LCQ8: Introduction of drugs for use in Hong Kong

     Following is a question by the Hon Joephy Chan and a written reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (December 11):

Question:

     It is learnt that a number of new oncology and cancer drugs from the Mainland have shown satisfactory efficacy, but their introduction into Hong Kong is subject to a complicated drug registration system. On the other hand, there are inadequacies in the Named Patient Program (the Program) introduced by the authorities, such as the need for individual applications to make full pre-payment to pharmaceutical companies, the cumbersome procedures for doctors' applications for drugs and the long lead time from the submission of applications to the granting of approval and the individual packaging and shipment of drugs. In this connection, will the Government inform this Council:

(1) of the following information about the Program in each of the past five years:

(i) the number of applications received;

(ii) the expenditure involved;

(iii) the top 10 drugs with the highest number of applications, the number of applications for and the fees of such drugs, and whether they were provided free of charge for use by patients in public hospitals and private hospitals;

(iv) the average time respectively between the receipt and approval of applications, and between the approval of applications and the use of the drugs; and

(v) how the final charges for the drugs are determined (for example, whether the charges only aim at recovering the cost);

(2) as it is learnt that the certification of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is widely recognised as the most stringent pharmaceutical specification in the world, and there are views that the Government, as a member of PIC/S, may help facilitate the introduction of Mainland-made drugs overseas while the Mainland's application for joining PIC/S is pending approval, of the following in the past five years:

(i) the number of drugs by Mainland pharmaceutical companies which had lodged applications for Good Manufacturing Practice (GMP) for Medicinal Products certification by PIC/S in Hong Kong, and the number of applications involved;

(ii) the number of occasions on which the Department of Health (DH) had to send GMP inspectors to the Mainland and overseas for conducting certification, and the expenditure involved; and

(iii) the average waiting time for GMP certification applications; and

(3) of the details of DH's total staff establishment responsible for handling PIC/S certification at present, and their duties; whether it will introduce express/priority handling arrangements or set up a dedicated team for urgently-needed drugs to expedite the certification and registration of the drugs?

Reply:

President,

     "The Chief Executive's 2024 Policy Address" has proposed a number of initiatives to improve the drug approval mechanism so as to speed up registration and facilitate good drugs for use in Hong Kong. In particular, to enhance the drug regulatory regime, the Hong Kong Special Administrative Region (HKSAR) Government implemented a new mechanism for the approval of new drugs ("1+" mechanism) (Note 1) on November 1, 2023, which has been extended to all new drugs since November 1 this year, including vaccines and advanced therapy products. So far, the Department of Health (DH) has received more than 350 enquiries from over 90 pharmaceutical companies, and approved seven new drugs under the "1+" mechanism, bringing new hope for treatment to patients. The seven new drugs mentioned above include two new drugs for treating metastatic colorectal cancer which have been approved by the National Medical Products Administration and have been listed in the "Special Drug" category of the Hospital Authority (HA) Drug Formulary. Not only has the procurement cost of the drugs been reduced by nearly 30 per cent successful after price negotiation by the HA, patients are also only required to pay the standard fee of $15 if these two drugs are prescribed under specified clinical applications, greatly alleviating their financial burden. It is expected that nearly 300 cancer patients will benefit each year. Extending the "1+" mechanism could 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.

     In consultation with the DH and the HA, the reply to the question raised by the Hon Joephy Chan is as follows: 

(1) Under the Pharmacy and Poisons Regulations (Cap. 138A) (Regulations), pharmaceutical products must satisfy the criteria of safety, efficacy and quality and be registered with the Pharmacy and Poisons Board of Hong Kong (Board) before they can be sold or supplied in Hong Kong. 

     To address the needs of patients for the prevention and treatment of life threatening and severely debilitating diseases (e.g. cancer and rare diseases), the law allows a registered medical practitioner or a registered dentist to possess or use of an unregistered drug for the purpose of treatment of a particular patient for which no registered drugs for effective treatment or prevention are available (Note 2). Importation of unregistered pharmaceutical products under the above situation needs to apply for an import licence from the DH under the authority of the Director-General of Trade and Industry in accordance with the Import and Export Ordinance (Cap. 60) and meeting the approval requirements for the issuance of the import licence. The performance pledge of the Drug Office of the DH in approving applications for import and export licence for pharmaceutical products is two working days. The relevant arrangement is to ensure that a registered medical practitioner or dentist will not be prevented from obtaining and administering a necessary drug to a local patient on the ground that an overseas pharmaceutical company has not applied for registration of the drug in Hong Kong.

