Letters | How Hong Kong’s new drug regulator can give the city a competitive edge
Readers discuss the potential of the Centre for Medical Products Regulation, and the struggles of fast-food chains
To attract investment and talent to Hong Kong, the CMPR needs to offer value on top of existing initiatives. One Greater Bay Area scheme, in particular, allows drugs and devices adopted in Hong Kong or Macau to gain expedited access to mainland China through Guangdong province.
As of April, 51 drugs and 63 devices have been approved under the scheme. Between April 2023 and September 2024, 18 of the drugs were approved in four batches. For context, Hong Kong registered around 400 new medicines in the past year alone.
According to our analysis, most of the 18 drugs were first approved in the United States through priority or orphan drug pathways to treat serious conditions. Eight drugs obtained Hong Kong approval within two years of US approval. The CMPR could enable Hong Kong to launch more new drugs within an earlier global window.
By September 2024, the median time for approval under the Greater Bay Area measure had fallen to around six months. After Guangdong adopted provincial legislation, this timeline has been compressed to 10 days. Macau, meanwhile, has emerged as a competitive entry point, with five drugs approved there before Hong Kong.
Eight of the 18 drugs subsequently obtained national approval, on average within 21 months of their initial approval in Hong Kong or Macau. As pharmaceutical companies increasingly prioritise early launches in mainland China, fewer drugs will have sufficient lead time to make effective use of the Greater Bay Area measure.