TGAs revised scheduling
June 29, 2010
THE Therapeutic Goods
Administration has said that despite
the commencement of the revised
scheduling arrangements for
medicines and chemicals coming
into effect from next month, the
transition to cost recovery will not
be immediate “and is unlikely to be
fully implemented for another
eighteen months or so”.
Designed to improve the
efficiency and timeliness of
scheduling decisions, the new
process will align the scheduling of
medicinal substances with the
therapeutic goods approval process
- meaning that as of 01 Jul the
decision to schedule a drug will be
made within the TGA.
“In most cases this [scheduling
decision] will be a logical
consequence of a product
application containing a new
chemical entity that meets the
scheduling criteria. Alternatively a
scheduling decision may result from
a request to re-schedule a
substance, or as a result of an
identified safety issue,” the TGA
said in a statement.
According to the TGA the
majority of sponsors will notice very
little change in the current
application and approval process,
and they should continue to submit
product applications as per the
current arrangement taking into
account the new Policy
Framework’s guidelines.
The TGA is urging all sponsors
and industry stakeholders to
familiarise themselves with the new
Scheduling Policy Framework for
Medicines and Chemicals,
developed by the National
Coordinating Committee on
Therapeutic Goods.
The SPF sets out the scheduling
process as well as guidence on
amendments, classification
systems, applications,
public consultation, and confidential
info - see www.tga.gov.au.
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