     The number of applications for import of unregistered drugs for particular patients (including applications from the HA) received and import licenses issued by the DH in the past five years are set out in the table below. The DH does not regulate or handle commercial transactions between importers and doctors/organisations or between doctors/organisations and patients, and thus, does not maintain information on the fees of relevant drugs. Meanwhile, the HA does not maintain statistics on the use of unregistered drugs for treatment under its Named Patient Scheme (Note 3).
 

Year Number of applications for import of unregistered drugs for the treatment of particular patients received by the DH (Note 5) Number of import licenses issued for import of unregistered drugs for the treatment of particular patients (Note 5) (Note 6)
2019 (Note 4) 6 269
2020 (Note 4) 6 061
2021 (Note 4) 7 101
2022 7 359 7 283
2023 7 268 7 195

Note 4: Before December 31, 2021, the DH adopted a paper-based approach in processing applications for import licenses and did not keep records on the number of applications.

Note 5: Multiple import licences may be applied for the same drug in accordance with the circumstances and conditions.

Note 6: The applicant may only partially or not import the drug concerned after the issue of the import licence. Therefore, the actual number of drugs imported may be smaller.

     The 10 drugs with the highest number of applications for import of unregistered drugs for the particular patients received by the DH between 2022 and 2023 are tabulated below. The DH does not maintain the actual expenditure involved for processing relevant applications.
 

  Drugs with the highest number of applications for import of unregistered drugs for the treatment of particular patients received by the DH Number of applications for import of unregistered drugs for the treatment of particular patients (Note 7)
1 Selpercatinib capsule 80mg (Note 8) 214
2 Mobocertinib 40mg Cap 208
3 INDIUM-111 SOLUTION IN VIALS (Indium (In 111) Oxinate)  178
4 ORALTEK Spray 176
5 SLITone ULTRA Dermatophagoides pteronyssinus + Blomia Maintenance kit 152
6 SLITone ULTRA Dermatophagoides (HDM) mix Maintenance kit 145
7 ATROPINE EYE DROPS 0.01% (Note 8) 138
8 Mon.Tek Mo-99/Tc-99m Generator (Note 8) 129
9 MyoMIBG-I 123 Injection 122
10 FRUQUINTINIB (ELUNATE) CAP. 5MG (Note 8) 121

Note 7: The number of applications made by applicants for different drugs may vary depending on factors such as the nature of the drug and its expiry date. Hence, the number of applications for a drug may not fully reflect the demand for the drug.

Note 8: Relevant drugs have been registered in Hong Kong during 2023 and 2024.

     The HKSAR Government encourages pharmaceutical products manufacturers or suppliers to apply for registration in Hong Kong of unregistered drugs with continued need for use. The DH will continue to proactively publicise the "1+" mechanism and liaise closely with the trade.

(2) and (3) The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organisation comprising pharmaceutical inspection authorities from multiple countries and regions with a mission to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. As of December 2, 2024, there were 56 participating authorities in the PIC/S. Hong Kong has become a member of the PIC/S since 2016. The DH is responsible for GMP inspections to ensure compliance of manufacturers. Hong Kong's membership of the PIC/S signifies that it has been recognised by international drug regulatory bodies and its drug regulatory standards have reached international standards.

     According to the Regulations, all local pharmaceutical products manufacturers must obtain a licence from the Board to manufacture pharmaceutical products. Since the Board has become the participating authority of the PIC/S on January 1, 2016, one of the key requirements for licensing a manufacturer for pharmaceutical products is the full compliance with the PIC/S GMP standards. The relevant standards covered requirements on drug manufacture including the pharmaceutical quality system, personnel, premises, equipment, documentation, production process, quality control, outsourced activities, complaint handling, product recall and self-inspection of manufacturer so as to ensure that high quality drugs were produced. At present, there are 22 licensed local pharmaceutical products manufacturers which they are all fully compliant with the PIC/S GMP standards. 

