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which do not include mainland China. It is worth noting that
Policy recommendations for the governments of Hong Kong and Shenzhen
the NMPA’s 2015 reform to improve validity of clinical trial data
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has substantially increased clinical data quality in the Mainland.
Also, with the NMPA joining the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) in 2017, the Mainland’s review standards for
drugs and medical devices have become better aligned with
international standards. Yet, Hong Kong has not updated its list
of recognised countries and regions since 2012.

We therefore recommend that the DH review the list and
consider the inclusion of Mainland China and the
recognition of NMPA-approved drugs. Such measure will also
send out a positive message that encourages pharmaceutical
companies in the Mainland to engage in research and register
for new drugs in Hong Kong. Drawing on the experience of the
Advisory Panel on COVID-19 Vaccines established by the Meanwhile, with the implementation of the “Hong Kong
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government during the COVID-19 epidemic, Hong Kong can drug-connect” policy, designated healthcare organisations in the
explore establishing an independent drug review mechanism GBA can now utilise drugs and medical devices already approved
in the long run. By bringing in and training drug review for use in Hong Kong and Macao. The NMPA has also delegated
professionals, particularly multilingual talent well-versed in the authority for approval to the Guangdong Provincial
registration of new drugs and medical devices in the US FDA Government. However, our survey found that, in contravention
and EU EMA frameworks, the city can explore building up of the policy intent to expedite the registration of clinically urgent
independent drug review capabilities. drugs and medical devices, regulators still required applicable

72 The NMPA promulgated the Announcement on Inspection of Clinical Trial Data (2015/117) on 22 July 2015 to subject unapproved drugs that have been reported for production or import to
self-inspection of clinical data. Under the document, 1,622 clinical trial projects are subject to self-inspection, with particular emphasis on stringent standards and monitoring, strict
accountability as well as severe punishment.
73 In November 2020, eight departments including the NMPA issued the “Work Plan on Innovations on Drug and Medical Device Regulation in the GBA”, authorising designated healthcare
organisations in the nine GBA cities in the Mainland to use clinically urgent drugs that have been authorised for use in Hong Kong and Macao. With NMPA agreement, the new arrangement
is for the State Council to authorise the People’s Government of the Guangdong Province to approve the drug use (i.e., Hong Kong drug-connect), with the University of Hong Kong-
Shenzhen Hospital being the first pilot hospital.
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