急急！！关于欧盟药品管理法！

pippo_13

The Rules Governing Medicinal Products in the European Union
, c% l/ s8 s, p( X. R有没有人关于这10点的中文资料啊~~
/ y6 `8 w! H/ v2 K6 c我在做老师给的课题...可是以前都没接触过...
7 w) F9 k, [/ C  i都不了解...  r' H1 E+ |' G/ a! i: e( L0 F' q
求救求救~~

ygfyzy

The Rules Governing Medicinal Products in the European Union包括：+ @8 k7 V% \$ d% A" O  m1 t
Volume 1 – EU pharmaceutical legislation for medicinal products for human use
- U. q9 a$ n1 q) aVolume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use + x( G/ k" [1 y: {+ M% r" F
Volume 3 - Scientific guidelines for medicinal products for human use
( A% T- _. z& I+ rVolume 4 – Guidelines for good manufacturing practices for medicinal products for human and veterinary use % T/ W* n0 @! t7 \% u
Volume 5 – EU pharmaceutical legislation for medicinal products for veterinary use Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use ; M) U( t$ _5 |) @
Volume 7 - Scientific guidelines for medicinal products for veterinary use
- R4 w: }1 S% V9 o! q! L1 IVolume 8 - Maximum residue limits + m+ w1 F0 |6 e* m7 z8 X) k
Volume 9 – Guidelines for pharmacovigilance for medicinal products for human and veterinary use ! P! l$ k1 {; O: i% k; M3 \: B& J' m
Volume 10 – Guidelines for clinical trial
1 ]! o# u  t7 j2 S$ l: T要全部的中文网上好象还没有（只有部分）。' ?1 n+ }( M! J) E& {
全部的原文见：http://ec.europa.eu/enterprise/p ... lex/eudralex_en.htm) R- F& J& {7 K; W
呵呵，可以自己动手啊！