Hong Kong’s Legislative Council Panel on Health Services will today consider recommendations aimed at improving the safety of the drug supply, including the establishment of a dedicated Centre for Drug Safety.
Hong Kong’s drug approval process also needs to be speeded up and all companies involved in repackaging should be required to hold a manufacturing license, says the final report of the Review Committee on the Regulation of Pharmaceutical Products, which was set to up investigate the effectiveness of current controls and regulations following a number of safety incidents involving locally-made drugs.
Following a nine-month investigation, the committee report concludes that the framework and rationale behind Hong Kong’s existing drug safety regime are sound and should be retained, but that the coverage and depth of regulation needs to be strengthened. At the same time, it emphasises the pivotal role played by drugmakers in protecting the integrity of the drug supply, through upholding discipline and professional standards, said the Permanent Secretary for Food and Health, Sandra Lee, who chaired the panel.
The committee report’s 75 recommendations also include upgrading Hong Kong’s Good Manufacturing Practice (GMP) standards to a higher international level and tightening the qualification requirements of drugmakers’ “authorised persons,” with improved training and a longer period of mandatory industrial experience.
Manufacturers should also be required to implement microbiological monitoring during the production of non-sterile drugs, it adds.
On the pre-market control of drugs, the report says the term “poison” on product labels should be replaced by alternatives such as “prescription drugs” and “drugs under supervised sale.”
Wholesalers and retailers dealing with non-poison drugs should be required to apply for a licence, and wholesalers must keep transaction records for all pharmaceutical products, including Part II poisons and non-poisons, it says. Moreover, the Pharmacy and Poisons Board should have powers to revoke the licences of Authorised Sellers of Poisons.
A Code of Practice should be established for wholesalers, importers and exporters, with tougher penalties for violations of the regulations, and the tracking system for drugs imported for re-export needs to be strengthened.
Regarding the procurement and supply of pharmaceutical products in the public and private medical sectors, the review committee calls on the Hospital Authority (HA) and the Department of Health (DH) to require suppliers to provide detailed information such as pack size and registration number on the delivery documentation and improve the current levels of drug quality checks, while retailers and doctors should keep written records for drug orders in order to prevent errors during delivery. The HA and DH should also encourage the private sector to follow the proposed set of guiding principles on the handling of medicines, it says.
In the area of post-market controls, the review committee calls on the DH to maintain rigorous surveillance of high-risk products and enhance pharmacovigilance activities. It should also set up a dedicated team to co-ordinate efforts in drawing up guidelines on risk communication, performing risk assessment in response to incidents, recommending risk communication actions and providing more information on drugs to the public.
Hong Kong’s Secretary for Food and Health, York Chow, has welcomed the report, saying that its recommendations will help raise the standards of the pharmaceutical industry and enhance medicines regulation.
