TGA launches OTC review
November 29, 2011
THE Therapeutic Goods
Administration has announced the
first stage of its consultation into
the Australian Regulatory
Guidelines for Over-the-Counter
Medicines (AGROM).
The consultation follows the
commencement of a review by the
TGA into the market authorisation
process for OTC medicines which is
expected to introduce revised
processes for OTC medicines.
The TGA said it’s hoped that the
consultation will improve the
AGROM in the provision of clear
and useful information for its
intended audience.
The first stage of the process
involves the release of five
appendices for consultation which
have been chosen on the basis
that they are intended to provide
sponsors with greater clarity on
the data requirements for
submitting effective OTC
applications to the TGA.
The Consultation documents
include: Guidelines on safety and
efficacy aspects of OTC application,
Guidelines on quality aspects of
OTC application, Guidelines on
presentation aspects of OTC
application, Guidelines on OTC
application for new substances,
and Guidelines on OTC application
for specific products.
The closing date for consultation
submissions has been set by the
TGA as 01 February 2012.
MEANWHILE the plan for the
second stage of the consultation
process will see the remaining
ARGOM chapters that are
associated with the process and
format of OTC medicine
applications, as well as postmarket
activities, released for
consultation, once revised
processes have been developed,
consulted on and implemented.
The TGA said submissions will be
reviewed, with feedback provided
online and recommendations
published as outcomes.
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