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Hong Kong regulators may be beefing up GMPs

This article was originally published in The Gold Sheet

Executive Summary

A review of Hong Kong's drug regulatory infrastructure could lead to more stringent GMP requirements for pharmaceutical manufactures, importers and distributors. A number of recent incidents have shaken public confidence in Hong Kong's regulatory system. The incidents ranged from drugs with fabricated expiration dates to tainted products distributed through government-run hospitals that have been linked to the deaths of six cancer patients. Under current regulations, manufacturers are responsible for registering locally made products. For imported products, the registration burden falls on the importer. Generic drugs that have been registered for more than five years do not have to produce clinical or scientific documentation on efficacy. Hong Kong regulators have enlisted the help of Australian drug experts to guide them in setting manufacturing standards for pharmaceuticals

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