TGA shakes up structure
June 28, 2010
FROM 01 Jul the Therapeutic
Goods Administration will launch
its new organisational structure,
designed to meet the needs and
challenges “of the 21st Century”.
The new structure will see the
TGA’s offices arranged into three
groups, based on their area of
regulatory oversight: the Market
Authorisation Group; Monitoring
and Compliance Group and the
Regulatory Support Group.
Aimed at cuting down on
duplication of common services,
the new structure will also build on
the TGAs existing knowledge base
and improve the organisation’s
regulatory cohesiveness.
Under the changes the TGA also
aims to provide a more strategic
approach to the use of information
technology within its regulatory
operations.
The TGA has advised that whilst
the new structure’s transition
phase will commence from the
beginning of Jul, it will be
maintaining its current regulatory
services, and that healthcare
professionals and industry bodies
should feel “no significant impact
on access to the TGA’s business
systems and regulatory services”.
The TGA is also advising the
industry that, despite the shake-up,
its main points of contact will
remain the same, and that businesses
should continue to liaise with their
current TGA contacts for all their
“day-to-day business needs”.
MEANWHILE the TGA has
published its new summary of
evaluation fees and charges for
prescription medicines, over the
counter medicines, complementary
medicines, listed medicines and
blood, blood components and
human tissues, registered devices
and listed devices.
Effective from 01 Jul, the new
fees and charges also cover the
license application fee for Good
Manufacturing Practice as well as
a range of other ‘Miscellaneous
fees and charges’ including Low
Value, Low Volume exemptions
and Advertising.
For more information on the
TGA’s structural changes or its
updates fee lists see www.tga.gov.au.
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