A life-cycle approach to monitoring benefits and harms of medicines

Emily Banks and Sallie-Anne Pearson
Med J Aust 2012; 197 (6): . || doi: 10.5694/mja12.11028
Published online: 17 September 2012

Collection of high-quality data and management of risk are ongoing needs

Regulatory agencies worldwide are giving greater recognition to postmarketing surveillance, as part of a life-cycle approach to maintaining safety of medicines.1,2 This approach involves monitoring the potential benefits and harms of each medicine, and managing risks, throughout development, preregistration testing, registration and postmarket use in the community.

  • Emily Banks1
  • Sallie-Anne Pearson2

  • 1 National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT.
  • 2 Faculty of Pharmacy, University of Sydney, Sydney, NSW.



Emily Banks is supported by the National Health and Medical Research Council. Sallie-Anne Pearson is supported by the Cancer Institute NSW.

Competing interests:

No relevant disclosures.


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