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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
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Clinical study protocol design also may
influence data acceptability in different jurisdic-
tions. Regulatory guidance on developing new
therapies for specific indications will influence
overall study design, including objectives, end-
points, use of active comparators or placebo and
study duration. In an effort to support conduct of
clinical studies to meet requirements in both the
EU and US, EMA and FDA provide organiza-
tions the opportunity to seek parallel Scientific
Advice. The goal of parallel Scientific Advice is
sharing information and perspectives, rather than
necessarily resulting in harmonization of regula-
tory requirements. However, for innovative new
products for which no specific guidance is avail-
able, agreement on development requirements
may be a beneficial outcome. Increasingly, it
also is desirable to obtain advice in parallel with
reimbursement authorities to drive alignment
in what the regulatory authority and subsequent
reimbursement authorities would prefer to see in
the overall evidence package.
Dossier
Core Dossier
Regulatory agencies expect an assurance of
medicines’ quality, safety and efficacy before they
authorize their distribution to patients in their
countries.
While the information required by each
country’s regulators differs, ICH has developed
some harmonization of standards among coun-
tries. In addition to the three ICH regions (US,
Europe and Japan), many countries have adopted
ICH guidelines, including Australia, Switzerland
and Canada.
ICH has developed a standard content for-
mat, the Common Technical Document (CTD),
that also is organized with consistent sections
and headings2 (see Figure 15-4).
Module 1 is for administrative information
and prescribing information and should con-
tain region-specific documents, e.g., application
forms or the proposed regional label. Module 1
is outside the formal ICH guidelines, and each
Figure 15-4. The CTD Triangle
Module 1
Regional
Administrative
Information
CTD Table of Contents
2.1
CTD Table of Contents
2.2
Quality
Overall
Summary
2.3
Nonclinical
Overview
2.4
Clinical
Overview
2.5
Clinical
Summary
2.7
Nonclinical Written and
Tabulated Summaries
2.6
Module 3
Quality
Module 4
Nonclinical
Study Reports
Module 5
Clinical Study
Reports
Module 2
Not part of the CTD
CTD
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
Clinical study protocol design also may
influence data acceptability in different jurisdic-
tions. Regulatory guidance on developing new
therapies for specific indications will influence
overall study design, including objectives, end-
points, use of active comparators or placebo and
study duration. In an effort to support conduct of
clinical studies to meet requirements in both the
EU and US, EMA and FDA provide organiza-
tions the opportunity to seek parallel Scientific
Advice. The goal of parallel Scientific Advice is
sharing information and perspectives, rather than
necessarily resulting in harmonization of regula-
tory requirements. However, for innovative new
products for which no specific guidance is avail-
able, agreement on development requirements
may be a beneficial outcome. Increasingly, it
also is desirable to obtain advice in parallel with
reimbursement authorities to drive alignment
in what the regulatory authority and subsequent
reimbursement authorities would prefer to see in
the overall evidence package.
Dossier
Core Dossier
Regulatory agencies expect an assurance of
medicines’ quality, safety and efficacy before they
authorize their distribution to patients in their
countries.
While the information required by each
country’s regulators differs, ICH has developed
some harmonization of standards among coun-
tries. In addition to the three ICH regions (US,
Europe and Japan), many countries have adopted
ICH guidelines, including Australia, Switzerland
and Canada.
ICH has developed a standard content for-
mat, the Common Technical Document (CTD),
that also is organized with consistent sections
and headings2 (see Figure 15-4).
Module 1 is for administrative information
and prescribing information and should con-
tain region-specific documents, e.g., application
forms or the proposed regional label. Module 1
is outside the formal ICH guidelines, and each
Figure 15-4. The CTD Triangle
Module 1
Regional
Administrative
Information
CTD Table of Contents
2.1
CTD Table of Contents
2.2
Quality
Overall
Summary
2.3
Nonclinical
Overview
2.4
Clinical
Overview
2.5
Clinical
Summary
2.7
Nonclinical Written and
Tabulated Summaries
2.6
Module 3
Quality
Module 4
Nonclinical
Study Reports
Module 5
Clinical Study
Reports
Module 2
Not part of the CTD
CTD