Tag Archives: China

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New “1+” mechanism expedites approval of new drugs

     The Government announced today (December 8) that for the first time, two new drugs for treating cancer were approved for registration in Hong Kong yesterday (December 7) after review under the new mechanism for registration of New Drugs (“1+” mechanism). They are oral targeted drugs in different dosages for treating metastatic colorectal cancer, bringing new hope for treatment to patients for whom conventional chemotherapy has been ineffective or inapplicable.

     A Government spokesman said that the approval of new drugs for registration in just one month or so after the “1+” mechanism came into effect enabled the earlier use of effective new drugs in treating serious or rare diseases. This demonstrated the effective operation of the new “1+” mechanism and the realisation of the policy objective of “good drugs for Hong Kong”. In addition to the important mission of life saving, the “1+” mechanism strengthens local capacity in drug evaluation, marking an important milestone for Hong Kong in the progressive development into an internationally recognised regulatory authority for drugs and medical devices and an international health and medical innovation hub.

     The “1+” mechanism announced in “The Chief Executive’s 2023 Policy Address” came into effect on November 1. Under the “1+” mechanism, applications for registration of new drugs beneficial for treatment of life-threatening or severely debilitating diseases that are supported with local clinical data are only required to submit approval from one reference drug regulatory authority (instead of two originally). The new drugs can register in Hong Kong after the applications are assessed by local experts and approved by the Pharmacy and Poisons Board of Hong Kong.

     Since the commencement of the “1+” mechanism, the Department of Health (DH) has received enquiries from nearly 50 pharmaceutical companies and two new drug applications submitted under the above mechanism. Having the registration approval from the reference drug regulatory authority and the local clinical data submitted by the applicant considered and the Expert Group on Drug Registration consulted, the Board considered that the two new drugs satisfied the criteria of safety, efficacy and quality. The Board has officially approved the registration of the relevant new drugs at a meeting held yesterday afternoon. The DH will notify the applicant of the results of their applications. Details of the registered products will be uploaded to the website of the Board. The two new drugs secured approval for registration for use within a month or so after the “1+” mechanism came into effect.

     The “1+” mechanism facilitates the registration of worldwide new drugs that can meet the local unmet medical needs for life-threatening or severely debilitating disease in Hong Kong. These new drugs can also benefit patients in the Mainland cities of Guangdong-Hong Kong-Macao Greater Bay Area (GBA) under the measure of using Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals in the GBA. Furthermore, the new mechanism can attract more research and development, and clinical trials in relation to drugs to be conducted in Hong Kong. The requirements of local clinical data and recognition by relevant experts for application for registration (the “+” under the “1+” mechanism) will ensure fulfilment of the stringent requirements of safety, efficacy and quality by all pharmaceutical products approved for registration. It will also strengthen the local capacity of drug evaluation and enhance the development of relevant software, hardware and expertise, thereby contributing to the establishment of a drug registration regime based on the “primary evaluation” approach in Hong Kong and recognised by the Mainland and internationally in the long run. read more

Speech by CE at Hong Kong Academy of Medicine Pearl Jubilee Gala Dinner (English only) (with photos/video)

     Following is the speech by the Chief Executive, Mr John Lee, at the Hong Kong Academy of Medicine Pearl Jubilee Gala Dinner today (December 8):

Honourable Vice-Minister Yu Xuejun (Vice-Minister of the National Health Commission), Professor Gilberto Leung (President of the Hong Kong Academy of Medicine), Dr Chow Yu-fat (Chairman of the 30th Anniversary Celebration Organising Committee), distinguished guests, ladies and gentlemen,

     Good evening. I am pleased to join you all this evening, in celebrating the pearl jubilee of the Hong Kong Academy of Medicine.

     Over the years, Hong Kong has established a robust healthcare system that is both credible and efficient. We are among the places with the longest life expectancy in the world.

     At last count, we have over 19 000 registered doctors and dentists in Hong Kong, and over 8 500 of them, or 44 per cent, are specialists.

     From combatting the epidemic and other diseases, to promoting the general health of our people, Hong Kong’s doctors and dentists are the gatekeepers of our community. You protect the health of everyone living in Hong Kong, our home. Ladies and gentlemen, please join me in giving a big round of applause to our medical professionals!

     Medical practitioners are guardians of our health. It is important that they keep abreast of the latest developments in medicine.

