Seeking to ease access among patients in Singapore to urgently needed life-saving therapies, the Health Sciences Authority (HSA) in September 2019 announced a faster route to the approval of such critical imports. Under the new regulations, licensed hospitals or clinics, retail pharmacies, and companies acting on behalf of a licensed hospital or clinic may import unregistered therapeutic products if approved by the HSA.
Under the regulation, unregistered therapeutic products can be used in limited situations for which no alternative registered treatment is available. The total amount of imports cannot exceed three months’ dosage per patient based on the manufacturer’s recommended dosage regimen. Because the products have not been evaluated by the HSA for quality, safety, and efficacy, clinicians are entirely responsible for the use of unregistered products by their patients.
Clinicians and others seeking consignment approval to import and supply an unregistered therapeutic product can complete an online form available through the HSA website.