5
“The timeline to prepare for a CHMP meeting can be fast and furious.
To succeed, you need to understand the process and have a clear plan
so you can effectively navigate critical milestones.”
Michelle Zucatti |Strategic Communications Lead |3D Communications
Overview of the CHMP Timeline
and Key Meetings
The typical assessment timeline for
an MAA in Europe is based on a review
schedule of 210 active days.³ This
timeline is interrupted by multiple
clock stops so that applicants can
prepare written answers to the CHMP’s
questions and respond to the major
and minor objections. Failure to resolve
major objections will likely result in a
negative CHMP opinion and prevents
authorization in the EU.
Refer to Figure A on the following page
for a standard CHMP review timeline.
CHAPTER 1
5
“The timeline to prepare for a CHMP meeting can be fast and furious.
To succeed, you need to understand the process and have a clear plan
so you can effectively navigate critical milestones.”
Michelle Zucatti |Strategic Communications Lead |3D Communications
Overview of the CHMP Timeline
and Key Meetings
The typical assessment timeline for
an MAA in Europe is based on a review
schedule of 210 active days.³ This
timeline is interrupted by multiple
clock stops so that applicants can
prepare written answers to the CHMP’s
questions and respond to the major
and minor objections. Failure to resolve
major objections will likely result in a
negative CHMP opinion and prevents
authorization in the EU.
Refer to Figure A on the following page
for a standard CHMP review timeline.
CHAPTER 1
5