【讨论】Japanese Pharmacopoeia and Japanese GMP Regulations available online

zhulikou431

On Japan's Pharmaceuticals and Medical Devices Agency (PMDA) website, you can find in the section "Regulations and Procedures" under the heading "GMP" requirements regarding the inspection of manufacturers of medicinal products and APIs who want to introduce their products into Japan.
Now, a document was supplemented in January 2014 which describes which documents have to be submitted to the Japanese Agency within a pre-approval inspection and/ or a periodical post-approval inspection.
Go to the PMDA webpage to get more information.
There, you can also access the current Japanese Pharmacopoeia Sixteenth Edition in English.
Source: PMDA, Japan

zjlshsh

狗日的日本是世界上最严格的市场进入，而且我们可能要跟他们干一仗，谁还敢做这个市场呀

xiaoshuo101

http://www.dxy.cn/bbs/topic/27677471