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.
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- 7. Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet 2008; 372: 2152-2161.
- 8. Panel to Review the Transparency of the Therapeutic Goods Administration. Review to improve the transparency of the Therapeutic Goods Administration. http://www.tga.gov.au/pdf/consult/review-tga-transparency-1101-final-report.pdf (accessed Jun 2012).
- 9. Department of Health and Human Services, US Food and Drug Administration. The sentinel initiative — national strategy for monitoring medical product safety. http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf (accessed Jun 2012).
Emily Banks is supported by the National Health and Medical Research Council. Sallie-Anne Pearson is supported by the Cancer Institute NSW.
No relevant disclosures.