     At present, the Manufacturers Regulatory Unit (Unit) of the Drug Office of the DH is responsible for processing application of manufacturer licence (including applications for post-licensing changes), examining compliance with the licensing requirements laid down by the Board as well as the level and requirements of the PIC/S GMP, with a view to making a recommendation for approval of the application to the Board. The Drug Office is also responsible for conducting regular and ad hoc inspections on local licensed pharmaceutical manufacturers based on risks associated with their products and the track record of inspections, so as to ensure their continuous compliance with the Code of Practice for Licensed Manufacturers and Registered Authorized Persons released by the Board and the relevant PIC/S GMP requirements. Relevant licensing and inspection work includes meeting with manufacturers to discuss the commissioning or changing plan before processing the application, reviewing the documents and information submitted by the manufacturer including the quality management policies, activities of the site, the production and quality control of pharmaceutical manufacturing operations carried out therein and key personnel, as well as arranging and conducting PIC/S GMP inspections, preparing inspection reports and following up the corrective actions with the manufacturers as necessary. In addition, the Unit is also responsible for the update, amendment and implementation of PIC/S GMP standards, including the adoption of new version of PIC/S GMP Guide to enhance local GMP standards, participation in international exchanges and meetings with other PIC/S participating authorities, assisting in the development of PIC/S related guidelines, and the need to receive regular training related to PIC/S and GMP. The Unit currently comprises a senior pharmacist, pharmacists, and scientific officers. The Unit also handles tasks other than PIC/S GMP inspections, and some tasks related to PIC/S also involve other units. The DH does not maintain the breakdown of the staff establishment responsible for handling PIC/S certification.

     For applications of registration of pharmaceutical products with non-local manufacturers, the applicants for registration of those products should submit evidence of compliance with PIC/S GMPs. Applicants who do not successfully invite other PIC/S participating authorities to conduct inspection may consider inviting the Drug Office of the DH to conduct PIC/S GMP inspection outside Hong Kong by submitting the relevant invitation. After receiving the invitation and taking into account factors like risks arising from the inspection and whether the drug may address local healthcare medical needs, the Unit of the Drug Office will consider arranging PIC/S GMP inspection outside Hong Kong if the following conditions are fulfilled:

(i) The invitation has to be issued by the applicant of registration of pharmaceutical products, together with all the required information and supporting documents related to the manufacturer;
(ii) The concerned manufacturer is not located in country or region that is PIC/S member and the relevant facility has not yet been inspected by other PIC/S participating authority;
(iii) The applicant has to confirm that the drug regulatory authority of the country or region where the manufacturer is located has been informed or has no objection to the PIC/S GMP inspection of the manufacturer by the Drug Office;
(iv) The inspection outside Hong Kong will not affect the Drug Office's schedule for inspections of local manufacturers in Hong Kong; and
(v) The applicant pays the required inspection fees on the full cost-recovery principle.

     Due to the COVID-19 epidemic, the DH has not conducted any PIC/S GMP inspections to manufacturers outside Hong Kong from 2020 to 2022. From 2023 to November 2024, the DH, as invited by applicants of registration, arranged three PIC/S GMP inspections to pharmaceutical manufacturers outside Hong Kong, which were in Jordan, the Philippines and Mainland China respectively.

Note 1: Under the "1+" mechanism, eligible holders of registration from one (instead of two in the past) of the recognised drug regulatory authorities for new drugs could apply for registration in Hong Kong, on the condition that they could provide local clinical data which complies with the requirements and recognised by local experts.

Note 2: Regulation 36(1A) of the Regulation stipulates that the prescribed requirement for registration of pharmaceutical products is not applicable to certain specified circumstances, including the possession or use of the pharmaceutical product for the purpose of treatment by a registered medical practitioner or registered dentist of a particular patient in accordance with Regulation 36(1A)(ab) of the Regulations.

