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Chapter 15: Global Regulatory Strategy
agencies. These interactions can help the orga-
nization get to know the future agency review
team, help that team become familiar with the
product’s innovative aspects and gain input on
the proposed strategy.
All regulatory agencies expect companies
to be truthful, transparent, collaborative, sci-
ence-based and patient-focused in all interactions.
Language, Culture and Local Insights
To be successful, it is important companies
understand which documents must be presented in
the local language. This might include packaging,
patient or physician leaflets, clinical summaries, etc.
Holding meetings in the local language can
show respect for the culture, especially where facil-
itated by a representative from the country who is
aware and respectful of specific expectations. For
global companies, this step can be cumbersome.
Local language negotiations or discussion
of highly scientific dossier review aspects also
may be more fruitful in the local language
if the reviewers are less comfortable with an
alternative language.
Some countries have specific format require-
ments, which may extend to electronic format,
paper color for the printed dossier, signatures and
required dossier page numbering, etc. Insights
into each of these requirements will ensure
speedy validation and subsequent dossier review.
Regulatory Authority Meetings
Global organizations may plan to interact with
specific regulatory agencies to gain feedback on
available data and intended next development
process steps. In general, companies will interact
with only a limited number of regulators to get
a sense of their intended action’s likely accept-
ability. Companies intending to market in the
US normally will interact with FDA at defined
milestones similarly, if intending to market
elsewhere, key interactions may include meetings
with EMA (and/or specific national European
regulatory authorities), Japan’s Ministry of Health,
Labour and Welfare, Health Canada, Australia’s
Therapeutic Goods Administration or others. Key
agency meeting considerations may include:
• data reporting impacting benefit-risk
conclusion and requiring review before
advancing to the next phase
• clinical design issues requiring discussion
(e.g., where there is an intention
not to follow regional guidance and
expectations or where a specific
innovation is intended in the trial design)
• defining milestone meetings, e.g., End-
of-Phase 2 (EoP2)
• technical reviews with specific
committees, e.g., biotechnology
products or advanced therapies
• preapproval reviews, e.g., Advisory
Committee Meeting
• presubmission interactions to familiarize
the review team with the dossier
and allow in-person discussion and
clarification ahead of dossier submission
The global product strategy team’s job is to
define the overall corporate product development
strategy, assimilate the feedback from multiple
jurisdictions (and possible stakeholders if joint
HTA advice is also sought) and propose a plan
that takes feedback obtained into account. It is
good practice to document the advice received
and capture why the company chose not to
follow that advice, as this is likely to come up
during the subsequent marketing authorization
application review.
Electronic Submissions
To facilitate submission, navigation and review,
many countries accept electronic dossiers. To
ensure presentation is in a common format,
ICH has agreed on a common format known as
the electronic Common Technical Document
(eCTD).6 The table of contents is consistent
with the CTD, and the document is structured
in HTML format. Since this field is evolving,
current standards should be verified via ICH or
country-specific websites prior to dossier com-
Chapter 15: Global Regulatory Strategy
agencies. These interactions can help the orga-
nization get to know the future agency review
team, help that team become familiar with the
product’s innovative aspects and gain input on
the proposed strategy.
All regulatory agencies expect companies
to be truthful, transparent, collaborative, sci-
ence-based and patient-focused in all interactions.
Language, Culture and Local Insights
To be successful, it is important companies
understand which documents must be presented in
the local language. This might include packaging,
patient or physician leaflets, clinical summaries, etc.
Holding meetings in the local language can
show respect for the culture, especially where facil-
itated by a representative from the country who is
aware and respectful of specific expectations. For
global companies, this step can be cumbersome.
Local language negotiations or discussion
of highly scientific dossier review aspects also
may be more fruitful in the local language
if the reviewers are less comfortable with an
alternative language.
Some countries have specific format require-
ments, which may extend to electronic format,
paper color for the printed dossier, signatures and
required dossier page numbering, etc. Insights
into each of these requirements will ensure
speedy validation and subsequent dossier review.
Regulatory Authority Meetings
Global organizations may plan to interact with
specific regulatory agencies to gain feedback on
available data and intended next development
process steps. In general, companies will interact
with only a limited number of regulators to get
a sense of their intended action’s likely accept-
ability. Companies intending to market in the
US normally will interact with FDA at defined
milestones similarly, if intending to market
elsewhere, key interactions may include meetings
with EMA (and/or specific national European
regulatory authorities), Japan’s Ministry of Health,
Labour and Welfare, Health Canada, Australia’s
Therapeutic Goods Administration or others. Key
agency meeting considerations may include:
• data reporting impacting benefit-risk
conclusion and requiring review before
advancing to the next phase
• clinical design issues requiring discussion
(e.g., where there is an intention
not to follow regional guidance and
expectations or where a specific
innovation is intended in the trial design)
• defining milestone meetings, e.g., End-
of-Phase 2 (EoP2)
• technical reviews with specific
committees, e.g., biotechnology
products or advanced therapies
• preapproval reviews, e.g., Advisory
Committee Meeting
• presubmission interactions to familiarize
the review team with the dossier
and allow in-person discussion and
clarification ahead of dossier submission
The global product strategy team’s job is to
define the overall corporate product development
strategy, assimilate the feedback from multiple
jurisdictions (and possible stakeholders if joint
HTA advice is also sought) and propose a plan
that takes feedback obtained into account. It is
good practice to document the advice received
and capture why the company chose not to
follow that advice, as this is likely to come up
during the subsequent marketing authorization
application review.
Electronic Submissions
To facilitate submission, navigation and review,
many countries accept electronic dossiers. To
ensure presentation is in a common format,
ICH has agreed on a common format known as
the electronic Common Technical Document
(eCTD).6 The table of contents is consistent
with the CTD, and the document is structured
in HTML format. Since this field is evolving,
current standards should be verified via ICH or
country-specific websites prior to dossier com-