Trans-Tasman early warning
March 11, 2013
THE Therapeutic Goods
Administration and NZ’s Medsafe
have released details of a Trans
Tasman early warning system of
safety concerns for medicines and
medical devices.
The program is outlined in a new
paper, detailed on the TGA website
for consultation, titled The Trans-
Tasman early warning system: How
the process will work in Australia
and New Zealand.
According to the paper, the
purpose of the program is to
establish a trans-Tasman early
warning system for advising the
public about potential safety
concerns associated with medicines
and medical devices.
In designing the system the TGA
and Medsafe consulted with the
United States Food and Drug
Administration, Health Canada and
Health Singapore regarding their
current alerting systems for
medicines, and also held a series of
workshops in Melbourne, Sydney
and Wellington which were
attended by consumer, health
professional, government and
industry stakeholder
representatives.
The Early Warning System will be
based on four principals: ‘Timely’,
‘Sustainable’, ‘Responsive’, and
‘Engaging’.
According to the plan, there are
several points in the therapeutic
product vigilance process where
the decision to issue a
communication can be made.
“Two different types of
communication are possible:
monitoring communication and an
alert communication,” the report
said.
“The decision to issue a
monitoring communication can be
made either at: the initial
assessment/risk analysis step when
all safety concerns are considered
and may be communicated; or
the signal investigation/assessment
step when concerns deemed to be
safety signals are considered and
may be communicated,” the report
added.
All the monitoring communications
issued will have a subsequent
communication advising the
outcome of the safety concern.
The decision to issue an alert
communication will be made at the
conclusion of the signal
investigation/assessment and will
be made independent of whether a
monitoring communication was
issued or not, the report said.
In addition, follow up
communication(s) may be issued
after a monitoring communication
and prior to a final communication,
however these will be assessed on
a case-by-case basis.
Meanwhile, monitoring
communications are intended to
highlight potential safety concerns,
stimulate adverse event reporting,
and instruct users to follow the
manufacturer's product information/
instructions for the medicine or
medical device (where applicable).
The paper is now open for
consultation until 07 April, for more
information, or to view the paper
see www.tga.gov.au.
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