OTC reforms welcomed
April 3, 2013
The Australian Self Medication
Industry (ASMI) has welcomed
the implementation of reforms
following an extensive review of
the business processes regarding
the evaluation of OTC medicines in
Australia and New Zealand.
“The decision to align the
administrative process for
evaluation of OTC medicines in
readiness for the joint agency
(ANZTPA) scheduled for 2016
makes good sense,” said ASMI
Scientific and Regulatory Affairs
Director, Steve Scarff.
According to ASMI, the reforms
will result in more efficient and
cost-effective processes, greater
transparency and predictability and
improved clarity in relation to the
regulatory requirements for OTC
medicine applications.
These reforms relate only to the
administrative processes employed
by the regulators.
They do not alter the standards
applied or the assessment of the
risks and benefits associated with
new and changed OTC medicines.
“We’ve worked with the TGA
and Medsafe for the past 18
months to help bring about more
streamlimed, transparent and
predictable processes which are
based on a sound risk management
approach,” said Scarff.
The new administrative
procedures will start from 15 April
2013 and will be rolled out over the
next 12 months.
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