THE Pharmaceutical Society of Australia (PSA) in its submission had highlighted to the Sansom Review of Medicines and Medical Devices Regulation that it would like to see a greater emphasis on pharmacovigilance activities.
Consequently it has now welcomed the government's response to the Review, in particular the Panel's recommendation "to develop a more comprehensive post-market monitoring scheme for medicines and medical devices and to include, for example, better integration and timely analysis of available datasets, including analysis of matched data from the Pharmaceutical Benefits Scheme (PBS) and other relevant datasets."
PSA national president Joe Demarte also noted the government's acceptance of the Panel's recommendation to review the Scheduling Policy Framework.
"PSA supported the recommendation to provide for the development of a formal risk-benefit methodology to assess scheduling applications in a streamlined manner and to enhance input from interested parties into the scheduling process," he said.
The Review recommended a review of principles and practices around advertising of medicines in Australia and the scrutiny of advertising against a suitable code under a single complaints review body.
"PSA also supports the recommendation to review the advertising framework for therapeutic goods, including better management of complaints, Demarte said.
"We look forward to working with the Government on designing the implementation of the recommendations and to assist in delivering benefits from this important program of reform to improving the health of all Australians," he concluded.
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