Chapter 4: Components of Regulatory Strategy – The Basics
56 Regulatory Affairs Professionals Society
with each target market’s release. This presentation
type also is useful for reporting strategy updates.
Should any particular country’s review time
not meet the product plan’s original expectations, a
graphic data presentation should be considered to
determine approximate review times.
Regulatory Submission
Requirements
Regulatory classification, submission type, clinical
data requirement, and estimated review time overview
is helpful. Usually, a tabular presentation works well
(see Table 4-5).
Regulatory Risks
This GRS section should address only those risks
outside typical development and regulatory risks.
These risks may surface due to a lack of information
on a particular topic or direct knowledge of changes
in the regulatory environment. Table 4-6 shows one
way to summarize the possible risks detected during
research.
Areas to Monitor
Every strategy operates under assumptions based on
the product plan and regulatory research results. The
regulatory professional should make a list of these
assumptions and decide when and how they should
be re-verified during the project. These are areas that
will need regular review. Naturally, the items cited in
the regulatory risks section will also be included in a
monitoring plan.
The monitoring frequency for each area should
be integrated into the regulatory plan and assigned to
the appropriate team member(s).
Resources Required
If the analysis finds additional resources will be
required, careful attention must be paid to the presen-
tation for this GRS element. The GRS stakeholder
audience will not necessarily understand the level
of effort required to manage the project’s regulatory
elements effectively.
The timing and resources needed to accomplish
the product plan should be presented. If there is resis-
tance to adding the needed resources, the regulatory
professional should be prepared to offer an alternative
Table 4-4. Expanded Example of the GRS Element Table
GRS Element Company
Expectation
Research
Methodology
Data Needed Analysis Result Presentation
Review times 90 days Quantitative
Qualitative
• Published review times for
similar products (if available)
• Regulatory network
resources—individual
submission experiences
180 days Graphic
Available
standards
Yes Qualitative • International standards list
• Standards accepted in
previous submissions
• Accepted standards
declarations
(country-specific)
Six relevant
standards
Statement (GRS)
Listing
(regulatory plan)
Clinical study
needs
None Qualitative • Guidance documents
• Previous submissions for
competitive products
Performance
standard available.
No clinical data
required.
Statement (GRS)
Provided
(regulatory plan)
Environmental
trends
None Qualitative • Review public meeting
schedules (past and present)
• Guidance documents
planned or pending
• Public health issues
• Legislative activity
Issues identified
with technology in
a different clinical
use
Description
(GRS)
Details for
risk mitigation
(regulatory plan)
Resources None Qualitative and
Quantitative
• Format and content for filings
in each country
• Available staffing levels
Simultaneous
submissions
require additional
regulatory staff
Graphic or
tabular (GRS)
Details for each
filing (regulatory
plan)
56 Regulatory Affairs Professionals Society
with each target market’s release. This presentation
type also is useful for reporting strategy updates.
Should any particular country’s review time
not meet the product plan’s original expectations, a
graphic data presentation should be considered to
determine approximate review times.
Regulatory Submission
Requirements
Regulatory classification, submission type, clinical
data requirement, and estimated review time overview
is helpful. Usually, a tabular presentation works well
(see Table 4-5).
Regulatory Risks
This GRS section should address only those risks
outside typical development and regulatory risks.
These risks may surface due to a lack of information
on a particular topic or direct knowledge of changes
in the regulatory environment. Table 4-6 shows one
way to summarize the possible risks detected during
research.
Areas to Monitor
Every strategy operates under assumptions based on
the product plan and regulatory research results. The
regulatory professional should make a list of these
assumptions and decide when and how they should
be re-verified during the project. These are areas that
will need regular review. Naturally, the items cited in
the regulatory risks section will also be included in a
monitoring plan.
The monitoring frequency for each area should
be integrated into the regulatory plan and assigned to
the appropriate team member(s).
Resources Required
If the analysis finds additional resources will be
required, careful attention must be paid to the presen-
tation for this GRS element. The GRS stakeholder
audience will not necessarily understand the level
of effort required to manage the project’s regulatory
elements effectively.
The timing and resources needed to accomplish
the product plan should be presented. If there is resis-
tance to adding the needed resources, the regulatory
professional should be prepared to offer an alternative
Table 4-4. Expanded Example of the GRS Element Table
GRS Element Company
Expectation
Research
Methodology
Data Needed Analysis Result Presentation
Review times 90 days Quantitative
Qualitative
• Published review times for
similar products (if available)
• Regulatory network
resources—individual
submission experiences
180 days Graphic
Available
standards
Yes Qualitative • International standards list
• Standards accepted in
previous submissions
• Accepted standards
declarations
(country-specific)
Six relevant
standards
Statement (GRS)
Listing
(regulatory plan)
Clinical study
needs
None Qualitative • Guidance documents
• Previous submissions for
competitive products
Performance
standard available.
No clinical data
required.
Statement (GRS)
Provided
(regulatory plan)
Environmental
trends
None Qualitative • Review public meeting
schedules (past and present)
• Guidance documents
planned or pending
• Public health issues
• Legislative activity
Issues identified
with technology in
a different clinical
use
Description
(GRS)
Details for
risk mitigation
(regulatory plan)
Resources None Qualitative and
Quantitative
• Format and content for filings
in each country
• Available staffing levels
Simultaneous
submissions
require additional
regulatory staff
Graphic or
tabular (GRS)
Details for each
filing (regulatory
plan)