Note 3: If doctors of public hospitals, based on their professional judgement and having regard to the clinical conditions of individual patients, consider that it is necessary to prescribe unregistered drugs, they may submit an application for import license to the DH through the suppliers via the HA Named Patient Scheme. Meanwhile, according to the charging guidelines for the use of drugs not listed in the HA Drug Formulary (including both registered and unregistered drugs), if a hospital or a doctor needs to use a drug not listed in the HA Drug Formulary for treatment for an emergency situation (including immediate life threatening situations, for use as drugs for treating poisoning conditions and for treatment of infectious diseases that give rise to an imminent medical need), the HA will provide the necessary drug to the patient at standard fees. If such drugs are prescribed to meet the specific clinical needs of a particular patient, the patient has to bear the cost of the drugs.




Temporary traffic and transport arrangements on Prince Edward Road East (westbound) from early hours of December 16 to facilitate road works

     The Transport Department (TD) today (December 11) reminded the public that the following temporary traffic and transport arrangements will be implemented on Prince Edward Road East (westbound) from 1.30am to 5.30am daily from December 16 to 20 (next Monday to Friday) to facilitate road works:
 
(A) Road closures
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     The following road sections will be temporarily closed to all vehicular traffic:
 

  • Part of the traffic lanes of Prince Edward Road East (westbound) between Kowloon East Regional Police Headquarters and Trade and Industry Tower;
  • The at-grade section of Prince Edward Road East (westbound) between Trade and Industry Tower and Olympic Garden;
  • Part of the traffic lanes of the slip road leading from Choi Hung Road (southbound) to Prince Edward Road East (westbound);
  • The slip road leading from Concorde Road to Prince Edward Road East (westbound) near Kai Tak Community Hall;
  • The flyover leading from the at-grade section of Prince Edward Road East (westbound) to Ma Tau Chung Road (southbound) near Olympic Garden;
  • The flyover leading from the at-grade section of Prince Edward Road East (westbound) to Argyle Street (westbound); and
  • Part of the fast lane of Prince Edward Road East (eastbound) near Muk Lai Street.

 
(B) Traffic diversions
 ——————-
 

  • Affected vehicles on Prince Edward Road East (westbound) heading for Argyle Street will be diverted via the following routes:
  1. The elevated section of Prince Edward Road East (westbound), Prince Edward Road West (westbound), Stirling Road (southbound), Argyle Street (eastbound), roundabout on Argyle Street and Argyle Street (westbound); or
  2. Roundabout on Concorde Road, Olympic Avenue (westbound), Sung Wong Toi Road (eastbound), Sung Wong Toi Road (westbound), Ma Tau Chung Road (eastbound), roundabout on Argyle Street and Argyle Street (westbound).

 

  • Affected vehicles on Prince Edward Road East (westbound) heading for Ma Tau Chung Road will be diverted via the following routes:
  1. The elevated section of Prince Edward Road East (westbound), Prince Edward Road West (westbound), Stirling Road (southbound), Argyle Street (eastbound), roundabout on Argyle Street and Ma Tau Chung Road (westbound); or
  2. Roundabout on Concorde Road, Olympic Avenue (westbound), Sung Wong Toi Road (eastbound), Sung Wong Toi Road (westbound), Ma Tau Chung Road (eastbound), roundabout on Argyle Street and Ma Tau Chung Road (westbound).

 
(C) Public transport arrangements
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     To facilitate road works, Citybus route No. N23 (Tung Chung bound), cross-harbour bus route No. N121 (Central bound), KMB route Nos. N216 (Hung Hom bound), N293 (Mong Kok bound) and 293S (Mei Foo bound), and Hong Kong Island green minibus overnight route No. 61 (Mong Kok bound) will be diverted and some of the stops will be suspended or relocated. Please visit the TD's website for details (www.td.gov.hk/en/traffic_notices/index_id_78424.html).
 
(D) Suspension of metered parking spaces
—————————————-
 
     Two metered parking spaces (Nos. 8259A and 8259B) on Stirling Road will be temporarily suspended.
     
     Appropriate traffic signs and road markings will be erected on site to guide motorists. The public transport operators will display notices informing passengers of the above temporary arrangements. The TD anticipates that the travelling time at the road sections concerned will be slightly lengthened due to the diversion arrangements. Motorists should exercise tolerance and patience.
     
