The Government announced today that for the first time two new drugs were approved for registration in Hong Kong yesterday after being reviewed under the new mechanism for registration of New Drugs ("1+" mechanism).

 
They are oral targeted drugs in different dosages for treating metastatic colorectal cancer, and bring new hope of treatment to patients for whom conventional chemotherapy has been ineffective or inapplicable, the Government said.

 
It added that the approval of new drugs for registration only around a month after the "1+" mechanism came into effect shows the effectiveness of the new mechanism in enabling the earlier use of new drugs to treat serious or rare diseases.

Furthermore, the Government highlighted, the "1+" mechanism strengthens local capacity in drug evaluation, marking an important milestone for Hong Kong in its development as an internationally recognised regulatory authority for drugs and medical devices and an international health and medical innovation hub.

Under the mechanism, applications for registration of new drugs beneficial for the treatment of life-threatening or severely debilitating diseases and supported with local clinical data only need to submit approval from one reference drug regulatory authority, down from two previously. The new drugs can be registered in Hong Kong after the applications are assessed by local experts and approved by the Pharmacy & Poisons Board of Hong Kong.