In an effort to reduce the drug lag in Japan, in mid-September, the MHLW said, in general, Phase 1 drug clinical studies are not required before late-stage global studies. This notification will amend the prior notification in 2007 and render invalid a 2014 notification on the same topic. This future notification will emphasize that Phase 1 studies are not needed especially for drugs where there is a high demand like orphan and pediatric drugs.
Despite the above change, the MHLW still would like Phase 1 studies to be done in Japan for global studies in certain situations including when there is enough time to do them, the drug will be used by a huge number of Japanese patients, and where there is a likelihood of a large number of adverse events. Even when the new Phase 1 notification goes into effect, the MHLW recommends that companies still explore ethnic differences before regulatory submissions. In addition, this policy revision will not apply to Japanese-made drugs that originate in Japan.
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://www.mhlw.go.jp/english/index.html