OTC set for less regulation
November 18, 2011
THE business reform process
currently underway for the overthe-
counter medicines sector is set
to lessen regulation of OTC drugs,
bringing “significant benefits in
medicine approvals and timelines”
according to the Australian Self
Medication Industry (ASMI).
Speaking about the reform
process at ASMI’s national
conference in Sydney this week, Dr
Rohan Hammett, the National
Manager of the Therapeutic Goods
Administration, told delegates that
“You are going to see greater clarity
from the TGA on what you are
required to do.
“You will see greater predictability,
faster approvals, and we will be
working much more closely with
our international counterparts,
adopting similar approaches to
regulation of over-the-counter
medicines,” he added.
Hammett warned delegates that
previous reform processes by the
TGA for other sectors have resulted
in “a loss of flexibility in processes
that have arisen over decades”, but
that this loss of flexibility “is more
than outweighed by the
predictability, clarity and efficiency
of the regulatory environment”.
MEANWHILE Hammett said that
manufacturers should brace for
greater public scrutiny.
“One very bad marketing idea can
do a lot of damage to trust that has
been built up in our attempts to
improve health literacy,” he said.
The above article was sent to subscribers in Pharmacy Daily's issue from 18 Nov 11To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 18 Nov 11
