Friday, 7 May 2010

Hong Kong - How will the major regulatory review affect the pharmaceutical market in Hong Kong?

The major review of the regulatory system should bring positive changes to the pharmaceutical market in Hong Kong.

In early 2009, a number of incidents concerning pharmaceutical products in Hong Kong caused public concerns on drug safety. The FHB and the DH took immediate measures to address the concerns, including the inspection of all local drug manufacturers. As a longer term measure, it was decided that a comprehensive review on the existing regime for the regulation of pharmaceutical products should be conducted.

This review, which was published in January 2010, decided to focus on certain areas of the regulatory environment, and identified these as areas for improvement. These are: Good Manufacturing Practice (GMP); pre-market control of drugs; regulations for importers/exporters, wholesalers & retailers; pharmacovigilance and public awareness; and increasing penalties for manufacturers/sellers who disobey the law.

Further reading - An in-depth analysis of Hong Kong's pharmaceutical market is available from Espicom: The Pharmaceutical Market: Hong Kong (published April 2010)

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