Hong Kong 2024 Policy Address: Key Highlights and Advancements in Medical Product Regulation

Hong Kong’s 2024 Policy Address, presented by Chief Executive John Lee on October 16, 2024, emphasizes the Hong Kong government's commitment to enhancing healthcare innovation and access. A key focus is the reform of approval mechanisms for drugs and medical devices, aimed at expediting access to essential treatments and strengthening the biomedical research sector. Since the implementation of the “1+” mechanism in November 2023, which allows for a streamlined registration process for all new drugs, including vaccines and advanced therapy products (ATPs), Hong Kong has received over 260 inquiries from nearly 80 pharmaceutical companies and approved five new drugs, including innovative therapies for cancer and hypercalcemia. In addition to the “1+” mechanism, the Policy Address outlines plans for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) and statutory regulation of medical devices, both of which will strengthen the local regulatory framework and promote a more efficient approval process.

Establishing the Hong Kong Centre for Medical Products Regulation

To further bolster regulatory capacity, the government plans to establish the Hong Kong CMPR. The Preparatory Office for the CMPR, set up on June 5, 2024, will outline a timeline in early 2025 for implementing a “primary evaluation” process. This initiative aims to enhance local regulatory capabilities and promote the growth of the pharmaceutical R&D and testing industries.

Moving Toward Statutory Regulation of Medical Devices

In parallel, the government is preparing to legislate statutory regulation for medical devices, establishing a framework that aligns with international standards. This regulatory structure will provide clarity and consistency, enhancing public trust and ensuring that innovative medical technologies can reach the market efficiently.

The Medical Device Administrative Control System (MDACS), established in November 2004, still plays a crucial role in ensuring the safe use of medical devices. Recent updates to public procurement processes have made MDACS listing essential. As of June 21, 2023, priority is given to MDACS-listed devices in public tenders, with full preference mandated by November 1, 2024. By 2025, all medical devices procured by the Department of Health must be MDACS-listed, streamlining procurement and enhancing market access for manufacturers.

Additionally, obtaining an MDACS listing is essential for companies aiming to enter the Greater Bay Area (GBA) market. Under the GBA Connect Scheme, medical devices publicly procured in Hong Kong public hospitals can be utilized in GBA healthcare institutions, facilitating quicker access to innovative products. For further insights into MDACS and its implications, read our blog post on the MDACS Listing: Key to Hong Kong Public Procurement and GBA Market Entry.

Enhancing Biomedical Research and Clinical Trials: Leveraging GBA Initiatives

The reform initiatives also include collaboration with the Greater Bay Area (GBA) to improve research capabilities. The GBA Clinical Trial Collaboration Platform will enhance access to larger patient pools, while the Real World Study and Application Centre will leverage local health data to facilitate faster regulatory approvals and improve product efficacy assessments. These partnerships will create a more conducive environment for clinical trials and R&D, attracting global pharmaceutical and medical device companies to the region.

Significantly, recent initiatives like the GBA Connect Scheme aim to facilitate the importation of Hong Kong drugs and medical devices into the Greater Bay Area (GBA). As of October 2024, the scheme has designated 45 hospitals across nine mainland GBA cities, significantly increasing access to advanced treatments for residents. Recently, the Guangdong Medical Products Administration approved 79 medical products under this scheme, directly benefiting nearly 10,000 patients. This initiative highlights the ongoing integration of healthcare systems in the GBA and provides a model for future collaborations. For more details on this significant development, you can read our blog post on the 25 New Designated Hospitals and 7th Batch of Approvals.

Further information

The reforms to Hong Kong’s drug and medical device approval system signify a significant advancement in the healthcare landscape. By building on the success of the “1+” mechanism, establishing the CMPR, and preparing for statutory regulation of medical devices, the government is creating a robust regulatory framework. These initiatives support faster access to new treatments and foster a vibrant environment for biomedical innovation. As Hong Kong strengthens its position as a hub for healthcare research and development, these changes are set to benefit both patients and industry stakeholders alike.

Read the Hong Kong Policy Address 2024 for more details.

Contact Cisema to learn more about the “1+” mechanism details and how to swiftly bring your innovative pharmaceuticals to market.

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