LCQ5: Industrial accidents involving lifting appliances

Source: Hong Kong Government special administrative region – 4

     Following is a question by the Hon Lam Chun-sing and a reply by the Secretary for Labour and Welfare, Mr Chris Sun, in the Legislative Council today (April 1):
 
Question:
 
     It has been reported that so far this year, there have been three fatal industrial accidents relating to lifting operations in the construction industry, including the collapse of a tower crane (commonly known as a sky crane) at a construction site in Kwai Chung on the 19th of last month, which resulted in the death of a worker. In this connection, will the Government inform this Council:
 
(1) of the number of prosecutions instituted by the Government in each of the past two years and so far this year against owners of lifting appliances or lifting gear for contravening the Factories and Industrial Undertakings (Lifting Appliances and Lifting Gear) Regulations, and the number of successful convictions among such cases and the average amount of fines imposed; 

(2) as Hong Kong has recorded two serious fatal incidents involving the collapse of sky cranes at construction sites in less than four years, whether the Government will comprehensively review and enhance the inspection and regulatory mechanisms to ensure the structural and operational safety of sky cranes, so as to prevent the recurrence of similar incidents; if so, of the details; if not, the reasons for that; and 

(3) whether it will consider requiring that personnel engaged as “slingers” and “signallers” in lifting appliances operations must undergo professional training and possess recognised qualifications; if so, of the details and the implementation timetable; if not, the reasons for that? 

Reply:
 
President,

     The Government is highly concerned about an accident that happened at a construction site in Kwai Chung on March 19 this year, in which a tower crane collapsed suddenly during its operation. The Government is saddened by the death of the crane operator and expresses its deepest sympathy to his family. 
 
     The Labour Department (LD) is conducting the investigation at full speed to identify the cause of the accident, ascertain the liability of the duty holders and recommend improvement measures. The LD will take strict actions pursuant to the law if any breach of legislation is identified during the investigation.
 
     Our reply to the question raised by the Hon Lam Chun-sing is as follows:

(1) The LD initiated 388 and 281 prosecutions against owners of lifting appliances or lifting gear for breaches of the Factories and Industrial Undertakings (Lifting Appliances and Lifting Gear) Regulations in 2024 and 2025 respectively. As at February this year, a total of 28 prosecutions have been initiated. The numbers of convicted summonses and the average fines for the same period are set out in Annex.

(2) The Government attaches great importance to workers’ occupational safety and health (OSH). The construction industry has the highest number of fatal industrial accidents and the highest accident rate per 1 000 workers. The LD pays particular attention to the safety level of the construction industry and the changes in the OSH risk of construction workers. Pursuant to the risk-based principle, the LD formulates and adjusts relevant strategies on the inspection and enforcement, education and training as well as technology application, etc, to enhance the effectiveness.

     As far as inspection and enforcement are concerned, territory-wide special inspection exercises have been launched from March 30 (Monday), targeting construction sites involving tower crane lifting operations. The LD is also making use of technologies to enhance the enforcement efficiency of frontline officers, including the use of small unmanned aircraft for aerial photography and videography to remotely monitor tower crane operations, and assist frontline officers in inspecting the high‑up positions of tower cranes that are normally difficult to reach, thereby curbing unsafe lifting operations and strengthening the monitoring of the structural safety of tower cranes.

     Besides, the LD will continue to conduct special enforcement operations on the construction sites using lifting appliances, including the erection, inspection, and lifting operations of tower cranes, and will also carry out comprehensive and in‑depth surprise inspections on the construction sites involving unsafe lifting operation or poor safety performance. If breaches of the requirements under the OSH legislation, including the use of unsafe machinery in workplace, are identified during inspection, actions will be taken pursuant to the law.

     The “Code of Practice for Safe Use of Tower Cranes” (CoP) has been issued by the LD on the safe and correct use of tower cranes, providing practical guidance on the safe use and operation of tower cranes to ensure the safety of personnel working on and near the cranes. The LD is revising the said CoP, the main revisions of which include enhancing the requirements and inspections for tower crane installation, welding processes, anchorages and foundations safety.  The industry will also be required to install video devices and install and use the Tower Crane Alert System. Inspection checklist templates for inspection, testing and thorough examination of tower cranes will also be included in the CoP for reference by relevant inspection personnel so as to further enhance the safety level of tower crane operations.

