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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
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and registries, will be required. This is especially
true when smaller data packages were initially
relied upon to gain regulatory approval and this
evidence may be required by other stakeholders
such as reimbursement authorities. For countries
with relatively small populations, global coop-
eration among regulatory agencies and global
studies are required to provide the breadth and
depth of additional data required to support
ongoing approval. Overall, this lifecycle man-
agement approach is expected to lead to lower
patient risks compared to the current approach,
despite smaller early data packages.4
The International Coalition of Medicines
Regulatory Authorities (ICMRA), formed in
December 2013, provides a forum for develop-
ing a cooperative approach among regulators on
many topics, including postapproval commit-
ments. This group and other such coalitions of
authorities in multiple jurisdictions can utilize
reliance mechanisms, working together to share
reviews, guidelines and best practices, and can be
useful tools when considering filing strategies.
Safety Monitoring
Clinical product development risk assessment
must be thorough and rigorous. However, it is
impossible to identify all safety concerns during
controlled clinical trials. Once a product is mar-
keted, the number of patients exposed generally
increases dramatically, including those with
co-morbid conditions and/or taking concomitant
medications. Therefore, postmarketing safety data
collection and clinical risk assessment are critical
for evaluating and characterizing a product’s risk
profile and making informed risk minimization
decisions. The growing trend for early approvals
based on less-extensive clinical trial data further
increases this imperative.
Postmarket safety data monitoring now
is a universal regulatory authority requirement
for marketing approval and may include formal
postapproval clinical studies, monitored release
programs and spontaneous reporting programs.
Although these postapproval obligations are
mandated by agencies at the jurisdiction level,
Figure 15-5. Global Technology System for Safety Monitoring
Site Data Entry
Literature and
Spontaneous ADR
Reports
Incoming
ADR
Reports
Clinical Data
System
Clinical Trial
Management
System
Central
Laboratory
System
Global Safety
System
Signal
Detection
Database
External
Regulatory
Database
Regulators
Routine
Reporting
Product Safety Monitoring
Significant
Case
Reports
Case Series Alert
Signals Queries
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
and registries, will be required. This is especially
true when smaller data packages were initially
relied upon to gain regulatory approval and this
evidence may be required by other stakeholders
such as reimbursement authorities. For countries
with relatively small populations, global coop-
eration among regulatory agencies and global
studies are required to provide the breadth and
depth of additional data required to support
ongoing approval. Overall, this lifecycle man-
agement approach is expected to lead to lower
patient risks compared to the current approach,
despite smaller early data packages.4
The International Coalition of Medicines
Regulatory Authorities (ICMRA), formed in
December 2013, provides a forum for develop-
ing a cooperative approach among regulators on
many topics, including postapproval commit-
ments. This group and other such coalitions of
authorities in multiple jurisdictions can utilize
reliance mechanisms, working together to share
reviews, guidelines and best practices, and can be
useful tools when considering filing strategies.
Safety Monitoring
Clinical product development risk assessment
must be thorough and rigorous. However, it is
impossible to identify all safety concerns during
controlled clinical trials. Once a product is mar-
keted, the number of patients exposed generally
increases dramatically, including those with
co-morbid conditions and/or taking concomitant
medications. Therefore, postmarketing safety data
collection and clinical risk assessment are critical
for evaluating and characterizing a product’s risk
profile and making informed risk minimization
decisions. The growing trend for early approvals
based on less-extensive clinical trial data further
increases this imperative.
Postmarket safety data monitoring now
is a universal regulatory authority requirement
for marketing approval and may include formal
postapproval clinical studies, monitored release
programs and spontaneous reporting programs.
Although these postapproval obligations are
mandated by agencies at the jurisdiction level,
Figure 15-5. Global Technology System for Safety Monitoring
Site Data Entry
Literature and
Spontaneous ADR
Reports
Incoming
ADR
Reports
Clinical Data
System
Clinical Trial
Management
System
Central
Laboratory
System
Global Safety
System
Signal
Detection
Database
External
Regulatory
Database
Regulators
Routine
Reporting
Product Safety Monitoring
Significant
Case
Reports
Case Series Alert
Signals Queries