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Bernard M Y Cheung

Bernard M Y Cheung

University of Hong Kong, Hong Kong

Title: Title: How are new drugs registered and regulated in Hong Kong, a special administrative region of China?

Biography

Biography: Bernard M Y Cheung

Abstract

Hong Kong is a special administrative region in South China enjoying a high degree of autonomy. Its GDP per capitais about the same as the European Union average and higher if adjusted for purchasing power parity. Despite its highpopulation density and unequal wealth distribution, infant mortality is low and life expectancy is long. The hospital-basedhealth service is well-developed but health service delivery in the community is not, and relies on private medical practitioners.This model has its deficiencies but is clearly cost-effective while maintaining high professional standards. Drug registrationtakes reference from American and European requirements. Hong Kong is part of the Pharmaceutical Inspection Co-operationScheme. Drug regulation is rigorous, as shown in the recent orderly recall of contaminated generic Valsartan. The Hong KongHospital Authority Drug Formulary is also closely regulated. New drugs have to demonstrate not just safety and efficacy, butalso advantages over existing drugs and in some instances, cost-effectiveness. Hong Kong is also a national and regional centrefor clinical trials because the subjects are mostly Chinese while protocols in English do not need to be translated. There aretwo clinical trials centres in university hospitals that also run phase 1 and pharmacokinetic studies. The ethical framework andpharmacy support for clinical trials is well established.