THE Therapeutic Goods Administration (TGA) has marked itself down on its key performance indicator (KPI) scorecard for the period 2015-16 in relation to compliance and enforcement matters, but states that it performed to expectations on most other parameters.
The regulatory body said that in respect of the KPI requiring a streamlined and coordinated compliance and monitoring system, it does "not yet have a fully mature compliance and enforcement framework with graduated sanctions and penalties."
There is in place a "sound compliance structure" the report said, but "we do not yet have a range of regulatory tools which allow us to use the full range of compliance approaches."
The organisation has come under repeated fire from industry watchdog Ken Harvey for failure to sanction non-compliant complementary medicine advertisers in what is termed a "light touch" approach, given that that the TGA believed "low-risk" products required no pre-market evaluation and trusted sponsors to obey the rules (PD 08 Nov 16).
While Harvey had quoted figures as high as 80% of products assessed had been found to be non-compliant, Complementary Medicines Australia ceo Carl Gibson said TGA Complaints Resolution Panel statistics quoted were "wildly out of date and do not reflect the current situation" (PD 09 Nov).
However, the TGA itself has highlighted the enforcement angle and has indicated an intention to correct the shortfall.
Most other KPIs were described by the Report as "met".
Visit www.tga.gov.au for details.
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