SINGAPORE GOVT ORPHAN DRUG ACT

Under powers conferred by Section 9 of the Medicines Act, Singa-pore's Minister of Health has ruled that an orphan drug is a medicinal product which has been identified by any doctor or dentist as an appropriate remedy, with no effective substitute available for the treatment of any rare disease.

A rare disease is described as a life threatening and severely debilitating illness affecting less than 20,000 people. The lic-ensing authority may permit any person to import or supply the orphan drug without a product license, if that drug is to be used by a doctor or a dentist in the treatment of a patient under his care. Written records of all quantities imported and used will be required. No advertisement for orphan drugs will be permitted in publications circulated to hospitals, and the regulations regarding orphan drug status will cease to apply if the drug's use increases substantially in one year or if a product registration is granted by the authorities.