Following is a question by the Hon Tang Ka-piu and a written reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (October 22):

Question:

     Some members of the community expect the Government to make more flexible and forward-looking arrangements for drug registration and the provision of drugs to patients. In this connection, will the Government inform this Council:

(1) of the number of new drugs approved for registration in Hong Kong in each of the past three years, with a breakdown by the region where the drug regulatory authorities issuing documentary proofs of registration were located; among such new drugs, of the number of those registered under the "1+" mechanism for approval of new drug;

(2) whether it knows the following information on the assessment of applications for inclusion of new drugs in the Drug Formulary (the Formulary) by the Drug Advisory Committee under the Hospital Authority (HA) in the past five years:

(i) the number of new drug applications received;

(ii) the names of new drugs approved for inclusion in the Drug Formulary;

(iii) the percentage of drug applications approved for inclusion in the Formulary;

(iv) the main reasons for not approving the inclusion of new drugs in the Formulary; and

(v) the average number of days required from receipt of an application to completion of the approval process; the process for re-application after an application has failed to obtain approval, and the average time required for the relevant procedures;

(3) whether it knows if the Drug Advisory Committee has formulated objective and quantifiable criteria for approving new drugs, and whether it will introduce measures to enhance the transparency of the approval process, such as making public the approval process, the specific details of assessment indicators and the operation of the decision-making mechanism;

(4) as there are views pointing out that certain new drugs may cover multiple indications, whether the Government will establish a flexible approval mechanism to relax the approval restrictions on drugs that can be used for treating multiple indications, so that the same drug can be approved expeditiously for use in multiple indications based on different clinical evidence;

(5) as it is learnt that an increasing number of members of the public choose to go north to buy drugs, particularly targeted therapy drugs for treating cancer or rare disease drugs, whether the Government will consider providing support for members of the public to go north to buy drugs, such as partnering with Mainland medical institutions to set up dedicated drug collection points for Hong Kong people or introduce cross-boundary medication delivery services; and

(6) as it is learnt that the Mainland is highly transparent about the prices of anti-cancer and rare disease drugs, with patients able to check the official drug price lists online, whether the Government will consider making reference to the relevant practice to promote drug price transparency, such as piloting the publication of drug prices in public hospitals, so that patients can make informed choices?

Reply:

President,

     Medical innovation can bring the benefits of good drugs and research and development (R&D) to patients. Citizens may benefit from some of the most advanced, effective and up-to-date drugs through innovative R&D, while more drug registrations may also reduce financial pressures on healthcare. The 2025 Policy Address announced that the Hong Kong Special Administrative Region (HKSAR) Government will accelerate the reform of the regulatory system of drugs and medical devices, thereby consolidating Hong Kong's position as an international health and medical innovation hub. Specific initiatives and timelines include:

(a) setting up the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026 and submitting legislative proposal, thereby empowering the CMPR to regulate Chinese medicines, Western medicines and medical devices (medical products), with a view to establishing the CMPR as an internationally renowned regulatory authority for medical products;

(b) enhancing the prevailing evaluation, approval and registration mechanism for drugs and implement "primary evaluation" for new drug registration in phases beginning in 2026;

(c) expediting the "1+" mechanism for new drugs, including piloting priority evaluation and approval of innovative drugs recommended by the Hospital Authority (HA) for treatment of severe or rare diseases; and

(d) submitting a legislative proposal on regulating medical devices to the Legislative Council in 2026, dovetailing with the development of the CMPR.

     Meanwhile, the healthcare services provided at public hospitals under the HA are heavily subsidised by the Government (with an average subsidisation rate of over 97 per cent of the costs) to ensure that citizens are not denied adequate healthcare due to lack of means. With the persistently ageing population and growing prevalence of chronic diseases in Hong Kong, healthcare demand continues to escalate. To cope with the rising demand for public healthcare services, the HA allocates an enormous amount of resources annually to the provision of healthcare services and drugs in order to provide patients with optimal treatments with high subsidies. To ensure the appropriate use of limited public healthcare resources, the HA has put in place a mechanism to introduce new drugs for patients based on clinical evidence and include drugs, having regard to their cost-effectiveness and proven efficacy, in the HA Drug Formulary (HADF), while also monitoring the utilisation and expenditures of drugs in order to drive their prudent use.

