DH invites representatives from GBA Center for Drug Evaluation and Inspection of National Medical Products Administration to brief local pharmaceutical industry on latest developments in drug regulation and registration evaluation in Chinese Mainland
The Department of Health (DH) today (June 5) invited senior reviewers from the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Center for Drug Evaluation and Inspection of the National Medical Products Administration (NMPA) to attend a forum called "New Chapter in Pharmaceutical Regulation: 2026 Drug Regulation and Review Trends Forum" to provide the local pharmaceutical industry with a detailed overview of the latest developments and relevant regulatory requirements regarding drug regulation and registration evaluation in the Chinese Mainland. The forum aimed to help the local industry seize opportunities to expand into the Mainland market, while fostering drug innovation and collaboration within the GBA.
The forum was co-organised by the Hong Kong Institute of Biotechnology Limited and the HongKong Pharmaceutical Manufacturers Association Limited, with the DH as the supporting organsiation. The forum featured a comprehensive programme, covering key drug regulatory legislation in the ChineseMainland, drug registration procedures and application requirements, as well as quality and specification requirements. It helped local pharmaceutical manufacturers and agents to better understand the preparatory work required for drug registration in theChineseMainland, including the documents and information that need to be submitted.
The forum attracted over 100 representatives from the local pharmaceutical sector, including manufacturers and wholesalers. Participants generally considered that the content was practical and highly valuable. Not only did it provide a clear roadmap and timeline for drug registration in the ChineseMainland, it also significantly reduced the time and effort required for information collection and document preparation.
Prior to the forum, a delegation from the GBA Center for Drug Evaluation and Inspection met with the staff of the DH's Drug Office yesterday (June 4) to exchange views on practical experiences in drug evaluation and inspection in the ChineseMainland. DH staff also briefed the delegation on the initiatives of the Hong Kong Special Administrative Region (HKSAR) Government to develop Hong Kong into an international health and medical innovation hub; enhance the evaluation, approval and registration mechanism for drugs; implement a "primary evaluation" mechanism for new drugs; and prepare for the establishment of the Hong Kong Centre for Medical Products Regulation within this year.
The DH has been actively promoting and enhancing Hong Kong's drug regulatory standards. The NMPA and its GBA Center for Drug Evaluation and Inspection have been providing staunch support for the HKSAR's pharmaceutical regulatory efforts. The DH expressed its sincere gratitude to the delegation. Looking ahead, the DH will continue to deepen cooperation and exchanges with the drug regulatory authorities in the ChineseMainland, support the development of Hong Kong's pharmaceutical industry, and actively align with the National 15th Five-Year Plan to better integrate into and serve overall national development. At the same time, the HKSAR will leverage Hong Kong's distinctive advantages of enjoying strong support of the Motherland and being closely connected to the world, to fulfil its role as a "super connector".
DH invites representatives from GBA Center for Drug Evaluation and Inspection of National Medical Products Administration to brief local pharmaceutical industry on latest developments in drug regulation and registration evaluation in Chinese Mainland Source: HKSAR Government Press Releases
DH invites representatives from GBA Center for Drug Evaluation and Inspection of National Medical Products Administration to brief local pharmaceutical industry on latest developments in drug regulation and registration evaluation in Chinese Mainland Source: HKSAR Government Press Releases
DH invites representatives from GBA Center for Drug Evaluation and Inspection of National Medical Products Administration to brief local pharmaceutical industry on latest developments in drug regulation and registration evaluation in Chinese Mainland Source: HKSAR Government Press Releases
CHP investigates confirmed Mpox case epidemiologically linked to "Hutong"
The Centre for Health Protection (CHP) of the Department of Health (DH) said today (June 5) that it is investigating a confirmed locally acquired Mpox (also known as Monkeypox) case epidemiologically linked to the two cases involving in "Hutong" announced on May 25. The CHP has been closely following up on the investigation, including attempting to contact individuals who visited the premises on or after May 1, providing them with health education and continuing to conduct medical surveillance. The CHP urged the public to be vigilant and avoid close physical contact with persons suspected of contracting Mpox. Meanwhile, high-risk target groups are advised to receive Mpox vaccinations.
