Japan to Speed Approval Process of Drugs Approved Elsewhere

Japan’s Ministry of Health, Labor, and Welfare (MHLW) is continuously striving to address drug lag and decrease domestic drug approval time. Its newest scheme is to enact several policies to quicken the approval process for drugs already approved in other countries.

On average, drugs take four years to get approved in Japan when they only take about 1.5 years in the UK and US. Therefore, Japanese patients must wait years for drugs that are already available in the EU or US. Other delays arise with local Japanese clinical trial requirements and high costs for research and development. Therefore, many Japanese pharmaceutical companies have opted to conduct R&D in China and India. This has caused concern that the Japan drug market could become stagnant.

The MHLW plans to decrease the approval process time to 1.5 years by 2011 through various staff expansions. They plan to increase staff investigating new drugs to more than 190 investigators. The MHLW will also increase the number of times it meets with drug makers by 50% to discuss applications and requirements.