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such as the use of chemicals during the drug discovery stage Center Network (ICN), which gives it the same stature as the
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and quality control and manufacturing of pilot batches in clinical clinical trials centres of Harvard University and Cambridge
trials, all of which need to be in compliance with GMP. University. Many leading global pharmaceutical companies like
AstraZeneca and Pfizer have conducted clinical trials in Hong
The major drug regulatory and management organisations Kong. Meanwhile, Shenzhen is home to a number of mature
mentioned above usually include the Food and Drug pharmaceutical companies like Hepalink Pharmaceutical, Kangtai
Administration (FDA) of the US, the European Medicines Agency Biological Products, Chipscreen, etc. It also attracts large
(EMA), and the National Medical Products Administration (NMPA) international pharmaceutical companies like Sanofi Pasteur to
of China, etc. In Hong Kong, preclinical research, clinical trials, establish research and production facilities there.
production and approval for product registration are under the
purview of the Pharmacy and Poisons Board (PPB) of Hong Kong To unleash the competitive edges the two cities enjoy in drug
and the Drug Office of the Department of Health (DH), the development, the government departments concerned should
Board’s executive arm. Yet the scale of the PPB is significantly proactively attract or encourage enterprises that have completed
smaller than the three aforementioned regulators and it also does preclinical research to conduct clinical trials in the two cities.
not have any independent capacity for new drug approval. Under our recommendations, Phase I trials will be conducted in
Hong Kong’s clinical trials centres (see Recommendation 2.3).
Upon their completion, mature companies can apply for listing in
| Drugs and vaccines Hong Kong after fulfilling the HKEX’s listing requirements, while

Drug and vaccine innovation is a critical part of the biomedical other companies can establish a presence in the Hong Kong
industry, and also one of its most lucrative sub-sectors. Hong Science Park or the Loop to take advantage of supportive
Kong is internationally renowned for its clinical trial prowess, with incubating measures such as venue and equipment provision,
many specialties in four local hospitals having received NMPA funding from the two cities and business matching, etc. (see
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approval to conduct clinical trials of drugs. Additionally, clinical Recommendation 1.2) Thereafter, as the companies move
trials conducted in various hospitals of Hong Kong have forward with Phase II and III trials using a multicentre approach,
frequently won the recognition of the FDA and EMA. The HKU they will engage medical intermediaries or Contract Research
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Clinical Trials Centre affiliated with Queen Mary Hospital, in Organisations (CRO) in the Loop to coordinate and manage
particular, is a founding member of the International Clinical Trial clinical trials involving the joint effort of numerous hospitals in

30 A pilot batch is produced during the product development stage for quality testing purposes. For biotech products, a pilot batch is primarily produced for use in clinical trials.
31 Including Queen Mary Hospital, Prince of Wales Hospital, Hong Kong Eye Hospital, and Hong Kong Sanatorium & Hospital.
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