Good Vigilance Practice (GVP) - Japan - English translation and explanation of

P

Pythagore

#1
Hello everyone,

I am new in this forum and I would first tell at all, a great thank you for the quality of information that we can find on this site.
I'm looking for an English translation and explanation of the Japanese ordinance No. 135 (Good Vigilance Practice - GVP), I found nothing on this subject and if you could help me, particularly on the difference with the European directive 98/79/EC, it would be great.


Thanks

:thanks:
 
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Stijloor

Staff member
Super Moderator
#2
Hello everyone,

I am new in this forum and I would first tell at all, a great thank you for the quality of information that we can find on this site.
I'm looking for an English translation and explanation of the Japanese ordinance No. 135 (Good Vigilance Practice - GVP), I found nothing on this subject and if you could help me, particularly on the difference with the European directive 98/79/EC, it would be great.


Thanks

:thanks:
Can someone help?

Thanks!

Stijloor.
 
P

Pythagore

#6
Hello,
Thank you for your assistance, I search more specifficaly information about medical device for diagnostic in vitro and japanese ordinance 135, if you have something about that it would be nice.

Many thanks!
 
M

MIREGMGR

#8
As far as I know, the only MHLW ordinances that are provided in "semi-official" translation by MHLW or another official website are 2, 136, 169 and 179. English translations of others must be purchased from a private publisher.

MHLW Ministerial Ordinance No. 135 is available from http://www.yakuji.co.jp/english_publications . Click on “Others”, then on “Pharmaceutical Administration in Japan 2007”.
 
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