     On the other hand, the LD is working with the Development Bureau and the Building Technology Research Institute to provide advice on the relevant OSH legislation for the newly developed Remote-Control Tower Crane System. This remote-control system enables tower crane operators to operate the crane in a cabin on the ground, and identify safety risks with the use of artificial intelligence technology, thereby enhancing lifting safety and improving the working environment for crane operators.

(3) The existing CoP of the LD provides practical guidance on the safe and correct use of tower cranes, specifying the requirements for riggers and signallers as well as the knowledge required for their duties. 

     The LD, in revising the CoP, will consider enhancing the safety training requirements for riggers and signallers, e.g. requiring them to hold a valid certificate of the Safety Training Course for Construction Workers (Silver Card Course) – Rigger and Signaller issued by the Hong Kong Institute of Construction before they are allowed to perform the related work.  

     The LD strives to publish the newly revised CoP within this year to further enhance the safety level of tower cranes. In the subsequent inspections at the construction sites equipped with tower cranes, the LD will pay particular attention to whether the relevant riggers and signallers meet the training and technical requirements set out in the new CoP.

Membership lists of “the three committees” announced

Source: Hong Kong Government special administrative region – 4

​The Government announced today (April 1) that the Secretary for Home and Youth Affairs had respectively appointed 1 918 persons, 553 persons and 530 persons as members of the Area Committees, the District Fight Crime Committees and the District Fire Safety Committees (collectively referred to as “the three committees”) for a new term of office of two years starting from April 1, 2026.

The Government identifies suitable persons who aspire to serve the community via various channels to join “the three committees” on the basis of the merit of the individuals concerned, taking into account various factors, including a candidate’s ability, expertise, experience, integrity, commitment to serving the community, as well as with due regard to the functions of “the three committees”.

The membership lists of “the three committees” in 18 districts have been uploaded to the Home Affairs Department’s website (www.had.gov.hk/en/18_districts/my_map.htm).

President Lai meets delegation from European Parliament Committee on Security and Defence

