Increasing Regulations on Drugs in Hong Kong

After a rash of incidents leading to patient deaths in Hong Kong hospitals in 2009, a review committee has developed 75 recommendation points aimed at improving the safety of prescription drugs. Under the Food and Health Bureau (FHB) and Department of Health (DH)’s supervision, a comprehensive review was published in 2010.

One of the first recommendations includes upgrading the current Hong Kong GMP standards to a higher international standard. Currently, Hong Kong is adopting the GMP standard promulgated by WHO in 1995. The Review Committee recommends that the GMP standard be first upgraded to the standard promulgated by WHO in 2007. After approximately two years, the Review Committee suggests upgrading to an even higher standard devised by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Other recommendations include microbiological monitoring for non-sterile drugs during the manufacturing process, tightening up the qualifications of the Authorization Person (AP) by increasing the required number of years of industrial experience, requiring all companies involved in repackaging to have a manufacturing license, requiring bioavailability and bioequivalence studies for drug registration, etc. The Review Committee also recommended introducing a Code of Practice for wholesalers, importers, and exporters, and to strengthen the tracking system for drugs imported for re-export purpose.

The government is currently following up on these recommendations to determine actions plans and implementation strategies. FHB will oversee the policy issues, and together with the DH, will take forward the necessary legislative amendments, address the resource needs and requirements involved.