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September 25, 2014
by Louise Zornoza

Australia’s TGA Launches Web-based ADR Reporting

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

 

Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers.

The new web-based reporting service is one of a range of TGA initiatives targeting consumers which include:

According to published research, about 90-95% of medicines-related adverse events globally are not reported to regulatory authorities, in large part because there is a low awareness among consumers of available ADR reporting systems. In 2013, only about 3% of ADR reports received by the TGA came from consumers, compared with 55% from pharmaceutical companies, 17% from state and territory health departments, 10% from hospitals and hospital pharmacists and the remainder from community pharmacists and general practitioners.

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