Page 82 - OHKF_Biotech_EN

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and item by item”, it is not necessary to declare every item for cooperation between the ethic committees of both cities and
Policy recommendations for Central Ministries and Departments
review, except specified ones requiring approval, so as to facilitate explore the application of Hong Kong regulations and standards at
the reform of key areas. the Loop. Furthermore, cooperation between ethics committees in
the two cities and foreign countries and regions, such as the US
To create a biomedical powerhouse in the Loop for the GBA and and the EU, should be promoted to bridge their ethics review rules
even the entire nation, we recommend that the Shenzhen and standards.
Municipal Government seek the approval of the Central
Government on implementing comprehensive authorisation in
the Loop, followed by the Hong Kong and Shenzhen | Bridging the two cities’ systems
governments jointly seeking the authorisation of various and regimes
ministries and departments to implement pilot policies in
biotech reform. Examples include improving drug approval
procedures, facilitating the sharing of human genetic resources, Recommendation 6.1 Relaxing regulations
streamlining the cross-border flow of research materials and set by the Negative List to allow designated
devices, and supporting the testing and certification of drugs and enterprises to enter the Mainland market
medical devices which have yet to complete clinical research The two cities have yet to harmonise their regulations on market
procedures at eligible institutes at the Loop, etc. To ensure the access. In Hong Kong, enterprises from the two cities are on an
smooth implementation of comprehensive authorisation, and to equal footing as Mainland enterprises are not subject to any
launch pilot measures of biotech system and regime reform, restrictions. However, under the Mainland’s restrictions on market
appropriate fault tolerance mechanisms and effective incentivising access, besides existing restrictions that forbid persons of foreign
measures should be put in place in the Loop. nationalities to act as the legal representative of public institutions
and private non-enterprise units, the Negative List of foreign
A biotech expert advisory committee consisting of
government representatives and top-notch professionals investment in China (2020) promulgated by the National
within China and from overseas should be established in the Development and Reform Commission and the Ministry of
Loop to put forward specific recommendations on the Commerce bars foreign investors from investing in the
development of the biotech industry, as well as exploring issues development and application of human stem cells, genetic
like ethics review procedures and mutual recognition of clinical trial diagnostics and therapy technology. As Hong Kong is designated
results and standards, and drug application review and approval as a “foreign” region, it is difficult for Hong Kong enterprises
procedures, etc. To improve the ethics review of clinical trials in specialised in genetic diagnostics and therapies to enter the
Hong Kong and Shenzhen, the advisory committee can foster Mainland market.

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