     In consultation with the Department of Health (DH) and the HA, the consolidated reply to the question raised by the Hon Tang Ka-piu is as follows:

(1) According to the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with approval from the Pharmacy and Poisons Board of Hong Kong (Board) before they can be sold or supplied in Hong Kong. Applicants for registration of pharmaceutical products are required to submit the necessary documents in accordance with the Guidance Notes on Registration of Pharmaceutical Products/Substances as promulgated by the Board. In general, applicants for registration of pharmaceutical product containing new chemical or biological entities (NCEs, i.e. containing active ingredients which have not been registered in Hong Kong) are required to, in accordance with the Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity as promulgated by the Board, provide documentary proof for registration issued by at least two drug regulatory authorities of specified reference places in order to provide supporting evidence that relevant products have been rigorously evaluated before placing in the market (i.e. the "secondary evaluation" approach).

     To enhance the drug regulatory regime and implement the "primary evaluation" approach in the long run, the Government has launched on November 1, 2023 the "1+" mechanism for approval of new drugs and widened its applicability to all new drugs on November 1, 2024. For pharmaceutical products containing NCEs that are supported with local clinical data and scope of application recognised by local relevant expert, applicants concerned are only required to submit approval from one drug regulatory authority (instead of the two or more) to apply for registration in Hong Kong.

     From 2023 to 2025 (as at September 30), the Board approved a total of 252 applications for registration of pharmaceutical product containing NCEs (the number of applications for registration of pharmaceutical product containing NCEs approved in 2023, 2024 and 2025 were 98, 102, and 52 respectively), and over 85 per cent of documentary proof of the registration submitted by the relevant applicants were issued by drug regulatory authorities of the Mainland, the European Union, Australia, Canada and the United States. Since the implementation of the "1+" mechanism on November 1, 2023, the Board has approved a total of 14 new drugs under this mechanism (two, seven and five products were approved in 2023, 2024 and 2025 respectively).

(2) and (3) The HA has established mechanisms for regular evaluation of registered new drugs and review of the existing drugs listed in the HADF and the coverage of the safety net, as well as assessment on whether medical devices should be introduced into the public healthcare system. The review process is evidence-based, taking into account the safety, efficacy, cost-effectiveness and other relevant considerations, including international recommendations and practices, as well as professional views, so as to ensure that public resources are utilised fairly and efficiently to enable patients to receive appropriate treatment. Drugs and medical devices which meet the safety and efficacy standards required for registration under the regulatory regime for medical products in Hong Kong currently under reform do not necessarily meet the standards for inclusion in public healthcare services. In particular, when introducing innovative drugs or medical devices to the public healthcare system, consideration has to be given to the prioritisation in overall resource allocation and the cost-effectiveness of the innovative drugs and medical devices concerned, including a comparison with the existing treatment options, so as to optimise the use of limited healthcare resources.

     Evaluation of new drugs is an on-going process driven by evolving medical evidence, the latest clinical developments and market dynamics. Under the current mechanism, the HA's Drug Advisory Committee convenes regular meetings to review applications for inclusion of new drugs submitted by doctors or pharmaceutical manufacturers. Over the past five years (i.e. from 2020-21 to 2024-25), a total of 264 applications for inclusion of new drugs in the HADF were received. Of these, 116 applications were approved for inclusion in the HADF, accounting for over 40 per cent of the total number of applications. Details of the drugs involved are listed in the Appendix. The main reasons for applications not being approved for inclusion in the HADF include availability of other alternative drugs in the HADF with comparable benefits, insufficient evidence to demonstrate the long-term efficacy or significant clinical benefits of the drug, and insufficient evidence to support the cost-effectiveness of the drug treatment.

     In view of the continuous rapid advancement in medical technology and the ever-increasing public expectations, the HA has, since the implementation of the HADF, continued to refine its review mechanism on the HADF through incorporating additional stakeholders into the review process, thereby increasing the transparency of the decision-making process regarding the HADF's coverage. Specifically, in processing applications for new drugs or indications, the HA has consistently maintained close communication with various stakeholders and disseminated relevant information to the stakeholders through multiple channels. For example, prior to meetings of the Drug Advisory Committee, the agenda and list of new drugs under discussion will be sent to patient groups. Following the meetings, the deliberation outcomes (including the primary reasons for not approving particular applications for inclusion in the HADF) will be disseminated for reference. Relevant information will also be uploaded to the HADF's webpage.

