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specific requirements for applications of clinical trials. As such, enterprises. Shenzhen, for its part, has released a plan to
the DH should make reference to the world’s major drug regulators encourage its healthcare institutions to apply to become clinical
and publicise the relevant guidelines, while making sure that ERCs trial organisations and enhance the standards of clinical research.
of the hospitals are well aware of, and take full consideration of, the
guidelines while reviewing the applications. As the nation continues to roll out these measures, Hong Kong
should seize the opportunities to collaborate with Shenzhen and
coordinate cross-border multicentre clinical trials in the Loop.
Recommendation 2.4 Coordinating multicentre By making full use of the reputational advantage of Hong
clinical trials with “Hong Kong-style” management Kong’s internationalised clinical trial management system, the
city can introduce the “Hong Kong-style” management model
As Phase II and III clinical trials require more study participants, they
are often conducted in a global multicentre setting. It is unfeasible for into the Mainland via the Loop to enhance its alignment with
these trials to be completed solely in Hong Kong due to insufficient international standards. A good case in point is the University of
number of cases. Therefore, in addition to improving staffing at the Hong Kong-Shenzhen Hospital, whose establishment helps
DH’s Drug Office to shorten processing time for local Phase II and introduce Hong Kong’s advanced and international management
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III trials, Hong Kong should also encourage collaboration between system to the Mainland. For clinical trials, Hong Kong can rely on
local clinical trial centres and hospitals in Shenzhen. relevant platforms or organisations in the Loop, such as the Clinical
and Translational Medicine Research Centre to be built by the
The National Development and Reform Commission is currently University of Hong Kong-Shenzhen Hospital in the Shenzhen park,
implementing a “1+N+X” mode of collaborative innovation network or the University of Hong Kong Clinical Trials Centre (China) Limited
for clinical research in Shenzhen, in which “N” refers to building to be established by the HKU Clinical Trials Centre, to introduce
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up a collaborative network in clinical research consisting of health relevant experience into Shenzhen, or even the entire GBA. Such
and medical institutions within Shenzhen and beyond, including organisations can also coordinate clinical trial centres in Hong Kong
top-notch institutions from Hong Kong, with a view to provide a and Shenzhen hospitals or other Phase II and III trial centres of
grand collaborative platform in clinical research for biomedical hospitals located in the GBA so as to develop the Loop into a

Although DH’s application guide for the Certificate for Clinical Trial/Medicinal Test does list documents to be submitted, the relevant requirements, such as those to be fulfilled in the preclinical
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research stage, are not specified.
“1” refers to the establishment of an internationally competitive translational medicine research centre by the Shenzhen Academy of Medical Sciences; “N” refers to building up a collaborative
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network in clinical research consisting of health and medical institutions within Shenzhen and beyond to provide a grand collaborative platform in clinical research for biomedical enterprises;
“X” refers to seizing the opportunities the Central Government has conferred to Shenzhen as a pilot reform area with comprehensive authorisations, so as to foster the transfer and application
of advanced technology and basic medical research outcomes in Shenzhen.
“Implementation Plan on Reform to Optimise the Steady Supply of Generic Drugs and Usage Policy in Shenzhen” by the Shenzhen Municipal Government.
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68 Wholly invested by the Shenzhen Municipal Government, the University of Hong Kong-Shenzhen Hospital came into operation in October 2012 to introduce HKU’s modern management
system into the Mainland, including medical appointments, division of primary and specialist care, fixed fees and rates etc.
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