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Risk Management from an Asian/Pacific Rim Regulatory Perspective

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Abstract

This article reviews the state of adverse drug reaction monitoring in five Asian/Pacific Rim countries (Australia, Japan, Malaysia, New Zealand and Singapore). Each country has an active pharmacovigilance programme managed by a national regulatory agency. Current methods for assessing risks and current methods used for risk management and communication are compared with the ‘tools’ used by the US FDA. Major positive attributes of the programmes in all five countries include active involvement of independent expert clinical advisory committees in identifying and evaluating risks through the assessment of reports of serious and unusual reactions, and regular communications about risks from the national agencies to doctors and pharmacists by means of pharmacovigilance bulletins. Most components of the risk-management toolbox are currently used, in some instances without legislated support. Variations in the way risk-management tools are implemented within individual national health systems are illustrated.

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Acknowledgements

The author has no conflicts of interest that are directly relevant to the content of this review. The manuscript was prepared during the course of the author’s usual employment with the Therapeutic Goods Administration.

The ready assistance of Ms Chie Kojima, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan; Mrs Abida Haq, National Pharmaceutical Control Bureau, Ministry of Health, Malaysia; Ms Sarita von Afehlt, Medsafe, New Zealand; and Ms Cheng Leng Chan and Dr Kang Nee Ting, Health Sciences Authority, Singapore in providing detailed information is gratefully acknowledged.

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  1. Therapeutic Goods Administration, PO Box 100, Woden, ACT, 2606, Australia

    John McEwen

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  1. John McEwen
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Correspondence to John McEwen.

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McEwen, J. Risk Management from an Asian/Pacific Rim Regulatory Perspective. Drug-Safety 27, 491–497 (2004). https://doi.org/10.2165/00002018-200427080-00002

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