     While the HA does not maintain statistics on the time required from the receipt of application to inclusion of drugs in the HADF, to speed up the introduction of suitable new drugs into the HADF, the HA has simplified the application process for inclusion of new drugs in the HADF since the end of 2024. Clinicians and pharmaceutical companies can submit new drug applications directly to the Drug Advisory Committee. The frequency of prioritisation exercise for including new drugs in the safety net will also increase from twice a year to four times a year. With the implementation of the above new mechanisms, the HA has been actively optimising the procedures for introducing new drugs into the HADF, with the objective of reducing the time required for introducing new drugs with proven efficacy into the HADF or the coverage of the safety net by half, from the original 10 months to five months; and from 18 months to nine months respectively, so as to enable patients to have access to new drugs as soon as possible, and to obtain the subsidies under the safety net to alleviate the burden of drug expenses. Furthermore, the HA will establish the Office for Introducing Innovative Drugs and Medical Devices in the first half of 2026 which will proactively engage with relevant pharmaceutical companies on the Mainland and other regions so as to facilitate the registration of innovative drugs in Hong Kong and their inclusion in the HADF.

     The HA will continue to pay close attention to the latest scientific research and clinical evidence of drugs suitable for treatment of various diseases, with a view to ensuring that patients are provided with cost-effective drugs of proven safety and efficacy as well as continuous optimal care.

(4) For drugs which cover multiple indications, the accumulation of clinical evidence for each indication is influenced by various factors. As a result, the evidence regarding the safety, efficacy, and cost-effectiveness of the same drug may vary across different indications. As aforementioned, the review process of the HADF is evidence-based. Given that the efficacy and cost-effectiveness of the same drug may vary across different diseases, the HA evaluates applications for inclusion of each new drug and indication into the HADF from perspectives such as evidence-based medicine practice, equitable and effective use of public resources, targeted subsidisation, and opportunity cost. This ensures that healthcare resources are focused on treatments that have been proven effective through rigorous research.

(5) The HKSAR Government has been following the principles of complementarity and mutual benefits to enhance healthcare-related co-operation with various Mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA), on the premise of benefitting the development of the healthcare systems of Hong Kong and the Mainland, so as to provide convenience to Hong Kong residents who choose to develop and reside on the Mainland. In particular, the Government supports the healthcare needs of these Hong Kong residents through collaboration with suitable healthcare organisations in the Mainland cities in the GBA. Examples include the Elderly Health Care Voucher Greater Bay Area Pilot Scheme, the Pilot Scheme for Supporting Patients of the Hospital Authority in the GBA, as well as the proposed new function under the five-year plan of eHealth+ to allow members of the public to keep and use their personal medical records from within and outside Hong Kong. 

     The regime for the evaluation, approval, registration and import of pharmaceutical products are different in Hong Kong and the Mainland. In particular, importation of Hong Kong pharmaceutical products is governed under the Import and Export Ordinance (Cap. 60), and thus must be covered by a licence issued by the DH under the authority of the Director-General of Trade and Industry. However, pharmaceutical products imported in the accompanied personal baggage of a person entering Hong Kong for his or her personal use and in reasonable quantity may be exempted from the licensing requirement. However, these products which have not been registered in accordance with the Pharmacy and Poisons Ordinance (Cap. 138) may not meet Hong Kong's requirement for the safety, quality and efficacy of registered pharmaceutical products.

     The HKSAR Government, with the important role of protecting the health of Hong Kong citizens, will continue to provide quality healthcare services to Hong Kong citizens with no intention to shift such responsibility to the Mainland healthcare system. In this connection, the Government has currently no plan to specifically provide support for members of the public to go north to buy drugs.

 (6) Currently, the HADF contains a variety of drugs for treating various diseases, among which most classes of drugs are provided to public hospital patients at a standard fee which is heavily subsidised by the Government. In cases where doctors, based on patients' clinical needs, recommend the use of self-financed drugs which are outside the scope of the highly subsidised service, the patients concerned will be informed of the cost of the prescribed course of drug treatment by the doctors or pharmacy staff so as to facilitate patients' consideration on whether to proceed with the recommended treatment.

     Meanwhile, the vast majority of commonly used drugs in the HA are currently procured through open tendering. To maintain high transparency in procurement information, the HA has consistently published details such as drug tender notices, the names of successful tenderers, contract summaries, total drug quantities and total contract values online for public access. However, given that drug prices are commercially sensitive information, the HA will not disclose the unit price of specific purchased drugs in order to avoid affecting the drug procurement process and the bargaining power of the HA during the process.

Ends/Wednesday, October 22, 2025
Issued at HKT 17:00

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