     Members of the public are advised to plan their journeys in advance and allow sufficient travelling time to cater for unexpected delays, and stay alert to the latest traffic news through the media or the TD's mobile application "HKeMobility" or website (www.td.gov.hk).




Employee sentenced to imprisonment and fined for violation of safety legislation

     An employee was sentenced to two months' imprisonment and fined $2,500 at the West Kowloon Magistrates' Courts today (December 11) for violating the Factories and Industrial Undertakings Ordinance and the Construction Sites (Safety) Regulations. The prosecutions were launched by the Labour Department (LD).
      
     The case involved a fatal accident that occurred on December 22, 2021, at a drainage work site in Chek Lap Kok. While conducting maintenance on an inspection chamber, a team of four workers and a foreman (namely the convicted employee) inhaled toxic gas successively. Two workers died, while the other two workers and the foreman were injured.
      
     The LD's spokesman said, "The LD welcomes the court's decision and believes the aforementioned sentences have a deterrent effect to remind employees to strictly comply with the requirements under safety legislation to safeguard the safety and health at work of himself and of other persons."




Hong Kong Customs detects three dangerous drugs cases and seizes suspected drugs worth about $15 million (with photos)

     Hong Kong Customs detected three dangerous drugs cases in Tsuen Wan, Yuen Long; Yau Tong; and Hong Kong International Airport yesterday (December 10), and seized about 15 kilograms of suspected ketamine, 32.5kg of suspected cannabis buds, 2kg of gummy candies containing suspected tetrahydro-cannabinol (THC) and 234 vape sticks containing suspected THC, with a total estimated market value of about $15 million. Three persons suspected to be connected with the cases were arrested.

     In the first case, during an anti-narcotics operation conducted in the vicinity of Tsuen Wan yesterday morning, Customs intercepted a 30-year-old man and found about 350 grams of suspected cannabis buds and 30 vape sticks containing suspected THC inside a paper bag and rucksack carried by him. He was then arrested. Customs officers then escorted the man to an industrial unit nearby for a search and found about 6.6kg of suspected cannabis buds, 2kg of gummy candies containing suspected THC and 204 vape sticks containing suspected THC and a batch of drug packaging paraphernalia therein. Upon a follow-up investigation, the man was brought to a village house rented by him in Yuen Long for a search, and about 20.5kg of suspected cannabis buds were uncovered. About 27.5kg of suspected cannabis buds, 2kg of gummy candies containing suspected THC and 234 vape sticks containing suspected THC in total were seized in the operation.

     In the second case, through in-depth investigations and data analyses, Customs yesterday searched a mini-storage warehouse in Yau Tong. Upon searching, a total of about 5kg of suspected cannabis buds were found concealed in some pet food packages inside a batch of carton boxes. Afterwards, Customs arrested a 37-year-old man in Ngau Chi Wan suspected to be connected with the case.

     The third case involved a 31-year-old man who arrived in Hong Kong from Frankfurt, Germany, yesterday. During Customs clearance, Customs officers found 15kg of suspected ketamine wrapped by clothes in his check-in suitcase. He was subsequently arrested.

     The arrestee in the first case was charged with three counts of trafficking in a dangerous drug and will appear at the West Kowloon Magistrates' Courts tomorrow (December 12). The arrested man in the second case has been released on bail pending further investigation. An investigation of the third case is ongoing.

     Customs reminds members of the public that cannabis and THC are classified as dangerous drugs under the Dangerous Drugs Ordinance. Importation of products (including food or drinks) containing cannabis or THC into Hong Kong is prohibited unless the relevant provisions in the Ordinance are complied with. In order to avoid breaching the law inadvertently, special attention should be paid to the packaging labels of those products.

     Under the Ordinance, trafficking in a dangerous drug is a serious offence. The maximum penalty upon conviction is a fine of $5 million and life imprisonment.

     Members of the public may report any suspected drug trafficking activities to Customs' 24-hour hotline 182 8080 or its dedicated crime-reporting email account (crimereport@customs.gov.hk) or online form (eform.cefs.gov.hk/form/ced002).

