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

CHP announces one new melioidosis case

The Centre for Health Protection (CHP) of the Department of Health today (January 16) announced that one new melioidosis case was recorded in the past week (January 9 to 15). The CHP appealed to members of the public to maintain personal and environmental hygiene to prevent melioidosis. The CHP also specifically reminded high-risk groups, including the elderly and people with underlying diseases, to avoid contact with soil or muddy water after typhoons or storms with a view to lowering infection risk.

The case involves a 58-year-old male with underlying illnesses living in Kwai Tsing District. He presented with a fever and vomiting since January 10, followed by confusion on the next day (January 11). He was then sent to the Accident and Emergency Department of Yan Chai Hospital and is currently in the intensive care unit in critical condition. The clinical diagnosis was pneumonia. His clinical sample was confirmed to be positive for Burkholderia pseudomallei upon testing.

The CHP is investigating the infection source of the case. Initial epidemiological investigations revealed that the case is sporadic. No epidemiological linkages have been established between this case and other confirmed cases previously recorded in Hong Kong.

As of yesterday (January 15), one melioidosis case has been recorded in Hong Kong this year. In 2025, 21 melioidosis cases were recorded.

Person-to-person transmission and animal-to-human transmission are rare, but the bacteria causing melioidosis can survive in the local environment. Melioidosis is an endemic disease in Hong Kong, and melioidosis cases have been recorded in Hong Kong each year.

According to literature, melioidosis cases are more common after typhoons or rainstorms. The bacterium Burkholderia pseudomallei in soil and muddy water may become exposed to the ground after typhoons or rainstorms, and the bacteria could spread more easily with strong winds or rainstorms. As such, the number of melioidosis cases may increase.

With this in mind, where practicable, members of the public should stay indoors during typhoons and rainstorms, avoid travelling to areas with potential flooding, and not wade in or have contact with muddy water and soil. In addition, high-risk individuals should avoid paths near stormwater drains where aerosols may be generated from contaminated water.

Members of the public should also take the following preventive measures against infection:

Avoid contact with contaminated soil;

Wear appropriate protective clothing or footwear when participating in activities with possible contact with soil or water, e.g. using gloves and wearing boots. High-risk individuals may also consider wearing a surgical mask;

Wash or shower after exposure to contaminated water or soil;

Always clean any wounds as soon as possible and cover them with waterproof dressings;

Wash hands with liquid soap and water after handling soil or gardening;

Observe food hygiene and avoid drinking raw water; and

Travellers can contract the disease through outdoor water sports. Risk of infection can be minimised by avoiding exposure to water sources (such as rivers, ponds or lakes) that might be contaminated.

The CHP appealed to members of the public to seek medical advice if they develop symptoms, in particular people with diabetes or other immunocompromising conditions, in order to receive an appropriate medical diagnosis and treatment. For more information on melioidosis, please visit the website of the CHP atwww.chp.gov.hk/en/healthtopics/content/24/101110.html.

Source: AI-found images