Generics gathering
July 18, 2013
Drug regulators from the Heads
of Agencies Consortium from
Australia, Canada, Singapore and
Switzerland met in Canberra in
May this year to further develop
the processes for generic drug
regulation, with details of the
meeting now on the TGA website.
Progress was made on the issue
of adopting universal quality
assessment templates aligned with
those developed by the EU.
The main focus of discussion
in Canberra was transitioning
from “proof of concept” pilots
to the integration of regulatory
collaboration into routine
business practices and submission
application processes.
Another topic high on the agenda
was the importance of pro-active
engagement with industry and
other stakeholders, including
pharmacists, in order to facilitate
the timely availability of safe,
effective and quality generic drugs.
International staff exchanges were
also identified as important means
of enhancing communication,
understanding and respect.
The ACT meeting was followed
by the larger International Generic
Drug Regulators Pilot (IGDRP), and
the next meeting of the Consortium
Generics Working group will be in
Bern, Switzerland in October 2013.
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