Hong Kong regulators may be beefing up GMPs
This article was originally published in The Gold Sheet
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
You may also be interested in...
Centus Biotherapeutics has received formal European Commission approval for its Equidacent biosimilar rival to Avastin.
The IGBA has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating healthcare professionals.
Data from the first 275 patients in the trial are promising, but outside experts say they are wary of another hasty Emergency Use Authorization.