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clinical trial demonstration area. Such a mode of co-operation is easier to manufacture and mass-produce mRNA vaccines in a
Policy recommendations for the governments of Hong Kong and Shenzhen
may be piloted in the three national clinical research centres in the smaller production space; it is also feasible to produce advanced
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GBA, with the possibility of gradually extending to other Grade III medical devices such as surgical robots in small factories as the
Level A hospitals. Relevant hospitals and clinical trials centres can scale of production is smaller. Likewise, pilot batches required in
engage in advanced research projects such as clinical research clinical trials do not take up much space to produce.
involving stem cells.
For the drug registration and product launch stage, whereas
Moreover, to effectively popularise the “Hong Kong-style pharmaceutical companies in Shenzhen may submit an NDA to the
management” and experience in Shenzhen, Shenzhen should NMPA, a body with authority to approve new drugs is absent in
expedite unilateral recognition of qualifications and professional Hong Kong. Hence, new drug applications are currently reviewed
titles of Hong Kong healthcare professionals and biotech and approved under the secondary review approach, in which new
researchers, so that doctors and researchers from Hong Kong drugs must receive approval from at least two drug regulatory
can more easily participate in and even manage biomedical authorities in 32 recognised countries and regions (see Figure 20),
research and clinical trial projects conducted in Shenzhen.

Recommendation 2.5 Establishing production
lines in the Loop and improving the product
launch regime for new drugs in the two cities
For the production stage, we recommend the establishment
of GMP -compliant production lines in the Loop to
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manufacture advanced biotech products and pilot batches,
so as to ultimately establish a pilot batch transformation
cluster for biotech in the GBA. Compared with conventional
biotech products, advanced products may be produced in smaller
factories. For instance, unlike conventional inactivated vaccines, it

69 Including Shenzhen No. 3 People’s Hospital, the First Affiliated Hospital of Guangdong Medical College and Nanfang Hospital of Southern Medical University.
70 The PPB joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2016, which shows that Hong Kong’s manufacturing quality management has reached international
standards. Production lines accredited as GMP-compliant in Hong Kong are also recognised by PIC/S members, including many major drug regulators of the world.
71 The production cycle of Pfizer’s mRNA vaccine lasts 9–13 days, whereas that of Sinovac’s inactivated vaccine lasts more than 40 days. Given the difference in production cycle, the batch
size and factory area also differ.
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