Source: Republic of China Taiwan

President Lai meets delegation from European Parliament Committee on Security and Defence
On the morning of March 31, President Lai Ching-te met with a delegation from the European Parliament’s Committee on Security and Defence (SEDE). In remarks, President Lai thanked the European Parliament for its longstanding, staunch support for Taiwan. He emphasized that in the face of growing authoritarian expansion, Taiwan understands the need to steadily bolster its self-defense capabilities, overall societal resilience, and collaboration with like-minded partners, as only through strength can peace and stability in the region be ensured. President Lai expressed hope that Taiwan and the European Union will continue expanding cooperation in key strategic industries and join hands to safeguard our cherished universal values such as democracy, freedom, and respect for human rights.
I would first like to warmly welcome our esteemed guests from the European Parliament. This is the first official delegation from the SEDE to visit Taiwan since it was upgraded to a full standing committee last year, making your trip all the more meaningful. I thank you all for the great importance you attach to Taiwan and for your support.
I also wish to extend appreciation to the European Parliament for its strong backing of Taiwan. In January, resolutions on the annual implementation reports for the EU Common Foreign and Security Policy and Common Security and Defence Policy were adopted. They reaffirmed the EU’s opposition to China’s distortion of United Nations General Assembly Resolution 2758 and to the use of force or coercion to unilaterally change the status quo in the Taiwan Strait. Moreover, the European Parliament supports the continued deepening of Taiwan-EU cooperation and exchanges across various domains. This demonstrates the EU’s commitment to upholding democratic values and underscores that Taiwan is one of its key partners in the Indo-Pacific.
In the face of growing authoritarian expansion, Taiwan understands the need to steadily bolster our self-defense capabilities, overall societal resilience, and collaboration with like-minded partners. Only through strength can we ensure peace and stability in the region. Therefore, in recent years, Taiwan has actively advanced the domestic development of aircraft, naval vessels, and unmanned vehicles. The government has also proposed a US$40 billion special defense budget spanning eight years. It aims to boost national defense and build more resilient defense systems. Defense spending, as it is defined by NATO, will be 3.32 percent of GDP this year, and we expect it to reach 5 percent of GDP by 2030.
After my inauguration, I established the Whole-of-Society Defense Resilience Committee under the Presidential Office. Integrating the strengths of the central government, local governments, and the private sector, it aims to comprehensively expand Taiwan’s risk management and crisis response capabilities. By strengthening civilian force training, strategic material preparation, the healthcare system, and critical infrastructure, Taiwan is creating a solid foundation of societal resilience for national security.
Taiwan has long stood on the frontline against authoritarian expansion and hybrid threats. We are glad to share the experience we have gained with the EU and other friends and allies in the international community. By joining hands, we can safeguard regional peace and the democratic way of life we hold dear. Looking ahead, I hope that with the support of our guests here today and the European Parliament, Taiwan and the EU will be able to form mechanisms for even closer cooperation in key strategic industries including drones, semiconductors, cybersecurity, and aerospace. Together, we can create safe, trusted, and resilient democratic supply chains to maintain the security and autonomy of key sectors.
I would like to emphasize that democratic cooperation is not about opposing anyone else, but rather about protecting our cherished universal values such as democracy, freedom, and respect for human rights. In closing, I would like to once again thank our guests for visiting Taiwan at a time of such intense geopolitical shifts, expressing their support through concrete action. I hope that this visit will further deepen mutual understanding and trust between Taiwan and the EU and lay an even more solid foundation for future collaboration. I wish you all a pleasant and productive stay.
SEDE Chair Marie-Agnes Strack-Zimmermann then delivered remarks, stating that although the members of the delegation come from different member states and political groups, they are united in a common purpose, which is to deepen their understanding, listen carefully, and strengthen their cooperation with Taiwan. She continued on to say that their visit has particular importance for them, as it is the first mission of the SEDE to Taiwan since it became a full standing committee, and that it takes place at a very serious moment. Europe is waking up to new security realities, she said, first triggered by Russia’s illegal war of aggression against Ukraine. In addition, she continued, war in the Middle East is now drawing much of the international community’s attention, and there is also growing instability in the broader strategic environment, with many asking whether this could create new risks for Taiwan.
Chair Strack-Zimmermann stated that for this reason, it is important for Europe to be present, attentive, and clear. From Russia to the Middle East and the Indo-Pacific, she said, war and threats of war make it difficult not to see the situation as one increasingly unstable security complex. The chair continued on to say that the delegation is here because Taiwan matters to Europe, and that Taiwan matters as a democracy, as an economic and technological partner, and as an important actor in the global trading system. Taiwan also matters because peace and stability in the Taiwan Strait are directly relevant not only for this region, but also for European security and prosperity, she said.
The chair indicated that Europe is also going through an important change; in response to Russia’s war against Ukraine, it is strengthening its approach to security and defense. She noted that Europe is investing more, is thinking more seriously about preparedness and resilience, and is paying closer attention to the protection of critical technologies and supply chains, and that in this respect, Europe and Taiwan face different situations but understand and are affected by many of the same challenges. She then stated that their message is clear and balanced: They support stability, support dialogue, and oppose coercion and any unilateral change to the status quo by force, while also remaining committed to a responsible and pragmatic European approach.
Chair Strack-Zimmermann said that they also believe cooperation between Europe and Taiwan should continue to grow in practical ways, including areas such as secure supply chains, semiconductors, cybersecurity, critical infrastructure, and defense industrial resilience. These are not only economic issues, she said, but also security issues. She closed her remarks by saying that the delegation has come with a genuine wish to deepen practical cooperation with Taiwan.
The delegation also included Members of the European Parliament (MEPs) Nicolás Pascual De La Parte of the European People’s Party, Vice-chair of the Delegation for Relations with the Countries of Central America José Cepeda, and Vice-chair of the Committee on Foreign Affairs Urmas Paet, as well as MEPs Mārtiņš Staķis andNikolas Farantouris. They were accompanied to the Presidential Office by Head of the European Economic and Trade Office Lutz Güllner. 

Outdoor seating process streamlined

Source: Hong Kong Information Services

Starting today, the Food & Environmental Hygiene Department (FEHD) will collaborate with relevant departments to implement a new joint-vetting mechanism to streamline the procedures for processing applications for outside seating accommodation (OSA) of restaurants.

Previously, the median processing time for OSA applications was 12 months from receipt of an application to approval.

Under the new arrangements which aim to facilitate business operations, applicants of simple and straightforward cases can expect to get an approval in principle within about one month, with information of detailed licensing requirements.

In addition, application requirements have also been suitably relaxed, e.g. eligible restaurants will not be required to increase food room areas and sanitary fitments for the OSA.

Also, applications involving walkways with a remaining width of three metres or more after the OSA provision, will generally be considered meeting the traffic requirements.

Each relevant department will also assign a dedicated case manager to handle applicants’ enquiries.

Under the new arrangements, the application form has been enhanced to ensure that each department involved receives necessary information upfront, therefore expediting the approval process.

