Global Pediatric Development of Drugs, Biologics, and Medical Devices
119
Introduction
This chapter provides an overview on the regula-
tion of pediatric medicines and medical devices
in Australia and New Zealand. In addition
to describing the legal framework governing
medicines and medical devices for children, the
chapter also summarizes pediatric labeling and
market access issues.
Background
In spite of many pediatric medicine initiatives
through professional and government advisory
bodies, formal legislative and regulatory reforms
addressing pediatric medicines are still missing in
Australia and New Zealand.
Providing children with better access to safe
and effective medicines to address their thera-
peutic needs has been widely recognized, yet a
true regulatory framework has not been estab-
lished. However, regulators in both countries
have found efficient ways of addressing unmet
pediatric development needs within the existing
regulatory framework, which will be further
discussed in the following sections.
Regulation of Pediatric Medicines in
Australia
Legal Framework
Pediatric medicines in Australia are regulated
within the general framework of the Therapeutic
Goods Act 1989, as amended, and the Therapeutic
Goods Regulations 1990, as amended.
In contrast to the EU and the US, there
is no statutory requirement for a sponsor of a
marketing authorization application to gain
agreement with the Australian Therapeutic
Goods Administration (TGA) on a dedicated
pediatric investigation plan as a prerequisite for
marketing authorization.
However, in line with International
Conference of Harmonisation (ICH)
Harmonised Guideline M4E(R2) Efficacy
adopted by TGA,1 efficacy and safety in the
pediatric population should be routinely analyzed
in applications for a proposed adult indication
that also occurs in children. Thus, TGA will by
default assess whether a new medicine is likely
to be used in children and whether the dosage
form(s) proposed are age-appropriate for the
pediatric population.
Information related to pediatrics should be
provided in all Category 1 comparable over-
seas regulators (CORs)-based applications to
register:2
• New chemical entities
• New combinations
• Extensions of indications
• Major variations
TGA may deny or delay approval if pediatric
data is not included in a marketing authoriza-
tion application for a new medicine where it is
deemed appropriate. Thus, it is recommended
Regulations—Australia and
New Zealand
By Kathrin Schalper, PhD, RAC
11
119
Introduction
This chapter provides an overview on the regula-
tion of pediatric medicines and medical devices
in Australia and New Zealand. In addition
to describing the legal framework governing
medicines and medical devices for children, the
chapter also summarizes pediatric labeling and
market access issues.
Background
In spite of many pediatric medicine initiatives
through professional and government advisory
bodies, formal legislative and regulatory reforms
addressing pediatric medicines are still missing in
Australia and New Zealand.
Providing children with better access to safe
and effective medicines to address their thera-
peutic needs has been widely recognized, yet a
true regulatory framework has not been estab-
lished. However, regulators in both countries
have found efficient ways of addressing unmet
pediatric development needs within the existing
regulatory framework, which will be further
discussed in the following sections.
Regulation of Pediatric Medicines in
Australia
Legal Framework
Pediatric medicines in Australia are regulated
within the general framework of the Therapeutic
Goods Act 1989, as amended, and the Therapeutic
Goods Regulations 1990, as amended.
In contrast to the EU and the US, there
is no statutory requirement for a sponsor of a
marketing authorization application to gain
agreement with the Australian Therapeutic
Goods Administration (TGA) on a dedicated
pediatric investigation plan as a prerequisite for
marketing authorization.
However, in line with International
Conference of Harmonisation (ICH)
Harmonised Guideline M4E(R2) Efficacy
adopted by TGA,1 efficacy and safety in the
pediatric population should be routinely analyzed
in applications for a proposed adult indication
that also occurs in children. Thus, TGA will by
default assess whether a new medicine is likely
to be used in children and whether the dosage
form(s) proposed are age-appropriate for the
pediatric population.
Information related to pediatrics should be
provided in all Category 1 comparable over-
seas regulators (CORs)-based applications to
register:2
• New chemical entities
• New combinations
• Extensions of indications
• Major variations
TGA may deny or delay approval if pediatric
data is not included in a marketing authoriza-
tion application for a new medicine where it is
deemed appropriate. Thus, it is recommended
Regulations—Australia and
New Zealand
By Kathrin Schalper, PhD, RAC
11