Hong Kong's Health Department Launches Workshop to Streamline New Drug Application Process and Enhance Efficiency.

DH organises workshop for new drug applications under "1+" mechanism

​The Department of Health (DH) today (June 16) organised the first workshop to provide guidance and share good practices and real-life experiences on submitting applications under the "1+" mechanism with the pharmaceutical industry and relevant stakeholders. The DH aims to work with the pharmaceutical industry to achieve the goals of early consultation to enhance quality and efficiency throughout the process so that registration approval can be expedited, thereby bringing more good drugs for use in Hong Kong.

"The Chief Executive's 2024 Policy Address" announced that a consultation service for new drug applications (NDAs) under the "1+" mechanism would be introduced to enhance the efficiency in processing relevant applications. The consultation service comprises three components, including briefing seminars, workshops and pre-NDA meetings. The first workshop held today attracted over 90 participants from local pharmaceutical and consultancy companies.

Additionally, since March of this year, the DH has organised four briefing seminars to brief the trade and stakeholders on the basic requirements and procedures for Hong Kong drug registration under the "1+" mechanism. These seminars have attracted approximately 200 representatives from pharmaceutical companies, consultancy firms and research institutes, etc, in and outside of Hong Kong. The response from the trade was very positive and the DH will continue to organise workshops and briefing seminars from time to time. The next briefing seminar is scheduled for August 12 and online registrationis open. The materials of the briefing seminar have been uploaded to the thematic webpage on the "1+" mechanism for the trade's reference.

As for one-on-one pre-NDA meetings with potential applicants under the "1+" mechanism, the DH will launch them in the fourth quarter of this year as planned. As the trade gains a better understanding of the application process through the briefing seminars and workshops, the pre-NDA meetings will greatly improve the quality of the application documents and hence the processing efficiency. Details of the arrangements of the pre-NDA meetings will be announced in due course.

The Hong Kong Special Administrative Region Government implemented the "1+" mechanism on November 1, 2023, and has extended it to all new drugs from November 1, 2024, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. Under the "1+" mechanism, new drugs which are supported by local clinical data and recognised by local relevant experts can be applied for registration in Hong Kong by submitting approval from the drug regulatory authority of one of the reference places (instead of two in the past).

The "1+" mechanism serves to 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". Since its implementation, registration of a total of 11 new drugs has been approved under this mechanism. These included five new drugs (including two drugs for treating colorectal cancer, one for treating paroxysmal nocturnal hemoglobinuria, and two for treating secondary hyperparathyroidism and certain hypercalcaemia) that have already been approved for listing on the Hospital Authority Drug Formulary, facilitating more good drugs for use in Hong Kong.

Meanwhile, the Government will expedite the reform of the approval mechanism for drugs and medical devices, including announcing the timetable for establishing the Hong Kong Centre for Medical Products Regulation and a roadmap towards "primary evaluation" very soon, aiming to spur the growth of new industries in pharmaceutical and medical device research and development and testing.

DH organises workshop for new drug applications under "1+" mechanism Source: HKSAR Government Press Releases

DH organises workshop for new drug applications under "1+" mechanism Source: HKSAR Government Press Releases

Public hospitals experience smooth operations on second day of public healthcare fees and charges reform

The following is issued on behalf of the Hospital Authority:

On the second day (January 2) of the implementation of the Hospital Authority public healthcare fees and charges reform (fees and charges reform), public hospitals maintained smooth operation. The HA will continue to deploy additional manpower across various departments at hospitals to assist patients in need.

On the first day (January 1) of the fees and charges reform, 3 888 patients attended the Accident and Emergency departments (A&E) of 18 public hospitals, a decrease of about 25 per cent when comparing to New Year's Day last year. From midnight to 2pm yesterday (January 2), 2 329 patients attended all A&E, approximately 30 per cent fewer than the same time period of January 2 of last year. Among the patients seeking medical consultation, there were 34 critical cases and 82 emergency cases. According to the new fees and charges arrangement, these two categories of patients will have their A&E charges fully exempted. The other cases subject to the new fees and charges arrangement include 986 urgent cases, 1 171 semi-urgent cases, and 56 non-urgent cases. The average waiting times for semi-urgent and non-urgent cases was around 55 minutes, which is shorter compared to the average waiting time for the same period last year (approximately 147 minutes) for semi-urgent and non-urgent cases.

Additionally, the HA's 75 Family Medicine Clinics (FMCs) providing family medicine outpatient services also operated smoothly yesterday. As of 2pm yesterday, approximately 10 000 patients attended these FMCs, with overall service usage remaining similar to that before the implementation of the measures.

The HA has deployed additional manpower to expedite the processing of patients' medical fee waivers applications. As of 2pm yesterday, public hospitals received approximately 3 300 applications in total for the day, with nearly 90per cent approved, amounting to about 2 900 applications. The remaining cases will be processed as soon as possible. Compared to the 14 000 individuals who were approved for medical fee waivers in 2023/24, the HA has approved approximately 35 000 applications since early November last year, benefiting citizens in need.

Furthermore, patients who had previously scheduled non-urgent radiology services or pathology services will be receiving payment notifications through mail or the HA mobile application HA Go starting from January 1. The HA reminds patients with recent appointments can arrange payment as early as practicable upon receiving the notification. For patients with distant appointment dates, payment can be arranged at their convenience after receiving the notification. Patients are not required to settle the payment immediately. Patients undergoing non-urgent radiology services must settle the payment at least 14 days before their appointment date, while patients requiring pathology services must settle the payment before testing. If patients have questions regarding payment items, they can inquire with healthcare staff during follow-up appointment, and specialist out-patient clinics will also have Integrated Patient Service Centres to provide detailed explanations about payment arrangements.

The HA reminds patients that the fees and charges reform has been implemented. Patients are advised to familiarise themselves with the new fees and charges arrangements before visiting public hospitals or outpatient clinics. Some medical service procedures have also been modified. Every cluster has set up hotlines (see table below) for patients to inquire about the fees and charges reform arrangements. Patients can also visit the HA website to learn about the new arrangements.

Hotlines for Public Healthcare Fees and Charges Reform

Clusters

Hotlines

Hong Kong East Cluster

6460 4303

Hong Kong West Cluster

2255 4177

Kowloon Central Cluster

3506 7198

Kowloon East Cluster

5215 7326

Kowloon West Cluster

3467 7575

New Territories East Cluster

6273 3551

New Territories West Cluster

2468 5353

Service hours: January 2-11, 2026, 8am to 8pm

Source: AI-found images