District Offices will conduct local consultations in parallel. If no objections are raised, applications will be approved in principle. Formal approval will be granted once applicants comply with licensing requirements, and inspections are completed by the FEHD and other departments.

For complex cases arising during the joint-vetting, the relevant Permanent Secretaries and even the Deputy Chief Secretary will step in to resolve issues.

After the approval of OSA, the departments will conduct audit checking as necessary to ensure that there are no violations.

The Chief Executive announced in the 2025 Policy Address that the FEHD and relevant departments would expedite OSA applications of restaurants and streamline procedures.

The trade has been briefed on the new arrangements. Click here for details and application forms.

Income allowance limits adjusted

Source: Hong Kong Information Services

The Government today announced adjusted income and asset limits for the Working Family Allowance (WFA) Scheme, effective from this month.

The new limits will apply to all claim months from April 2026 to March 2027.

While income limits for households with six or more persons will remain at the 2025-26 level, those for five-person households will be aligned with four-person household limits.

Limits for other household sizes will be increased according to the established mechanism.

The Government explained that under the mechanism, and based on 2025 data, income limits for households with six or more persons would typically be tightened, while the limit for five-person households would be lower than those for four-person households. A number of existing WFA households would thus become ineligible for, or receive less, WFA.

Meanwhile, asset limits for all household sizes will be increased according to the same mechanism.

Additionally, if the Appropriation Bill 2026 is passed by the Legislative Council, the Government will, as proposed in the 2026-27 Budget, disburse a one-off extra allowance to WFA households.

It expects to distribute the one-off grant a month after the bill’s passage at the earliest.

The WFA scheme aims to support lower-income working families that are not on Comprehensive Social Security Assistance.

Call 2558 3000 for details.

Fermeture temporaire de la RT3 au niveau de Houaïlou – Manutention et évacuation d’un camion au PR21+900 (Perlou)

Source: Gouvernement de la Nouvelle-Caledonie

Le gouvernement, via sa direction des Infrastructures, de la topographie et des transports (DITTT), informe les usagers de la RT3 qu’un incident impliquant un camion de béton, actuellement bloqué dans la rivière de Perlou au PR21+900 de la RT3 (Houaïlou), nécessite une intervention spécifique.

À ce titre, la circulation sera interrompue demain jeudi 2 avril 2026 à partir de 8 heures.

Cette fermeture est rendue nécessaire par les opérations de manutention et d’évacuation du véhicule, mobilisant notamment une grue de fort gabarit sur la chaussée, ainsi que plusieurs équipes d’intervention. Ces opérations se dérouleront avec le concours de la gendarmerie.

La durée prévisionnelle de l’intervention est estimée à trois heures, hors aléas indépendants de la volonté des intervenants. La réouverture de la circulation interviendra dès la fin des opérations, sans préavis.

La DITTT s’excuse pour la gêne occasionnée durant cette opération et remercie les usagers pour leur compréhension.

Elle rappelle l’importance de respecter la signalisation temporaire mise en place ainsi que les limitations de vitesse aux abords du chantier, afin de garantir la sécurité de tous, usagers comme intervenants.

La sécurité est l’affaire de tous.

Simplification administrative : le gouvernement lance une consultation des acteurs économiques

Source: Gouvernement de la Nouvelle-Caledonie

Le gouvernement de la Nouvelle-Calédonie fait de la simplification des démarches administratives et de la réduction des normes inutiles une priorité majeure de son action en faveur du développement économique.

Aujourd’hui, le temps consacré par les entrepreneurs à des tâches administratives éloignées de leur coeur de métier constitue un frein direct à leur activité et plus largement à la croissance du pays. Face à ce constat, le gouvernement a engagé une première série de réformes structurantes.

Une loi du pays portant des mesures importantes de simplification est actuellement soumise au Congrès de la Nouvelle-Calédonie. Elle prévoit notamment la création d’un registre unique des entreprises, dispositif central destiné à simplifier concrètement les démarches des acteurs économiques.
Dans cette dynamique, le gouvernement souhaite aller plus loin en préparant un deuxième volet de réformes, construit au plus près des réalités du terrain.
Afin d’associer pleinement les acteurs économiques à cette démarche, une consultation en ligne est lancée pour recueillir leurs retours d’expérience et identifier les démarches à simplifier en priorité.

Les contributions des entreprises, des organisations professionnelles et de l’ensemble des acteurs concernés sont essentielles pour élaborer des mesures concrètes, efficaces et adaptées aux besoins du tissu économique calédonien.

