Medication already in use in Hong Kong may be approved in mainland China more quickly with the help of real world data collected by a research center to be established in collaboration with Shenzhen, Hong Kong's Secretary for Health Lo Chung-mau told the South China Morning Post. 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. “This will be very influential,” Secretary Lo 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.”
Secretary Lo said the research center 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, he 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.
The government announced in its 2023 policy address the goal to develop Hong Kong into a health and medical innovation hub. Under the plan, authorities hoped to attract more pharmaceutical corporations to conduct research and development (R&D) and clinical trials in the city. Lo said the research center would mostly target Hong Kong-registered drugs that were approved for urgent clinical use at designated healthcare institutions in the Greater Bay Area under a policy introduced in collaboration with mainland authorities in 2021. He said only drugs for serious conditions and with few alternatives were accepted under the 2021 policy. “While mainland authorities have not given its full approval, the drugs are allowed to be used among a certain group of people. As we can prove its quality, safety and efficacy, in addition to the clinical trial data, the time required for approval can be shortened.”
Professor Ian Wong, former Dean of the University of Hong Kong’s Department of Pharmacology and Pharmacy, supported Lo’s plan, saying the center could help pharmaceutical corporations save on the time required to conduct another clinical trial on the mainland. He said there was a gap in data involving the Chinese population as clinical trials for most drugs were conducted in Western countries. That gap could be filled by the center using real world data in Hong Kong, Wong added, as reported by the South China Morning Post.
