Conditional approvals on the increase in Japan

Out of 141 drugs containing new active ingredients approved by regulators in Japan in 2000-2005, 53 of them (37.6%) were conditionally approved, according to a recent survey on new drug development conducted by the Japan Pharmaceutical Manufacturers Association.

The Office of Pharmaceutical Industry Research, a JPMA-funded think-tank, investigated whether approval was made with or without conditions, as well as examining the details of the conditions and the relationships between them and the development delay on drug products approved during the five-year period. The study's purpose was to evaluate the current status of post-marketing clinical research that is imposed as a conditional approval.

Among the 53 products, in 23 cases (16.3%) drug firms were requested to conduct a post-marketing survey on safety and efficacy in all patients as a conditional approval while 30 (21.3%) were approved with other conditions.