Sound familiar? Following several drug "incidents," Hong Kong is beefing up its drug regulatory arm. Although a nine-month investigation finds that the existing framework is "sound and should be retained," a report sent to the Legislative Council Panel on Health Services this week says "the coverage and depth of regulation needs to be strengthened," according to a government announcement.
The report includes 75 recommendations. Among the more familiar-sounding: strengthening the tracking system for drugs; surveillance of high-risk products and enhanced pharmacovigilance activities; and the development of guidelines on risk assessment and communication in response to drug incidents.
More fundamentally, the report recommends upgrading the current Hong Kong GMP standard to a higher international standard and requiring microbiological monitoring for non-sterile drugs during manufacture. Also recommended is licensing of repackagers and wholesalers, improving drug quality checks; and tougher penalties for those who violate the regulations.
- here's the announcement