Le gouvernement appelle l’ensemble des organisations représentatives à relayer largement cette consultation afin de garantir une participation la plus large possible.

Cette démarche s’inscrit dans une volonté claire : simplifier durablement l’environnement des entreprises pour libérer l’activité, favoriser l’emploi et soutenir la croissance de la Nouvelle-Calédonie.

2026 Hong Kong Family and Women Development Summit held

Source: Hong Kong Government special administrative region – 4

The 2026 Hong Kong Family and Women Development Summit, jointly organised by the Home and Youth Affairs Bureau (HYAB), the Women’s Commission and the Family Council, was held today (March 31). Marking the 30th anniversary of the adoption of the Beijing Declaration and Platform for Action at the United Nations Fourth World Conference on Women, and building on the spirit of the Global Leaders’ Meeting on Women held in Beijing in October 2025, this Summit adopted the theme “Shaping Women’s Strengths and Harnessing a Shared Future for Families”, aiming to take women’s development and family building to the next level. The Summit attracted more than 1 200 representatives from local and Guangdong-Hong Kong-Macao Greater Bay Area women’s groups, the business sector and relevant service organisations to register and participate.

State Councilor, Chairperson of the National Working Committee on Children and Women under the State Council and President of the All-China Women’s Federation (ACWF), Ms Shen Yiqin, officiated at the Summit and delivered an opening address.

The Chief Executive, Mr John Lee, said in his remarks at the opening ceremony that the Global Leaders’ Meeting on Women was successfully convened in Beijing last year, injecting new momentum into promoting global gender equality and the all-round development of women. President Xi Jinping put forward four proposals in the meeting – jointly foster an enabling environment for women’s growth and development, jointly cultivate powerful momentum for the high-quality development of women’s causes, jointly develop governance frameworks to protect women’s rights and interests, and jointly write a new chapter in promoting global co-operation on women. These important proposals provide clear direction for the development of women’s causes, inspiring broader consensus-building and taking more pragmatic actions to fully promote the all-round development of women.

Mr Lee said his policy rationale is to build Hong Kong into a caring and inclusive home, with the family at its core. Women’s development and family building complement each other. The current-term Government has actively implemented various measures to lay a solid foundation in these two aspects. Looking ahead, the Government will continue to improve support policies for women in areas such as employment and entrepreneurship, lifelong learning, and physical and mental well-being to sustain an environment conducive to women’s development. Concurrently, further efforts will be made to promote the importance of family, family education and family values, and to advocate Chinese traditional virtues, thus fostering a caring and inclusive community.

The Summit gathered leaders responsible for family and women’s policies from the nation and Hong Kong, representatives of international organisations and prominent figures from related fields as speakers. They included the Secretary-General of the International Organization for Mediation, Professor Teresa Cheng; Head of Office (ad interim) of UN Women China, Mr Chuqiao Wang; the Secretary for Home and Youth Affairs, Miss Alice Mak; and the Chairperson of the Women’s Commission, Dr Eliza Chan. In their keynote speeches, they shared their experience and insights on women’s development in the new era, the promotion of women’s rights and interests, and family building.

Miss Mak said in her keynote speech, “This year’s Summit adopted the theme ‘Shaping Women’s Strengths and Harnessing a Shared Future for Families,’ encompassing society’s collective responsibility and commitment, while echoing the core spirit of the Beijing Meeting. Through this Summit, we hope to carry forward the vision of the Beijing Meeting and implement the important proposals put forward by President Xi, so that women can see opportunities, receive support and participate in development, while families can be filled with warmth, harmony and love, and play an important role in social governance.”

Miss Mak said that since taking office in 2022, the current-term Government has entrusted the HYAB with the important responsibility of promoting women’s development. Under the leadership of the Chief Executive, the HYAB has implemented a number of measures to promote women’s and family development, including continuously promoting awareness of gender equality and gender mainstreaming in the community, encouraging enterprises to adopt family-friendly measures, launching the Family and Women Portal, and supporting women of different backgrounds and ages to better equip themselves through the Women Empowerment Fund (the Fund) and the “She Inspires” Mentorship Programme (the Programme), thereby injecting stronger impetus into women’s development in Hong Kong. The annual allocation for the Fund has been increased from $20 million to $30 million, while the quota for the second cohort of the Programme has also been increased to 120. The HYAB and the Family Council have also launched the five-year new Funding Scheme on the Promotion of Family Education to subsidise community family education projects to raise public awareness of the importance of family values. Last year, the Hong Kong Special Administrative Region Government launched the first Hong Kong Excellent Family Awards to promote family education and family virtues by sharing families’ real-life stories.

