The Japanese government is beginning to ease restrictions on drug imports – speeding the review and approval of new products, improving the transparency of the process and widening access to medical data.
A streamlined Ministry of Health, Labor and Welfare (MHLW) approval review system will mean that certain advanced pharmaceuticals will be subject to an abbreviated six month approval process.
The change is designed to address the needs of a pharmaceuticals market growing at a breakneck speed, and to hasten innovation in an aging society. Several recent reports project the 2019 pace of growth in Japan as faster than any other mature market in the world for solid dose drugs, and the second fastest for biologicals growth.