation status and with marketing authorization in the US, Japan, Australia and the EU were accessed and collected using the US FDA, Japan’s National Institute of Biomedical Innovation, Health and Nutrition registries and, Australia’s Therapeutic Goods Administration, and the European Commission databases. Approved orphan indications, orphan routes of administration, pharmaceutical dosage forms used for the orphan indications and years of approval for each drug were collected from the same sources. Saudi Food and Drug Authority (SFDA) drug register was used to check these drugs availability and years of approval.

RESULTS

Orphan drug regulation and policy were vary across countries and that lead to variation in availability and marketing of these products. Out of 668 orphan drugs with orphan designations and active market exclusivity we identified in this study, 32% were approved and registered in SFDA compared to 91% in the US, 59% in Australia, 53% in the EU and 47% in Japan. Of the total products approved in SA, 41% are antineoplastics and immunomodulating agents and 11% are antinfectives.