According to a Chinese analysis, over 32.000 kinds of drugs from 646 companies are approved in Japan. Following the scandal on Japan’s Chemo-sero Therapeutic Institute (Kaketsuken) last June which led to a limited production stop, a government-ordered self-examination of all companies reportedly led to the result that 70 % of all manufacturing processes did not fully match with the licensed process. Though no safety issues were reported, the MHLW now considers modifications on the registration process.
China Bio news release, June 6, 2016
Japan’s Ministry of Health finds 70 % of drug manufacturers do not fully match with contents of license