关于ASMF的保密部分

宝丽金

The RP may contain the remaining information, such as detailed information on the individual steps of
the manufacturing method (reaction conditions, temperature, validation and evaluation data of critical
steps) and the quality control during the manufacture of the active substance. The National Competent
Authorities/EMA may not accept that particular information has not been disclosed to the Applicant/MA
holder. In such cases, the National Competent Authorities/EMA may ask for an amendment to the AP.

这是描述，然后给的附件里面打些叉叉和a,b,c,d这什么意思啊，没看明白具体哪些可以不用放到AP部分啊？！

kslam

a) Flow chart and short description is regarded as sufficient, if detailed information is presented in the
Restricted Part. However, full validation data on the sterilisation process may be requested in the
Applicant’s Part (in cases where there is no further sterilisation of the final product).
b) Detailed information.
c) As far as the information is also relevant for the Applicant/MA holder.
d) As far as the information is related to the detailed description of the manufacturing process and as
far as this information is not relevant for the Applicant/MA holder.
e) In so far as the information is related to the detailed description of the manufacturing process and
in so far as the ASMF holder sufficiently justifies that there is no need to control these impurities in
the final active substance.
f) As far as the information is related to the detailed description of the manufacturing process, control
of materials and process validation.

宝丽金

kslam 发表于 2014-6-14 18:36
a) Flow chart and short description is regarded as sufficient, if detailed information is presented  ...

不好意思，看的时候没注意到。thanks!

一沙一叶

kslam 发表于 2014-6-14 18:36
a) Flow chart and short description is regarded as sufficient, if detailed information is presented  ...

送朵鲜花赞你一下。

yanzhengren

谢谢分享。

岚中漫步

送朵鲜花赞你一下。

18796755811

这个图片在哪能找到