JAPAN DESIGNATES 40 ORPHAN DRUGS

In Japan, 40 innovative pharmaceutical products currently being developed by 29 manufacturers have been designated as orphan products, the first such designations to be made since the introduction on October 1 of the Pharmaceutical Affairs Law amendments, which includes incentives to encourage the development of orphan drugs. Two medical devices currently in development have also been awarded orphan status.

Initial requests to receive orphan status for their products were received from 87 pharmaceutical companies, the Central Pharmaceutical Affairs Council of the Ministry of Health and Welfare reported in early August.

The Ministerial Ordinance introduced in october stipulated that the estimated patient population for such a product should be under 50,000. According to a report in Pharma Japan, most of the 40 products have a target patient population of under 10,000, although one potential treatment for ulcerative colitis will have a patient population estimated at around 27,000.