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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
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• Alternate formats—some regions, like
the Association of Southeast Asian
Nations (ASEAN) require their own
dossier format (e.g., the ASEAN
CTD). This format incorporates both
summaries and detailed reports into
one part, e.g., Part IV includes both
the clinical summary and clinical
study reports. Formatting at a practical
level can be as specific as the color
of the tabs between sections or page
numbering, and care must be taken to
meet these formatting requirements for
countries retaining these specific dossier
validation needs.
An alternative commercial strategy may
require tailoring the dossier, e.g., where differ-
ent data are required to register attributes for a
specific market.
• Quality differences—registering
alternative presentations, manufactur-
ing sites or supply routes in a specific
country, different release specifications
or humidity and temperature conditions
requiring alternative storage or stability
data.
• Clinical differences—intention to
register an alternative indication or
additional local data. This data inclusion
may require a new clinical review or
modification of other sections, e.g., inte-
grating new data into safety summaries
and summary tables. Some markets also
may require clinical data comparing
the product to that market’s current
standard of care.
• Timing difference—depending on when
the original filing is submitted, a cur-
rent dossier version incorporating the
sequence of changes that have occurred
may be required. For this purpose, good
practice is to keep a ‘current master ver-
sion’ in addition to tracking versions and
content registered in each market.
Planning Filing Sequence Across Global
Markets
The dossier generation and filing sequence
planning strategy is the regulatory professional’s
Table 15-2. Overview of Specific Country Requirements
Country Global
Dossier
Local Trials Local Language CPP
Required
Specific Requirement
US ICH CTD Representative ethnic mix English No Patient-level data
Integrated
Summary of Safety and
Efficacy
EU ICH CTD Representative ethnic mix English, plus local language
required for product
information
No
Japan ICH CTD Required Japanese No
Australia ICH CTD Generally No, except
bioequivalence studies using
local product as comparator
English No Australian-specific Risk
Management Plan
China Local format Required Chinese (Mandarin) Yes Extensive dossier
required for clinical
trial approval
South
America
Mixed—ICH
CTD and
local format
Mixed—some countries
require local data, some
do not
English, plus local language
required for product
information
Mixed
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
• Alternate formats—some regions, like
the Association of Southeast Asian
Nations (ASEAN) require their own
dossier format (e.g., the ASEAN
CTD). This format incorporates both
summaries and detailed reports into
one part, e.g., Part IV includes both
the clinical summary and clinical
study reports. Formatting at a practical
level can be as specific as the color
of the tabs between sections or page
numbering, and care must be taken to
meet these formatting requirements for
countries retaining these specific dossier
validation needs.
An alternative commercial strategy may
require tailoring the dossier, e.g., where differ-
ent data are required to register attributes for a
specific market.
• Quality differences—registering
alternative presentations, manufactur-
ing sites or supply routes in a specific
country, different release specifications
or humidity and temperature conditions
requiring alternative storage or stability
data.
• Clinical differences—intention to
register an alternative indication or
additional local data. This data inclusion
may require a new clinical review or
modification of other sections, e.g., inte-
grating new data into safety summaries
and summary tables. Some markets also
may require clinical data comparing
the product to that market’s current
standard of care.
• Timing difference—depending on when
the original filing is submitted, a cur-
rent dossier version incorporating the
sequence of changes that have occurred
may be required. For this purpose, good
practice is to keep a ‘current master ver-
sion’ in addition to tracking versions and
content registered in each market.
Planning Filing Sequence Across Global
Markets
The dossier generation and filing sequence
planning strategy is the regulatory professional’s
Table 15-2. Overview of Specific Country Requirements
Country Global
Dossier
Local Trials Local Language CPP
Required
Specific Requirement
US ICH CTD Representative ethnic mix English No Patient-level data
Integrated
Summary of Safety and
Efficacy
EU ICH CTD Representative ethnic mix English, plus local language
required for product
information
No
Japan ICH CTD Required Japanese No
Australia ICH CTD Generally No, except
bioequivalence studies using
local product as comparator
English No Australian-specific Risk
Management Plan
China Local format Required Chinese (Mandarin) Yes Extensive dossier
required for clinical
trial approval
South
America
Mixed—ICH
CTD and
local format
Mixed—some countries
require local data, some
do not
English, plus local language
required for product
information
Mixed