Hong Kong Announces New Drug Registration Process – “1+” Mechanism

In the past, drug registration in Hong Kong required that a foreign drug had approval in 2 reference countries. Late last year, the Hong Kong Department of Health announced the “1+” mechanism which now allows drug approval if the drug has been approved in only 1 reference country (not 2), and the drug is also bolstered with some local clinical data. This new program is geared towards innovative lifesaving drugs, drugs for severe illnesses, and drugs for unfulfilled medical needs. Hong Kong hopes this new registration process will let patients get quicker access to new drugs and help lead to more clinical studies and drug development in Hong Kong.

Accordingly, the Hong Kong Department of Health utilized this new “1+” mechanism in late December to approve 2 new drugs both for metastasized colorectal cancer. Hong Kong has also now established a new office called the Center for Medical Product Regulation (CMPR) which hopes to further expedite the approvals of medical products locally.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.