Company and agency viewpoints: Top 10 attributes that enable transparency,
timeliness, predictability and quality in the registration process
Company Top 10
Company
Ability to have dialogue with assessor
for clarification of issues raised in
deficiency letter
100
Pre-submission dialogue
100
Agency
Agency Top 10
Company
Agency
55
Decision frameworks (eg, benefit-risk
framework)
67
100
36
Internal training (ie, by experienced internal
staff)
58
100
92
91
Detail of approval process: Detailed
description of each stage of the
approval process including target times
92
91
Detail of approval process: Detailed
description of each stage of the approval
process including target times
Adherence to target timelines during
review
92
82
Publication of established guidelines used by
reviewers
75
91
Agencies adherence to international
standards for requirements
92
82
Reviewers have a consistent assessment
method
75
91
92
64
Ability to track progress of application
67
91
92
36
Participation in international workshops/
conferences
50
91
83
73
Adherence to target timelines during review
92
82
83
64
Agencies adherence to international
standards for requirements
92
82
75
82
Summary basis of previous approvals:
Detailed information (eg, EPAR or FDA
review)
Ability to negotiate timing of CPP
submission
Availability of different assessment
routes (eg, priority, orphan status,
standard, abridged or full review)
Availability of time lines: Detailed
target times for each stage of the
review process
Ability to contact person at the agency
Detailed (technical) therapy area guidance
83
45