Search results with tag "Pharmaceuticals for human"
M 4 S Common Technical Document for the Registration of ...
www.ema.europa.eupharmaceuticals for human use nonclinical overview and nonclinical summaries of module 2 organisation of module 4 (cpmp/ich/2887/99 - safety) transmission to cpmp july 2000 release for consultation july 2000 deadline for comments september 2000 ...
TECHNICAL AND REGULATORY CONSIDERATIONS FOR …
database.ich.orgTECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE . ICH HARMONISED GUIDELINE . TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT . Q12 . Final version . Adopted on 20 November 2019 . This Guideline has been developed by the appropriate ICH Expert …
ICH HARMONISED GUIDELINE
database.ich.orgREQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) ICH HARMONISED GUIDELINE INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) Current Step 4 version dated 9 November 2016 . E6(R1) Document History First Codification History Date New Codification