Hong Kong to Set Up Own Drugs, Medical Devices Watchdog This Year, Chief Executive Says
Zhang Yushuo
DATE:  7 hours ago
/ SOURCE:  Yicai
Hong Kong to Set Up Own Drugs, Medical Devices Watchdog This Year, Chief Executive Says Hong Kong to Set Up Own Drugs, Medical Devices Watchdog This Year, Chief Executive Says

(Yicai) May 13 -- Hong Kong is on track to establish the Center for Medical Products Regulation, its own independent drug regulator, by the end of this year, according to the chief executive of the special administrative region.

If Hong Kong wishes to transform itself into a medical and health innovation hub, it has to quickly expand its clinical trial capabilities and promote the transition of biopharmaceutical research and development from the laboratory to clinical application, John Lee said at the two-day Asia Summit on Global Health ended yesterday.

In June last year, Hong Kong announced it was planning to establish its own drug regulatory authority to support its efforts to become a medical innovation hub. In March this year, the first phase of its 'primary evaluation' scheme for new drug registration came into effect, marking a milestone towards achieving independent drug review and approval by 2030.

Hong Kong does not have a local drug approval agency, which means that many innovative drugs need to first be approved elsewhere before reaching the local market.

In November 2023, the SAR implemented the 'one plus' approval mechanism, which lowered the number of regulatory approvals that drugs need to have for market registration in Hong Kong from two to one if they can provide acceptable local clinical data and obtain recognition from local experts. This shortened the new drug approval times to some extent.

If Hong Kong can reach mutual recognition of new drug approval results with some countries, it will further expedite the market launch process of Chinese innovative drugs and medical devices in those countries, Wu Zhenrong, service industry development director of the Hong Kong Trade Development Council, told Yicai.

The Greater Bay Area International Clinical Trial Institutes in Shenzhen and Hong Kong Park have already been put into operation. The two locations will leverage the Greater Bay Area's population of over 87 million to coordinate and conduct clinical trials to speed up the delivery of new medical technologies to patients.

Editor: Futura Costaglione

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Keywords:   Hong Kong drug regulator,MCHK,innovative drugs,pharmaceutical approval,drug registration,China biotech,Greater Bay Area,clinical trials,market access,regulatory reform