200
Chapter 15: Global Regulatory Strategy
reporting requirements are predicated on both
local and global monitoring programs.
Safety scientists, therefore, must find ways
to capture, record and analyze huge amounts
of safety information across different studies,
systems and jurisdictions and coordinate this
information globally to meet reporting require-
ments, make informed recommendations and
implement decisions.
Global pharmacovigilance processes and
workflow are supported most effectively by
using a global pharmacovigilance system as
a technology tool for drug safety detections,
data mining, results interpretation and deci-
sion-making support. Such systems are trans-
forming industry’s capability to detect safety
signals early as a key component of meeting
regulatory authorities’ postapproval require-
ments and demonstrating a commitment to
safety that transcends regulatory compliance.
An example of a global technology system
supporting improved safety monitoring is shown
in Figure 15-5.5
It is important to acknowledge a global
technology system is a support tool and must
be used within the global policy and procedure
framework to establish a culture of safety and
quality and provide the expertise and resources at
both the global and local level.
Globally, these will include:
• establishing functional groups and
expertise
• developing and aligning integrated
operational procedures
• developing and implementing well-de-
fined decision-making models, esca-
lation processes and communication
channels
• incorporating continuous improvement
activities
These principles apply regardless of the organiza-
tion’s size, the number of products or number of
jurisdictions. Newly launched products generally
are the focus of key postapproval monitoring.
There are notable examples of products with-
drawn from the market many years after initial
launch due to long-term safety studies initiated
after a series of spontaneous reports alerted regu-
lators to potential concerns.
Opportunities exist for greater international
collaboration among regulators who potentially
have access to bigger pharmacovigilance datasets
and data mining capabilities, as well as increased
collaboration and harmonization on regulatory
decisions. The next wave in this workflow is the
introduction of artificial intelligence to enhance
data mining and uncover new insights from large
data sets.
Maintenance and Compliance
Throughout the lifecycle, product registration
must be maintained in accordance with regula-
tions in each jurisdiction in which it is approved.
Variations to the current approved product may
require a submission and regulatory authority
approval, depending on the nature of the pro-
posed change. Similarly, the approval timelines,
and such provisions as grace periods (for imple-
mentation), vary widely in different regions.
Whenever proposed changes are planned,
e.g., a quality change such as a packaging change,
they ideally should be planned well in advance
of implementation. A global plan is required,
including an understanding of region-specific
requirements for the proposed variation, e.g.,
data requirements, submission format, time-
lines and costs. It is good practice to assess the
change’s intended impact and benefit, e.g., a
minor change in manufacturing may take more
time and effort to introduce than the savings in
efficiency intended locally in the plant.
Similarly, changes relating to new clinical
data availability to extend the approved indica-
tions may be planned well ahead of time at both
the global and local levels.
As with new product submissions, a spon-
sor may elect to compile a core global variation
dossier, accessible via a central database, with
local requirements added at a regional or country
level. The submission then is managed at the
Chapter 15: Global Regulatory Strategy
reporting requirements are predicated on both
local and global monitoring programs.
Safety scientists, therefore, must find ways
to capture, record and analyze huge amounts
of safety information across different studies,
systems and jurisdictions and coordinate this
information globally to meet reporting require-
ments, make informed recommendations and
implement decisions.
Global pharmacovigilance processes and
workflow are supported most effectively by
using a global pharmacovigilance system as
a technology tool for drug safety detections,
data mining, results interpretation and deci-
sion-making support. Such systems are trans-
forming industry’s capability to detect safety
signals early as a key component of meeting
regulatory authorities’ postapproval require-
ments and demonstrating a commitment to
safety that transcends regulatory compliance.
An example of a global technology system
supporting improved safety monitoring is shown
in Figure 15-5.5
It is important to acknowledge a global
technology system is a support tool and must
be used within the global policy and procedure
framework to establish a culture of safety and
quality and provide the expertise and resources at
both the global and local level.
Globally, these will include:
• establishing functional groups and
expertise
• developing and aligning integrated
operational procedures
• developing and implementing well-de-
fined decision-making models, esca-
lation processes and communication
channels
• incorporating continuous improvement
activities
These principles apply regardless of the organiza-
tion’s size, the number of products or number of
jurisdictions. Newly launched products generally
are the focus of key postapproval monitoring.
There are notable examples of products with-
drawn from the market many years after initial
launch due to long-term safety studies initiated
after a series of spontaneous reports alerted regu-
lators to potential concerns.
Opportunities exist for greater international
collaboration among regulators who potentially
have access to bigger pharmacovigilance datasets
and data mining capabilities, as well as increased
collaboration and harmonization on regulatory
decisions. The next wave in this workflow is the
introduction of artificial intelligence to enhance
data mining and uncover new insights from large
data sets.
Maintenance and Compliance
Throughout the lifecycle, product registration
must be maintained in accordance with regula-
tions in each jurisdiction in which it is approved.
Variations to the current approved product may
require a submission and regulatory authority
approval, depending on the nature of the pro-
posed change. Similarly, the approval timelines,
and such provisions as grace periods (for imple-
mentation), vary widely in different regions.
Whenever proposed changes are planned,
e.g., a quality change such as a packaging change,
they ideally should be planned well in advance
of implementation. A global plan is required,
including an understanding of region-specific
requirements for the proposed variation, e.g.,
data requirements, submission format, time-
lines and costs. It is good practice to assess the
change’s intended impact and benefit, e.g., a
minor change in manufacturing may take more
time and effort to introduce than the savings in
efficiency intended locally in the plant.
Similarly, changes relating to new clinical
data availability to extend the approved indica-
tions may be planned well ahead of time at both
the global and local levels.
As with new product submissions, a spon-
sor may elect to compile a core global variation
dossier, accessible via a central database, with
local requirements added at a regional or country
level. The submission then is managed at the