Hong Kong centre may help fast-track medication approval in mainland China: minister
- Health chief Lo Chung-mau says planned facility in collaboration with Shenzhen will harness ‘real world data’ to speed up approval process
Medication already in use in Hong Kong may be approved in mainland China more quickly with the help of real world data harnessed by a research centre set to be established in collaboration with Shenzhen, the health minister has said.
The use of Hong Kong data showing the drugs’ effectiveness would speed up the approval process over the border, especially for medications for serious or rare diseases on the mainland, Secretary for Health Lo Chung-mau told the Post.
“This will be very influential,” he said, explaining the plan would benefit more patients. “Real world data are created when some drugs have been used preliminarily in clinical settings but are not registered yet. [The companies] can supplement data from clinical trials with the real world data and submit them to a regulatory authority.”
Lo said the research centre would be established under the Greater Bay Area International Clinical Trial Institute located in a new innovation and technology cooperation zone at the border.
The institute would be ready by the third quarter of this year at the earliest, the minister said.
Authorities earlier said the facility would act as a “one-stop clinical trial support platform for medical research institutions” and coordinate clinical trial resources in Hong Kong’s public and private healthcare sectors, including researchers, data banks and laboratories.