Hong Kong Expands 1+ Drug Approval Mechanism to All New Drugs Starting November 2024

Extending the "1+" mechanism to all new drugs on November 1

The Department of Health (DH) today (October 25) said that according to measures announced in "The Chief Executive's 2024 Policy Address", the "1+" mechanism will extend to all new drugs, including vaccines and advanced therapy products, on November 1, 2024, facilitating good drugs for use in Hong Kong.Extending the "1+" mechanism will attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards "primary evaluation". The Government will complement technological innovation with institutional innovation, developing Hong Kong into an international health and medical innovation hub.

Under the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must satisfy the criteria of safety, efficacy and quality and be registered with the Pharmacy and Poisons Board of Hong Kong before they can be sold or supplied in Hong Kong.According to the "1+" mechanism that came into effect on November 1 last year, new drugs used for the treatment of life-threatening or severely debilitating diseases that are supported by local clinical data and whose scope of application is recognised by local relevant experts are required to submit approval from one reference drug regulatory authority (instead of two in the past) for application for registration in Hong Kong. The "1+" mechanism will be extended on November 1, applicable to applications for registration of all new drugs.

The DH has announced on its relevant website the arrangement for extending the "1+" mechanism to all new drugs and issued letters to notify relevant stakeholders (including relevant pharmaceutical associations and holders of certificates of drug registration) about the extension measure and relevant details of the "1+" mechanism. For further details, please refer to the Drug Office's website. The DH will also introduce consultation service for new drug applications under the "1+" mechanism in the first quarter of 2025 to enhance efficiency in processing relevant applications.

Since the implementation of the "1+" mechanism, the DH has received more than 260 enquiries from over 80 pharmaceutical companies, including those from overseas and the Mainland. A total of five new drugs have been approved under this mechanism. These included two new drugs for treating metastatic colorectal cancer, one for treating paroxysmal nocturnal haemoglobinuria, and two new drugs for treating hypercalcaemia in patients with parathyroid carcinoma and in certain patients with primary hyperparathyroidism, bringing new hope for treatment to patients.

The first two new drugs approved under the "1+" mechanism for treating metastatic colorectal cancer have been listed under the category of "Special Drug" on the Hospital Authority (HA) Drug Formulary. Patients prescribed these two drugs under specified clinical applications are only required to pay standard fees and charges, which are substantially subsidised, greatly alleviating their financial burden. The HA will encourage drug manufacturers or suppliers to apply for local registration of unregistered drugs with ongoing needs and continue to liaise closely with the DH regarding the "1+" mechanism.

The Policy Address also announced other measures to expedite the reform of the approval mechanism of drugs. These include putting forward a timetable for establishing the Hong Kong Centre for Medical Products Regulation and charting a roadmap towards "primary evaluation" in the first half of 2025, as well as formulating strategies and measures to facilitate research and development of medical products.

Fourth cohort of School Nominations Direct Admission Scheme opens for applications in October

The Education Bureau (EDB) today (October 25) announced that the fourth cohort of the School Nominations Direct Admission Scheme (SNDAS) will be open for applications by local Secondary Six students who will be taking the 2025 Hong Kong Diploma of Secondary Education (HKDSE) Examination and commencing their undergraduate studies in September 2025.

A spokesman for the EDB said, "Launched in the 2022/23 academic year, the SNDAS is a scheme that recognises the exceptional talents of students in specific disciplines that may not be fully assessed by the HKDSE Examination by allowing students with special and diversified talents to be matched with programmes that suit their potential. It provides opportunities for these students to be considered for direct admission to local universities."

The nomination period of the fourth cohort of the SNDAS will run from October 25 to December 4, 2024. Students who intend to apply for their preferred programmes through the SNDAS must be nominated by their secondary schools. Each local secondary school can nominate two students with exceptional talents and interests in specific disciplines/areas, and each student nominee can apply for admission to one designated University Grants Committee (UGC)-funded undergraduate programme participating in the SNDAS.

Participating universities will arrange interviews for all students nominated for the SNDAS and make firm offers to successful students prior to the release of the 2025 HKDSE Examination results.

The eight UGC-funded universities have designated around 300 publicly funded undergraduate programmes to participate in the fourth cohort of the SNDAS and set admission criteria that are not based on HKDSE Examination results for individual programmes. Details of the SNDAS and specific admission requirements of the participating programmes have been uploaded to the scheme's website (www.edb.gov.hk/en/edu-system/postsecondary/policy-doc/SNDAS/index.html).

The EDB adds that the SNDAS was introduced to provide an additional pathway to university for students with exceptional talents. Those nominated for the SNDAS, like other Secondary Six students, are required to apply for admission to universities through the Joint University Programmes Admissions System in parallel and to sit for the HKDSE Examinations, ensuring they do not limit their opportunities for further studies.

Starting from this 2025/26 academic year, the Home and Youth Affairs Bureau will introduce a new scholarship scheme for successful SNDAS admittees with remarkable achievements in arts, sports and/or community service. Among the students formally admitted to their respective universities under the SNDAS, each of the eight UGC-funded universities will be invited to nominate SNDAS admittees demonstrating outstanding performance in arts, sports and/or community service for the award of scholarships, in addition to the firm offers made. The quotas for nominations and scholarships will be distributed proportionally, taking into account the number of students admitted to each university through the SNDAS. Each awardee, who will not be subject to means testing, will be granted a scholarship of $10,000 per year throughout their four-year tuition period.

The EDB set up the Task Force on Review of School Curriculum in November 2017 to holistically review the primary and secondary curricula. The review report submitted by the Task Force to the EDB in September 2020 put forward six directional recommendations, including the implementation of a new direct admission scheme to enhance flexibility in university admissions. The EDB accepted the recommendation and introduced the SNDAS starting with the 2022/23 academic year.