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has not yet been accredited): in particular, the Animal Laboratory “the health of our community”, “thus helping its members to avoid
Policy recommendations for the governments of Hong Kong and Shenzhen
of the Centre for Biopharmaceutical Safety Evaluation newly the need to spend time in our hospitals whenever possible”, but it
established by the Shenzhen Institute for Drug Control came into does not seek to achieve this goal with advanced research or
operation in April 2021 in the Nanshan Science and Technology clinical trials. Therefore, even though many hospitals in Hong Kong
Park; the GLP Drug Safety Testing Center of the Hong Kong have taken part in clinical trials, only three have set up clinical
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Science and Technology Parks is expected to come into operation trial centres to systematically manage and develop clinical trials.
in early 2022. Meanwhile, GLP laboratories that can conduct large Compared with other regions, these centres are under-funded,
animal tests are few and far between. There are eight NMPA- leading to sluggish development (see Table 8). Unlike HA
accredited laboratories authorised to conduct experiments on hospitals, Grade III Level A hospitals in mainland China (i.e., its
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non-rodents in both Shanghai and Beijing, compared to none in top-ranked hospitals) are strong advocates of scientific research,
Hong Kong and Shenzhen. To build up comprehensive ancillary with equal emphasis on research, healthcare and education, and
facilities for preclinical research in the area, we recommend that hospitals are evaluated based on their research input and output. 60
the two governments establish GLP laboratories, particularly
those that can conduct large animal experiments, in the Loop. In Hong Kong, applications for Phase I trials are subject to a
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processing time as long as half a year; in Shenzhen, the
governmental approval part of the applications are handled by
Recommendation 2.3 Expediting the NMPA with a maximum processing time of 60 days. In Australia,
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approval of Phase I clinical trials in Hong Kong a hotspot for Phase I trials, applications can be approved in about
30 days. In Hong Kong, Phase I applications must go through two
The next stage, clinical trials, can be completed either in Hong
Kong or Shenzhen. Given that Hong Kong’s internationalised steps: step one is to apply for approval with the hospital’s Ethics
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clinical trial management system has better international Review Committee (ERC), which can take about three months;
recognition, and that fewer number of study participants are step two is to apply for the Certificate for Clinical Trial/Medicinal
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involved in the first phase, Phase I trials may be completed entirely Test with the Department of Health (DH)’s Drug Office, which can
in Hong Kong. Yet, clinical trials in Hong Kong is subject to all take two to three months. Both applications can be submitted
kinds of limitations, and the HA has not attached enough simultaneously, but on one hand, the relevant review committee
importance to it. Of particular note, the HA’s vision and mission of the Pharmacy and Poisons Board (PPB) have merely nine
speak of “providing high-quality [healthcare] services” to maintain members holding only five meetings a year, and on the other,
the content reviewed by the two organisations overlap.

58 The reproductive systems of non-rodents are more similar to that of human, and therefore experiments with non-rodents are more valuable for reference. Non-rodent species include animals
other than the orders of Rodentia and Lagomorpha.
59 The three hospitals are Queen Mary Hospital, Prince of Wales Hospital and the Hong Kong Sanatorium & Hospital.
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