2024年5月9日发(作者：魅族魅蓝新机)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH
H
ARMONISED
T
RIPARTITE
G
UIDELINE
S
AFETY
P
HARMACOLOGY
S
TUDIES
F
OR
H
UMAN
P
HARMACEUTICALS
S7A
Current Step 4 version
dated 8 November 2000
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.
S7A
Document History
First
Codification
S7A
New
Codification
History Date
November
2005
Approval by the Steering Committee under Step 2 and
release for public consultation.
2
March
2000
S7A
Current Step 4 version
S7A 8
Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH regulatory
November
2000
bodies.
S7A
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