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Chapter 15: Global Regulatory Strategy
factors within each country, including regulatory
requirements and start-up times.
The unpredictable regulatory environment can
be a major deterrent to global clinical development:
• lack of harmonized requirements and
processes among countries, and unique
data requirements outside international
standards
• variability in acceptability of novel
approaches, e.g., innovative clinical
study designs
• variable and inefficient review of initial
approval and amendment processes
• data acceptance and uncertain ICH
GCP enforcement can raise doubts
about whether trial results will be
acceptable to other agencies
• intellectual property concern barriers
to providing detailed information (e.g.,
CMC) at an early stage
When planning a global clinical development
program, prioritizing markets for commercial-
ization and identifying the steps and regulatory
requirements necessary to achieve this may
influence program design significantly. For
example, if in-country clinical trials are needed
for regulatory approval, it may be possible to
plan the clinical development program to include
these countries in global trials in addition to
in-country trials.
Some countries may require specific local
nonclinical studies or clinical pharmacokinetic
studies prior to starting later-phase studies.
A global Phase 3 program may include local
requirements for ethnicity or a specific percent-
age of patients from each region.
Failure to determine these requirements
prior to starting the registration studies could
result in significant cost implications and delays
in marketing application submissions if they are
not met.
Figure 15-3 provides an example of the reg-
ulatory strategy to reduce approval timelines in
key Asian markets by including these countries
in a global clinical development program.
Figure 15-3. Clinical Development Strategy in Asia
Marketing Approval
(US/EU)
Phase 3
Marketing Approval
Launch IND or CTA Phase 1 Phase 2
NDA
NDA
NDA
NDA
NDA
Drug Lag
2endash.case2.5 Years
“save 2endash.case3 years”
TW: Meet DOH Briding
Requirement
KR: Meet KFDA Briding
Requirement
CN: Meet China
Requirement
Dose Finding
Source Country CPP
to start NDA
application
US/EU
Japan
Taiwan
Korea
China
CTA: Clinical Trial Approval
CPP: Certificate of a pharmaceutical product
IND or CTA Phase 1 Phase 2
Chapter 15: Global Regulatory Strategy
factors within each country, including regulatory
requirements and start-up times.
The unpredictable regulatory environment can
be a major deterrent to global clinical development:
• lack of harmonized requirements and
processes among countries, and unique
data requirements outside international
standards
• variability in acceptability of novel
approaches, e.g., innovative clinical
study designs
• variable and inefficient review of initial
approval and amendment processes
• data acceptance and uncertain ICH
GCP enforcement can raise doubts
about whether trial results will be
acceptable to other agencies
• intellectual property concern barriers
to providing detailed information (e.g.,
CMC) at an early stage
When planning a global clinical development
program, prioritizing markets for commercial-
ization and identifying the steps and regulatory
requirements necessary to achieve this may
influence program design significantly. For
example, if in-country clinical trials are needed
for regulatory approval, it may be possible to
plan the clinical development program to include
these countries in global trials in addition to
in-country trials.
Some countries may require specific local
nonclinical studies or clinical pharmacokinetic
studies prior to starting later-phase studies.
A global Phase 3 program may include local
requirements for ethnicity or a specific percent-
age of patients from each region.
Failure to determine these requirements
prior to starting the registration studies could
result in significant cost implications and delays
in marketing application submissions if they are
not met.
Figure 15-3 provides an example of the reg-
ulatory strategy to reduce approval timelines in
key Asian markets by including these countries
in a global clinical development program.
Figure 15-3. Clinical Development Strategy in Asia
Marketing Approval
(US/EU)
Phase 3
Marketing Approval
Launch IND or CTA Phase 1 Phase 2
NDA
NDA
NDA
NDA
NDA
Drug Lag
2endash.case2.5 Years
“save 2endash.case3 years”
TW: Meet DOH Briding
Requirement
KR: Meet KFDA Briding
Requirement
CN: Meet China
Requirement
Dose Finding
Source Country CPP
to start NDA
application
US/EU
Japan
Taiwan
Korea
China
CTA: Clinical Trial Approval
CPP: Certificate of a pharmaceutical product
IND or CTA Phase 1 Phase 2