Healthy Skepticism Library item: 19704

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

What's in store for the TGA
Pharmacy Daily 2011 Dec 12
http://www.pharmacydaily.com.au/

Full text:

A comprehensive package of reforms is set to sweep across the
Therapeutic Goods Administration in stages, to enhance the TGA’s current
processes and ensure that its regulatory framework remains able to adapt
to new scientific developments and community expectations.

The reforms are the result of major reviews across various regulatory
areas including: communications and stakeholder engagement; advertising
of therapeutic products; complementary medicines; medical devices; and
promotion of therapeutic goods.

Under the Blueprint, reforms to the TGA’s communications and stakeholder
engagement will see the TGA give priority to actively engaging with the
community and providing improved information and education materials
over the next 12 to 18 months, as well as establishing an Australian
Therapeutic Goods Advisory Council.

Improvements to the advertising of therapeutic goods will include the
creation of a central point for all complaints about advertising; as
well as the development of options for broadening the current
arrangements for pre-approval of ads to include medical devises and
therapeutic goods on TV; and developing a more effective approach to
sanctions and penalties for advertising breaches.

To reduce the level of non-compliance by complementary medicines
sponsors, the Blueprint has said the TGA will (in consultation with
stakeholders) update, and include in the regulations, the /Guidelines
for the levels and kinds of evidence to support indications and claims.

Other complementary medicines regulatory changes include the amendment
of the Electronic Listing Facility to provide increased guidance and
cautionary notes for sponsors about the potential consequences of
providing misleading or unsubstantiated claims, and eliminate sponsors’
access to free text. In terms of medical devices the TGA has said it
will increase the rigor of pre-market regulatory assessment of higher
risk medical devices, and ensure an appropriate level of evidential
review is undertaken to assure safety, quality and efficacy of these
devices.

Changes will also see amendments to the way in which a kind of medical
device is included in the ARTG with the requirement for sponsors to
nominate product names under each ARTG entry for each kind of medical
device, improving the ability of the TGA to facilitate medical device
recalls. Lastly in terms of advertising, the Blueprint said that
Government’s preference is to maintain an emphasis on self-regulation
and that the TGA strongly supports industry’s initiative to harmonise
codes of conduct to incorporate the industry-led working group’s new
framework of high level principles. For more details see www.tga.gov.au.

see also http://www.tga.gov.au/newsroom/media-2011-tga-reforms-111208.htm