Case details
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The case involves a 52-year-old male who reported to have high-risk contact at a premises called "Hutong" on Shanghai Street, Mong Kok, on May 2 (during the incubation period). He developed a non-pruritic and painless rash over his genital area on May 21, followed by a fever and sore throat on May 25, and a subsequent rash eruption over his upper limbs, chest, and anal region. The CHP made several attempts to contact the patient between the end of May and the beginning of June, but had failed to reach him. The CHP thus sent him a text message. The patient attended the Yau Ma Tei Male Social Hygiene Clinic on June 4 to seek medical treatment and reported relevant high-risk contact history to the healthcare workers. The CHP subsequently arranged for him to receive isolation treatment at the Yan Chai Hospital. The patient is currently in stable condition. His samples tested positive for Monkeypox virus upon laboratory testing by the Public Health Laboratory Services Branch of the CHP.
According to the information provided by the patient, he has not received Mpox vaccination. The CHP is continuing its epidemiological investigations of the case and endeavouring to contact individuals who had high-risk contact with him. The CHP will report the case to the World Health Organization.
Follow-up on the "Hutong" cases in Mong Kok
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The CHP continues to follow up on the investigation of the cases in "Hutong", and has now successfully contacted around 300 persons who have visited the premises on or after May 1. No other cases have been identified so far. The CHP has provided them with health education and continued to conduct medical surveillance. The CHP again urges anyone who visited the premises on or after May 1 to call the CHP's designated Mpox telephone hotline (2125 2373), so that the CHP can provide health assessments and advice. The hotline operates daily from 9am to 6pm. As investigations are still ongoing, the premises has been closed temporarily starting from May 26.
Furthermore, the CHP will collaborate with Hong Kong AIDS Foundation to launch an outreach Mpox vaccination activity in the next two weeks at the organisation's service centre in Mong Kok. Eligible high-risk groups (especially men who have sex with men) can make an appointment on the organisation's website.
Since 2022, Hong Kong has recorded a total of 88 Mpox cases (71 local cases and 17 imported cases), including the above-mentioned case. All patients were males. Epidemiological investigations revealed that most cases had history of high-risk sexual behaviour, including having sex with strangers or having sex without wearing condoms.
Mpox vaccine
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Mpox vaccine can prevent infection and severe disease. The DH provides Mpox vaccination services for highrisk groups. The following high-risk target groups are eligible for Mpox vaccinations on a voluntary basis:
individuals with high-risk sexual practices, e.g. having multiple sexual partners, sex workers, or having a history of sexually transmitted infection within the past 12 months;
healthcare workersresponsible forcaring forpatients with confirmed Mpox;
laboratory personnel working with zoonotic pox viruses; and
animal care personnel with high risk of exposure in caseof Mpox occurrences in animals in Hong Kong.
High-risk target groups can receive Mpox walk-in vaccinations at any of the DH's SocHS (namely Chai Wan SocHS, Wan Chai Male SocHS, Wan Chai Female SocHS, Yau Ma Tei Male SocHS, Yau Ma Tei Female SocHS, Yung Fung Shee SocHS, Fanling SocHS and Tuen Mun SocHS) and the DH's Yau Ma Tei Integrated Treatment Centre.
Meanwhile, the DH's Kowloon Bay Integrated Treatment Centre and the Hospital Authority's Special Medical Clinics at Queen Elizabeth Hospital and Princess Margaret Hospital also provide Mpox vaccination services for their clients.
Mpox is not transmitted through respiratory droplets or aerosols in general, and transmission would not occur through social contact. The CHP reminds the public, especially those at higher risks of exposure, to take precautions and avoid close physical contact with persons or animals suspected of infection. They should seek medical attention as soon as possible if they experience relevant symptoms, including rash, fever, chills, swollen lymph nodes, exhaustion, muscle pain, and severe headaches. They should not engage in activities with others that may involve contact with skin rash or body fluids.
For more details, please visit the CHP's page onMpoxandMpox Vaccination Programme.
Source: AI-found images
