TGA signs for e-apps
February 27, 2014
The Therapeutic Goods
Administration (TGA) will use
Lorenz’s docuBridge software for
electronic applications (PD breaking
news 26 Feb).
The contract provided “several
deliverables” for roughly $1.1m
over five years, the TGA said.
One of the first deliverables
was an implementation plan, and
the TGA said it would work with
stakeholders this year to introduce
the system.
The software would be used
to receive, review and process
e-applications for the entry of
medicines and other products
on the Australian Register of
Therapeutic Goods; this would be
an opt-in system, the TGA said.
“The regulated industry currently
incurs substantial costs when they
submit large volumes of paper
documentation to support their
applications.”
Industry would not need to
purchase the software, although
many would be familiar with
it already in its use with other
regulators, the TGA said.
“The TGA will make available
a validation tool available and
submissions created with any
software package can be validated
before submission to the TGA.”
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