AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 16 of 25
for a long time and that those results are considered important information for consumers in selecting complementary medicines to be used. Nevertheless, the
TGA has always announced review outcomes which may result in adverse reaction andor product recall ANAO, 2011.
In order to provide information associated with listing compliance review to consumers the TGA will make the information available to public through the
provision of publicly-viewable elements on the ARTG. This information will include the complementary medicines that have been reviewed as part of the
post-market monitoring program as well as the review outcomes DoHA, 2011.
4.1.6 Permitted coded indications project
The trigger for this reform associated with permitted indications project is the increased rate of inappropriate claims made about listed complementary
medicines by the sponsors. This reform is closely related to the previous reform which is ‘Update to the listed medicines electronic application portal’ section
4.1.3 since it has the same reason and purpose for the reforms to be taken ANAO, 2011.
Accordingly, the TGA will improve the permitted indications for listed complementary medicines through addition of new indications obtained from
the evaluation of claims frequently made by sponsors in the free-text field on the ARTG DoHA, 2011.
4.1.7 Investigation process for advertising breaches
Great number of breaches in complementary medicine advertising such as prohibited terms use and unpermitted claims are currently exist in many media
including a widely used media, internet. The TGA holds a major responsibility in managing advertising breaches compared to other national agencies
associated with advertising e.g., the Therapeutics Goods Advertising Code Council TGACC and the Complaints Resolution Panel CRP. It was
identified that the TGA did not specify a timeframe to complete investigations
AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 17 of 25
of advertising violations which resulted in two recommendations ANAO, 2011.
To address the finding and recommendations the TGA have planned a number of measures in order to improve the investigation process for advertising
violations which include DoHA, 2011:
Implementation of standard operating procedure for investigating advertising breaches
Development of timeframes to complete investigations of advertising
breaches
Periodic reporting of the investigation progress to the TGA Executive
It is planned to take four years for the Blueprint reforms to be completely implemented. This four years implementation period is divided into 3 phases as
follows TGA, 2012:
Phase 1 January – June 2012: better managing our communication
Phase 2 July 2012
– June 2013: better managing our practice
Phase 3 July 2013 – December 2015: mature and sustainable performance
Based on the Blueprint Implementation Schedule the implementation of complementary medicine reforms is scheduled to finish in phase 2 with the following
details: Table 1. Implementation schedule of complementary medicines reforms
Work Streams Phase 1
– January 2012 to June 2012
Phase 2 – July 2012 to June 2013
Complementary Medicines
Publication of key
guidance documents
Improved guidelines and information
Post market compliance reforms
Procedures for investigating advertising breaches
Source: TGA, Delivering Reforms – Implementation plan for TGA Reforms: A
blueprint for TGA’s future
AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 18 of 25
4.2 Impact of Complementary Medicines Reforms to the Industry and the
