Co-authored by guest bloggers Alison Scott and Bianca Wu of Howse Williams. Not affiliated with Covington & Burling LLP.

In his 2023 Policy Address on October 25, 2023 (“Policy Address”), the Hong Kong Chief Executive officially proposed to establish a preparatory office for the Hong Kong Centre of Medical Products Regulation (“CMPR”). According to the Policy Address, the preparatory office and the CMPR would be a step toward establishing Hong Kong as a “home grown” drug approval authority with primary evaluation capacity, thereby fostering industry research and development and accelerating the launch of new drugs and medical devices in Hong Kong. It is envisaged under the Policy Address that these changes would drive Hong Kong as an international biomedical hub, making it eligible for membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Hong Kong’s current drug registration regime requires that at least one foreign approval be obtained in support of the registration of a drug (or a biosimilar). For drugs containing a new chemical or biological entity, two or more approvals are required from a list of 36 recognized countries. The Policy Address includes a proposed “1+” mechanism, which would shortcut this process by allowing drugs containing new chemical entities for life-threatening or severely debilitating diseases to be accepted with only one certificate of pharmaceutical product. It is anticipated that this change would cut the approval time for new drugs from 2 years to 7 months. Further efficiency would be gained by centralizing the review and approval authority under the CMPR, rather than relying on the current overlapping powers of the Drug Office, Pharmacy and Poisons Board, and the Legislative Council.

The Policy Address also calls for the establishment of the Great Bay Area International Clinical Trial Institute in the Hetao Collaboration Zone. The Institute will help facilitate clinical trials by providing a one‑stop clinical trial support platform for medical research institutions, collecting clinical trial resources in the public and private healthcare sectors in Hong Kong—including researchers, supporting services, data banks, sample banks, and laboratories—and exploring collaboration and coordination with clinical trial networks in Mainland China. Collaboration between Hong Kong and the Greater Bay Area Zone (GBA) in Guangdong Province envisages more clinical trials and drug reviews being carried out in Mainland China, and also allows Mainland-manufactured drugs to be tested and approved in Hong Kong. In 2020, Mainland China established the GBA, where drugs for which there are clinical need and that are marketed in Hong Kong and Macao can obtain limited local approval prior to being approved in Mainland China.

The new regime is likely to be more efficient if successfully implemented. Realistically, however, the change to the current regime may take some time to accomplish. In the interim, Hong Kong will likely continue to take considerable reference from international drug regulatory authorities while developing its own medical products primary evaluation capacity.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Annie Wang, Kaixin Fan, and Kexin Yang.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.

Photo of Julia Post Julia Post

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act…

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

Photo of Muyun Hu Muyun Hu

Muyun Hu advises multinational and Chinese companies on a range of regulatory, policy, transactional, and litigation matters. Her work focuses on the life science industry, particularly with regard to food, drug, medical device, cosmetic, and other regulated products.