ANZTPA getting closer
April 19, 2013
STREAMLINED procedures for
the assessment of OTC medicines
in Australia and New Zealand (PD
Wed) are “a major step towards
establishing a single trans tasman
regulatory agency for
regulatory products,” according to
Parliamentary Secretary for Health
and Ageing, Shayne Neumann.
Effective this week a common
approach for processing medicines
sold over the counter was adopted
in both countries.
“These reforms introduce more
predictability for companies
wishing to supply OTC medicines
in Australia and New Zealand,”
Neumann said.
“The new procedures are largely
administrative but will lead to
greater transparency and a faster
process, without compromising
the level of scrutiny applied to
ensure OTC medicines meet the
exacting standards expected by all
consumers,” he added.
Newumann also detailed other
areas of progress towards the
joint ANZTPA, including the
establishment of a Joint Adverse
Events Notification System for
medicines, giving people online
access to adverse events reporting
for medicines in both countries.
He also cited the finalisation of
plans for a trans-Tasman “early
warning system” which will alert
health professionals and consumers
to safety concerns identified with
medicines and medical devices.
This is scheduled for launch
later this year, whille also under
development is a common “recall
portal” to advise consumers and
health professionals about recalls
of therapeutic products.
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