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TGA should be more open about approvals and monitoring, says panel

26-Jul-2011

The Australian Therapeutic Goods Administration (TGA) should be more transparent about its market authorisation decisions, monitoring and compliance practices according to a panel set up to examine the regulators inner workings.

The recommendations, which are detailed in a document on the TGA website , are part of a ‘pro-active’ strategy suggested by the group, which was established last year by Catherine King MP, the Parliamentary Secretary for Health and Ageing.

The Panel considers that it is necessary for the TGA to recognise that it serves multiple stakeholders and that it must adapt its communication strategies accordingly. Consumers and health practitioners has as much interest in therapeutic goods as the industry that produces and markets those goods

The group’s recommendations, which also include making the TGA’s adverse events database searchable by the public, are in keeping with policies adopted by the US Food and Drug Administration and the European Medicines Agency (EMA) in recent years.