While Japan is a huge drug market with decent reimbursements, in many ways it is not progressing as quickly as many developed foreign drug markets. In an effort to jump-start more drug activity in Japan, in early July, the Japanese MHLW will set up a new study group to discuss drug losses and drug lags. This group will be formed in response to an earlier MHLW expert team report on Japan’s drug supply situation. In this report, it is noted that about 150 drugs approved in the US and/or EU are still not approved in Japan. In addition, for most of these unapproved drugs in Japan, no local Japanese drug companies are developing drugs for these same problems. This group will discuss how to fix the loss/lag drug problem, revise Japan’s orphan drug system, and other issues.
The MHLW expert team’s report also included a number of other topics. Such topics included – the need for Japanese patient data for Japanese drug approvals, how to have more robust global clinical trials, how to explain the Japanese registration system to foreign biotech companies, and ways to embolden drug companies to also develop children’s products as they develop drugs for adults too. Hopefully, all these efforts will bring Japan’s drug market more closely aligned with the West.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://asia.nikkei.com/Opinion/Policy-confusion-is-keeping-innovative-drugs-out-of-Japan#:~:text=Japan%20is%20currently%20facing%20a,to%20drive%20down%20pharmaceutical%20prices.