t******o
发帖数: 5314 | 1 活性成分多了机理说不清情有可原，活性成分的分子结构是不是也算是眼开眼闭了？ |
N***n
发帖数: 660 | 2 你先写个CMC出来看看
【在 t******o 的大作中提到】
: 活性成分多了机理说不清情有可原，活性成分的分子结构是不是也算是眼开眼闭了？
|
j******w
发帖数: 97 | 3 I recently read a few articles about botanical products, including
traditional Chinese medicine. A few points articulated by the articles:
1) No Chinese medicines (probably no botanical products) have been approved
by FDA as drugs. They are mainly sold as dietary supplements.
2) There are quite some efforts in pushing botanical products to market
approval. Over 400 clinical studies, in various stages, are registered in
clinicaltrials.org. However, only a relative small percent (25%?) are
placebo |
M*****e
发帖数: 1827 | 4 great summary! Thanks a lot
Any information about botanical products in Japan? And Japanese
regulatory experience with botanicals?
approved
【在 j******w 的大作中提到】
: I recently read a few articles about botanical products, including
: traditional Chinese medicine. A few points articulated by the articles:
: 1) No Chinese medicines (probably no botanical products) have been approved
: by FDA as drugs. They are mainly sold as dietary supplements.
: 2) There are quite some efforts in pushing botanical products to market
: approval. Over 400 clinical studies, in various stages, are registered in
: clinicaltrials.org. However, only a relative small percent (25%?) are
: placebo
|
ot
发帖数: 4549 | 5 Japan use the same CTD system as US and EU. You still have to submit CMC for
new drugs. Currently ICH does not have plan to issue Herbal CTD guidelines.
【在 M*****e 的大作中提到】
: great summary! Thanks a lot
: Any information about botanical products in Japan? And Japanese
: regulatory experience with botanicals?
:
: approved
|
