TGA biological consultation
November 11, 2010
THE Therapeutic Goods
Administration is seeking written
submissions on proposed
amendments to the Therapeutic
Goods Regulations which will
implement the long-planned
Biologicals Framework.
A consultation paper is currently
online at www.tga.gov.au, which
incorporates a number of
amendments to a version sent by
email to registered stakeholders
late last month.
Issues canvassed include the
proposed biologicals classification
system, separate and distinct
criteria for biologicals, clinical trial
requirements, exemptions in
relation to medical practitioners,
adverse event reporting timeframes,
patient information for biologicals
and an “exceptional release
scheme” for biologicals.
Information sessions on the
proposed amendments are planned
over the next few weeks in Sydney,
Brisbane, Melbourne and Canberra,
as well as videoconferences in Perth
TGA biological consultation
and Adelaide, at which details of
proposed fees and charges for
biologicals will also be discussed.
A separate consultation on the
fees and charges is expected to be
undertaken in the coming weeks.
Interested parties are invited to
provide comment by close of
business on Friday 3rd December.
MEANWHILE the TGA has also
released the submissions that it
received earlier this year relating to
its draft Code of Good
Manufacturing Practice and five
proposed Therapeutic Goods
Orders for blood and blood
components, human tissues and
human cellular therapies.
The feedback has seen significant
revisions to all five standards,
meaning that there will be a second
round of stakeholder consultation.
Areas which have changed
include timing and requirements for
the examination and consent of
living donors, as well as assessment
of microbial contamination.
See www.tga.gov.au.
The above article was sent to subscribers in Pharmacy Daily's issue from 11 Nov 10To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 11 Nov 10
