ICH HARMONISED TRIPARTITE GUIDELINE: GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1)

文件名称:ICH HARMONISED TRIPARTITE GUIDELINE: GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1)
文件路径:http://acmctr.org/uploads/file/81c3b3a8-f7d0-4a64-bcaf-2cfed49cdcf7.pdf

 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE
ICH H ARMONISED  T RIPARTITE  G UIDELINE
G UIDELINE FOR  G OOD  C LINICAL  P RACTICE
E6(R1)
Current Step 4 version
dated 10 June 1996
(including the Post Step 4 corrections)
This Guideline has been developed by the appropriate ICH Expert Working Group and
has been subject to consultation by the regulatory parties, in accordance with the ICH
Process. At Step 4 of the Process the final draft is recommended for adoption to the
regulatory bodies of the European Union, Japan and USA.

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