190
Chapter 15: Global Regulatory Strategy
Marketing
During all product development stages, the mar-
keting/commercial team contributes to the global
development strategy. To present a product to its
target market, three key elements must be inte-
grated: product attributes, marketing decisions
and commercialization activities. Each of these
may be influenced by the regulatory strategy,
label claims and product presentation.
The integrated product strategy will incor-
porate the overall regulatory and market strat-
egies seamlessly. Key marketing interactions
influencing regulatory strategy and vice versa are
shown in Figure 15-2.
Each territory should contribute to and take
into consideration the global product strategy
when developing regulatory and marketing strat-
egies for local markets.
Global regulatory environment changes
and precedence will impact marketing strategies
directly. International harmonization of regula-
tory requirements is increasing the opportunity
for companies to file and launch new products
simultaneously in multiple markets. Further, the
introduction of live (adaptive) licensing, based on
a medicine’s early approval in a restricted setting
due to positive data in the limited setting and
shifting data generation in broader settings to a
subsequent line extension, will impact the sales
and marketing process significantly. Instead of an
all-or-nothing regulatory approval approach, new
medicines’ approval is replaced by a cumulative
process based on gradual accretion of data (the
‘evidence continuum’). New therapies receive a
conditional license based on further testing to
substantiate their safety and efficacy in larger
or different populations, thus providing early
access to promising therapies, particularly for
unmet needs. Over time, more data are expected
to be generated in the post-license setting, and
access to technology and digital health records
will allow an environment that provides greater
confidence to regulators and other stakeholders
than has been possible before.
Marketing will be able to promote and
build a new brand on an incremental basis.
However, the opportunity for early market
launch also carries the risk that not all products
will have the anticipated benefits, as subse-
quent trials may show a small treatment effect
or unacceptable adverse events. This risk needs
to be communicated to patients and health-
care providers clearly and systems developed
to monitor new medicines in the marketplace
more closely. License cancellation or restriction
risks and consequences should be incorporated
in risk management planning.
Reimbursement
While significant efforts have been directed
toward global harmonization of regulatory
requirements, reimbursement processes and sys-
tems are country-specific, with little or no har-
Figure 15-2. Key Interactions Between Marketing and Regulatory
Clinical
Studies
Regulatory
Approval
Product
Launch Postapproval Basic
Research
Product
potential
Target Product
Profile
Comparators
Outcomes
research
Product labelling
Product
presentation
Filing strategy
Promotion and
branding
Product
extensions
Advertising
Postapproval
studies
Chapter 15: Global Regulatory Strategy
Marketing
During all product development stages, the mar-
keting/commercial team contributes to the global
development strategy. To present a product to its
target market, three key elements must be inte-
grated: product attributes, marketing decisions
and commercialization activities. Each of these
may be influenced by the regulatory strategy,
label claims and product presentation.
The integrated product strategy will incor-
porate the overall regulatory and market strat-
egies seamlessly. Key marketing interactions
influencing regulatory strategy and vice versa are
shown in Figure 15-2.
Each territory should contribute to and take
into consideration the global product strategy
when developing regulatory and marketing strat-
egies for local markets.
Global regulatory environment changes
and precedence will impact marketing strategies
directly. International harmonization of regula-
tory requirements is increasing the opportunity
for companies to file and launch new products
simultaneously in multiple markets. Further, the
introduction of live (adaptive) licensing, based on
a medicine’s early approval in a restricted setting
due to positive data in the limited setting and
shifting data generation in broader settings to a
subsequent line extension, will impact the sales
and marketing process significantly. Instead of an
all-or-nothing regulatory approval approach, new
medicines’ approval is replaced by a cumulative
process based on gradual accretion of data (the
‘evidence continuum’). New therapies receive a
conditional license based on further testing to
substantiate their safety and efficacy in larger
or different populations, thus providing early
access to promising therapies, particularly for
unmet needs. Over time, more data are expected
to be generated in the post-license setting, and
access to technology and digital health records
will allow an environment that provides greater
confidence to regulators and other stakeholders
than has been possible before.
Marketing will be able to promote and
build a new brand on an incremental basis.
However, the opportunity for early market
launch also carries the risk that not all products
will have the anticipated benefits, as subse-
quent trials may show a small treatment effect
or unacceptable adverse events. This risk needs
to be communicated to patients and health-
care providers clearly and systems developed
to monitor new medicines in the marketplace
more closely. License cancellation or restriction
risks and consequences should be incorporated
in risk management planning.
Reimbursement
While significant efforts have been directed
toward global harmonization of regulatory
requirements, reimbursement processes and sys-
tems are country-specific, with little or no har-
Figure 15-2. Key Interactions Between Marketing and Regulatory
Clinical
Studies
Regulatory
Approval
Product
Launch Postapproval Basic
Research
Product
potential
Target Product
Profile
Comparators
Outcomes
research
Product labelling
Product
presentation
Filing strategy
Promotion and
branding
Product
extensions
Advertising
Postapproval
studies