Photo  Photo  Photo  



November’s monthly gravidtrap index for Aedes albopictus mosquitoes drops from October level

     The Food and Environmental Hygiene Department (FEHD) today (December 11) announced that the monthly gravidtrap index for Aedes albopictus mosquitoes in November dropped to 0.6 per cent from 2 per cent in October, which remained at the lowest Level 1, indicating that the distribution of Aedes albopictus mosquitoes in the areas surveyed was not extensive.

     In November, all the 64 survey areas were recorded with a gravidtrap index lower than the alert level of 20 per cent. Moreover, the monthly density index for Aedes albopictus in November was 1.1, which represented that an average of 1.1 Aedes albopictus adults were found in the Aedes-positive gravidtraps, indicating that the number of adult Aedes albopictus was not abundant in the survey areas. The gravidtrap and density indices for Aedes albopictus in different survey areas as well as information on mosquito prevention and control measures are available on the department website at www.fehd.gov.hk.

     A spokesman for the FEHD said, "In response to the latest recorded local case of dengue fever (DF), the FEHD and relevant government departments have intensified mosquito prevention and control work in the residence, workplace and locations visited by a patient during the incubation period and after illness onset, including eliminating mosquito breeding places, applying larvicides, conducting fogging operations to eradicate adult mosquitoes, and placing mosquito trapping devices at suitable locations. The FEHD has also provided government departments with professional advice and technical support to assist them in swiftly formulating and implementing effective anti-mosquito measures while strengthening publicity and education at the same time, in order to reduce the risk of DF transmission. Under the concerted efforts and collaboration of various parties, the index in November remained at the lowest level. The FEHD will continue to monitor the mosquito infestation in all districts, and will conduct prompt and effective mosquito prevention and control work."

     The FEHD has conducted a three-phase Anti-mosquito Campaign this year. The third phase of the territory-wide campaign, lasting 12 weeks, was conducted from August 5 to October 27. During the period, the district offices of the FEHD targeted areas that had drawn particular concern, such as public markets, cooked food centres and hawker bazaars, single-block buildings, streets and back lanes, common parts of buildings, village houses, construction sites, vacant sites and road works sites, to remove accumulated water and carry out mosquito prevention and control work. To further enhance the effectiveness of mosquito control, the FEHD and relevant government departments have carried out the second phase of the All-out Anti-mosquito Operations since May 2 to focus on intense adult mosquito control by means of regular ultra-low volume fogging operations to continue to eliminate potential mosquito breeding places, and called on property management offices to arrange necessary repairs to their premises to minimise mosquito breeding places. As the weather has turned cooler and drier, the All-out Anti-mosquito Operations launched since March 26 this year will end on December 30. Although the index remains at a low level, the breeding and activity of mosquitoes will not stop in winter. The FEHD advises members of the public to continue routine mosquito prevention and control work to reduce the chance of mosquito breeding when the rainy season approaches. 

     The FEHD appeals to members of the public to continue to stay alert and work together to carry out mosquito prevention and control measures early, including inspecting their homes and surroundings to remove potential breeding grounds, changing water in vases and scrubbing their inner surfaces, removing water in saucers under potted plants at least once a week, properly disposing of containers such as soft drink cans and lunch boxes, and drilling large holes in unused tyres. The FEHD also advises members of the public and estate management bodies to keep drains free of blockage and level all defective ground surfaces to prevent the accumulation of water. They should also scrub all drains and surface sewers with an alkaline detergent at least once a week to remove any mosquito eggs.

     â€‹Aedes albopictus is a kind of mosquito that can transmit DF. DF is commonly found in tropical and subtropical regions of the world, and has become endemic in many countries in Southeast Asia. Based on the latest surveillance data from the Centre for Health Protection of the Department of Health, there has been an increase in DF cases in some places in Asia thus far, compared with the corresponding period of last year. The World Health Organization has recorded over 13 million cases, which is a record number, since the beginning of 2024. Although the number of DF cases recorded in Guangdong Province in the past few months remained at a high level, and most of the cases were locally acquired infection, the number of local DF cases has been decreasing gradually, from over 1 200 cases a week (November 4 to 10) to around 500 cases a week (November 18 to 24), according to the Guangdong Provincial Center for Disease Control and Prevention. Hong Kong has recorded 152 imported DF cases and five local DF cases so far this year. Members of the public should continue to carry out effective mosquito prevention and control measures proactively.