Japan's health ministry panel holds hearing on drug approval delay

The study committee on swiftly providing new safe and effective drugs within Japan's Ministry of Health, Labor and Welfare, at its second meeting on December 7, received depositions from the Japan Pediatric Society (JPS), a cancer patient association, a drug-induced sufferers association, and Japanese representatives for, respectively, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations.

Hidefumi Nakamura of the JPS suggested that there is a need to establish a law to give pharmaceutical manufacturers incentives such as a reduction and exemption of review fees, priority review and additional premiums on National Health Insurance drug prices, to promote the development of pediatric drugs and to obligate clinical trials for drugs which need pediatric use as well as improving infrastructures for clinical trials at pediatric hospitals.

Faster approval of new drugs urged