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Q11_Step_2

Q11_Step_2

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Published by Raju Nalla

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Published by: Raju Nalla on Nov 01, 2011
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09/05/2014

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICALREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
D
RAFT
C
ONSENSUS
G
UIDELINE
 
D
EVELOPMENT AND
M
 ANUFACTURE OF
D
RUG
S
UBSTANCES
(C
HEMICAL
E
NTITIES AND
B
IOTECHNOLOGICAL
 /B
IOLOGICAL
E
NTITIES
)Q11
Current
Step 2 
versiondated 19 May 2011
 At Step 2 of the ICH Process, a consensus draft text or Guideline, agreed by theappropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the EuropeanUnion, Japan and the USA) for internal and external consultation, according tonational or regional procedures.
 
 
Q11Document HistoryCurrent
Step 2 
version
Code History DateQ11 Approval by the Steering Committee under
Step 2 
 and release for public consultation.19 May2011
 
 
D
EVELOPMENT AND
M
 ANUFACTURE OF
D
RUG
S
UBSTANCES
(C
HEMICAL
E
NTITIES AND
B
IOTECHNOLOGICAL
 /B
IOLOGICAL
E
NTITIES
)
Draft ICH Consensus Guideline
Released for Consultation on 19 May 2011, at
Step 2 
of the ICH Process
TABLE
 
OF
 
CONTENTS
i

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