Hong Kong health authorities have approved two new cancer treatment drugs, a month after the government introduced a streamlined process to speed applications for the use of pharmaceutical products in the city.
“[The approvals] demonstrated the effective operation of the new 1+ mechanism and the realisation of the policy objective of ‘good drugs for Hong Kong’,” a bureau spokesman said.
“[It marks] an important milestone for Hong Kong in the progressive development into an internationally recognised regulatory authority for drugs and medical devices and an international health and medical innovation hub.”
Hong Kong patients could benefit from faster ‘1+’ drug approval: health minister
Hong Kong patients could benefit from faster ‘1+’ drug approval: health minister
The names and manufacturers of the drugs would be released later in an update to the website for the Pharmacy and Poisons Board, it added.
The bureau said the medications were used to treat metastatic colorectal cancer and were intended for patients for whom traditional chemotherapy treatments were “ineffective or inapplicable”.
The streamlined mechanism was rolled out on November 1 after the government promised to speed up the application process for new drugs that could treat rare or life-threatening diseases.
Hong Kong joins global drug regulation body as observer, health chief ‘delighted’
Hong Kong joins global drug regulation body as observer, health chief ‘delighted’
Medical specialists had previously argued that the old system took too long to approve drugs, since the process relied on pharmaceutical firms gaining approval from two or more of the 36 drug regulatory bodies in mainland China and overseas.
The streamlined mechanism allows pharmaceutical companies producing drugs for rare diseases or cancers to secure approval from just one drug regulatory authority, so long as the application is supported by local clinical data.
In October, Secretary for Health Lo Chung-mau said that the new regulatory regime could cut the time needed to approve new drugs from two years to seven months.
The new mechanism is part of a larger push to boost the city’s reputation as a centre for medical innovation.
The government had said it eventually plans on rolling out its own “primary evaluation” process for drugs and medical devices, rather than relying on other regulatory authorities.
The health minister earlier estimated that it could take between eight and 10 years to establish a domestic drug regulatory authority that is internationally recognised under the Swiss-based International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