Two thematic sessions were held at the Summit. The first session themed “Co-creating ‘She Power’ in the New Era” was chaired by the Deputy Secretary for Home and Youth Affairs (Home Affairs), Mr Paul Wong. The panelists, including Representative of the United Nations Population Fund to China, Ms Nadia Rasheed; Vice-Chairperson and the Secretary-General of China Women’s Development Foundation, Ms Dong Kui; and the Chief Executive Officer of the MTR Corporation, Ms Jeny Yeung, shared their experiences and explored ways to foster an enabling environment for women’s development, and empower them to seize the opportunities of the new era.

The other session with the theme “Uniting Our Families, Co-building a Harmonious Society” was co-chaired by the Chairperson of the Family Council, Ms Melissa Pang, and the emcee of the Summit, Ms Astrid Chan. Renowned artistes Mr and Mrs Moses Chan; Olympic diving champion and member of the World Aquatics Diving Technical Committee, Ms Guo Jingjing; and two recipients of the Hong Kong Excellent Family Awards, Lai Yan-hon’s family and Lee Yuk-yee’s family, shared their experiences in fulfilling family responsibilities and wisdom in managing their households. They also discussed how family cohesion provides steadfast support in times of adversity, and how this strength can spread warmth to the wider community and help build a harmonious society.

Exhibition booths were also set up at the venue to showcase the achievements of women’s groups and family service organisations in promoting women’s development and family education.

For details and highlights of the Summit, please visit the webpage of the Hong Kong Family and Women Development Summit (www.familyandwomensummit.hk/hyab2026/home).

                 

“Primary evaluation” begins phased implementation and applications of new drugs for registration accepted under initial phase

Source: Hong Kong Government special administrative region

“Primary evaluation” begins phased implementation and applications of new drugs for registration accepted under initial phase      
     As mentioned in “The Chief Executive’s 2025 Policy Address” that the Hong Kong Special Administrative Region (HKSAR) Government would establish the Hong Kong Centre for Medical Products Regulation (CMPR) in 2026 and begin the phased implementation of the “primary evaluation” mechanism for new drug registration in the same year. The HKSAR Government aims to achieve full coverage of all pharmaceutical products by 2030, which will enable Hong Kong to independently assess and approve the safety and efficacy of new drugs based on clinical data, with a view to expediting the introduction of innovative medical products, thereby achieving the goal of making good drugs and medical devices available for use in Hong Kong for the benefit of patients.
      
     To pave the way for “primary evaluation”, the Government first implemented the “1+” drug approval mechanism on November 1, 2023, to facilitate the registration of new drugs in Hong Kong for treating life-threatening or severely debilitating diseases. The mechanism was extended on November 1 the following year to cover all new drugs, including all new chemical or biological entities, new indications, vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can be applied for registration in Hong Kong if the applicant submits evidence of approval from the drug regulatory authority of one non-local reference place (instead of two in the past). Since the launch of the “1+” mechanism, 19 new drugs have been approved under this mechanism. Seven of them have been listed in the Hospital Authority Drug Formulary. This brings new treatment options for patients and attracts more drug research and development (R&D) as well as clinical trials to be conducted in Hong Kong. 
      
     “Primary evaluation” is a new and comprehensive regulatory process to approve applications for registration of new drugs which involves the independent assessment of primary data of all pre-clinical trials (i.e. animal testing), clinical studies, pharmacovigilance, manufacturing and quality control, etc in order to fully ensure their safety, efficacy and quality before and after the drugs are placed in the market (i.e. throughout the product life cycle). Registering new drugs under the “primary evaluation” mechanism facilitates immediate approval without relying and waiting for approval from non-local drug regulatory authorities, which further speeds up the introduction of new drugs and clinical applications. This will not only help speed up patients’ access to breakthrough treatments but also boost medical R&D, testing and related industries in Hong Kong. The Office for Introducing Innovative Drugs and Medical Devices under the Hospital Authority will, after ascertaining the needs and benefits of innovative drug treatments for local patients, proactively liaise with manufacturers of innovative drugs and medical devices, and utilise the “1+” mechanism for registration to bring in innovative drugs and medical devices that are beneficial and cost-effective for patients.
      
     For details of applications for the registration and the briefing seminars, please visit the DH’s dedicated websiteIssued at HKT 19:39

NNNN