Latest developments in Japan pharma sector

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reported its self evaluation to the Ministry of Health, Labor and Welfare (MHLW) on August 6. The agency gave itself the highest rating on two of 18 evaluation items on performance in fiscal year 2012.

The two items were (1) action speed and organizational improvement in pharmaceutical administration, and (2) cost control. The PMDA highlighted improvement in new drug approval as evidence for the high scores.

Median time spent on approval of new drugs with priority status was 6.1 months compared to 6.5 months in 2011 and requirement of nine months. Median time to approve non-priority new drugs was 10.3 months compared to 11.5 months in the previous year and the 12 month goal. The Health Ministry was scheduled to gather opinion from members of the Evaluation Committee for Incorporated Administrative Agency and finalize its evaluation of PMDA in late August.