Japan’s MHLW Looks to Increased Budget for Device and Drug Oversight

To deal with rising health costs and medical safety concerns, Japan’s Ministry of Health, Labor, and Welfare (MHLW) requested a 4% increase in its budget for fiscal year 2009, which begins in April. The total budget request is for 22.9 trillion yen (about US$213 billion).

The MHLW requested 11.7 billion yen (about US$120 million) for various measures to promote medical device and drug safety as well as speed to market. This represents an 11% increase over 2008. Part of this amount will go to increasing the number of officials reviewing drug and medical device registrations in the Pharmaceuticals and Medical Devices Agency (PMDA). Japan has been under pressure from the device and drug industries internationally to reduce the long review times in its regulatory system.

The new spending also focuses on enhancing post-marketing surveillance at the PMDA. It includes 1.4 billion yen (about US$14 million) dedicated to hiring new staff for the PMDA to do post-marketing surveillance. As many as 100 people may be hired under this program. For the previous fiscal year, only 800 million yen (about US$8 million) was earmarked for a similar program. The new personnel will focus on collecting, reviewing, and analyzing post-marketing safety reports from Japan and abroad.

Other programs in the budget request include promoting the use of generic drugs and encouraging global clinical trials conducted simultaneously in Japan and other countries.