Australian Government - Department of Health and Ageing

Health Technology Assessment

Post market surveillance

The aim of Post-Market Surveillance (PMS) is to identify whether health technologies continue to be as safe, effective or cost effective as when originally approved for market entry or reimbursement, or as compared to new health technologies under assessment. PMS also aims to report adverse events and apply vigilance to marketed technologies to ensure manufacturers, sponsors, health care providers and users are aware of these events.

There are currently three main areas where PMS is conducted for Australian Government programs:

  1. The Therapeutic Goods Administration (TGA) plays a major role in the functions of PMS. The TGA evaluates the safety and performance of therapeutic goods (medicines, biological products, devices and prostheses) which have TGA approval for supply and use in Australia. The TGA also manages reported adverse events of these goods in practice. The TGA is also responsible for managing the spontaneous adverse event reporting schemes for therapeutic products and for monitoring the safety of therapeutic products included on the Australian Register of Therapeutic Goods (ARTG).
  2. The TGA undertakes proactive post-market surveillance that is based on data from agencies such as the National Joint Replacement Registry (NJRR). The NJRR, established in 1998, defines improves and maintains the quality of care for people receiving joint replacement surgery. The NJRR was initially funded by the Australian Government, but is now moving to cost recovery from the device manufacturing sector. The NJRR is a model for future development of other registers.
  3. The Comprehensive Management Framework for the MBS (CMFM) announced in the 2011-12 Budget has subsumed the former MBS Quality Framework. The CMFM has two components (i) MSAC providing independent expert advice to the Government on all new and amended MBS services; and (ii) rolling reviews of the quality, safety and fee levels of existing MBS items.
The HTA Review made several recommendations regarding improving PMS. Due to the cost of implementing these recommendations, they are currently subject to further consideration by Government.

Adverse event reporting for medicines

Adverse event reporting for medical devices

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Page currency, Latest update: 26 September, 2011