     The Hong Kong Academy of Medicine, in the past three decades, has been playing a leading role in upholding the professional competence of our doctors and dentists. Through specialist training curriculum and CPD programmes, the Academy facilitates our practitioners’ delivery of the best care possible for patients. 

     On this occasion, I would like to extend my gratitude to the Academy, for your support over the years. From manpower planning and training of specialists, to uplifting the overall professional qualities of our healthcare services, your contribution is essential to the success of our healthcare system.

     Under the auspices of the “one country, two systems” principle, Hong Kong is the only city in the world that enjoys both the China advantage and the global advantage. Hong Kong boasts five universities in the world’s top 100. Our two medical schools are among the top three in Asia, and in the world’s top 40.

     Alongside our distinguished medical research and education institutions, we have a large pool of multilingual, efficient and dedicated medical professionals. 

     We are uniquely positioned to access international expertise, capital and markets, like no other cities or economies. The National 14th Five-Year Plan supports Hong Kong’s development into an international I&T centre. For the local healthcare sector, this presents an unprecedented opportunity. Now more than ever, we must seize the opportunity to make our mark as a leading health and medical innovation hub in the region.

     That is also why I announced in my second Policy Address that we are working to establish a Hong Kong-based drug approval authority. To do that, we need more global medical enterprises to come and invest in Hong Kong. Our multi-talented, multilingual medical and healthcare professionals – Hong Kong’s golden brand of professionals – would naturally make a good appeal to these enterprises.

     I have full confidence that the Academy of Medicine, with 30 years of experience and expertise in training our world-class professionals, will continue to contribute in shaping our brand within the Guangdong-Hong Kong-Macao Greater Bay Area, on the Mainland and around the globe.

     Indeed, the setting up of the Shenzhen-Hong Kong Medical Specialist Training Centre, through the Academy’s collaboration with Mainland health authorities, helps to nurture medical talent in Shenzhen, the Greater Bay Area and the entire country.

     Ladies and gentlemen, as Hippocrates has said, and I quote, “Wherever the art of medicine is loved, there is also a love of humanity”. Hong Kong is proud to have a world-class medical sector. We will do all we can to support your important work in safeguarding the health of our community.

     My warmest congratulations again on the Academy’s pearl jubilee. I wish you all an enjoyable evening, and a healthy year ahead. Thank you.

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Director of Audit led delegation to attend 7th Guangdong-Hong Kong-Macao Audit Conference 2023 (with photos)

     The Director of Audit, Professor Nelson Lam, led a delegation of Audit Commission officers to Zhuhai to attend the 7th Guangdong-Hong Kong-Macao Audit Conference 2023 held December 6 to 8 for an exchange of experiences in big data auditing with representatives of auditing departments from participating regions and cities. 

     Themed “A study on the implementation and development trend of big data auditing under the empowerment of technology”, the conference was attended by more than 130 representatives from official auditing departments of Guangdong, Hong Kong and Macao. Deputy Secretary of the Communist Party of China Zhuhai Municipal Committee and the Mayor of the Zhuhai Municipal Government, Mr Huang Zhihao; the Secretary of the Leading Party Members’ Group and Director of the Audit Office of Guangdong Province, Mr Ma Xuebin; Professor Lam; and the Commissioner of Audit of the Macao Special Administrative Region, Mr Ho Veng-on, graced the opening ceremony with their speeches.

     In his speech, Professor Lam mentioned that the Hong Kong Government has been actively promoting the development of a smart city and digital economy, so as to proactively integrate into the overall development of the country. The Audit Commission of Hong Kong has been striving to foster research-based and big data auditing. He hoped that through this conference, the Audit Commission of Hong Kong might have in-depth exchanges with counterparts in the auditing sector of Guangdong and Macao, with whom the Audit Commission might join hands to formulate promising plans for “powerful and technology-based auditing” and enable more in-depth, comprehensive and precise auditing work. With concerted efforts, the public auditing sector could actively exercise its “all-encompassing” surveillance power, so as to fully implement the spirit of the 20th National Congress of the Communist Party of China. It would be the auditing sector’s collective goal to follow the three instructions of President Xi on public auditing – “to function under the nation’s directions as the arm moving the finger, to cover issues closely as the shadow following the body, and to make powerful statements as thunder piercing the ears”.

     During the conference, representatives of the auditing departments from the three areas shared their local experiences and practices in big data auditing and had in-depth exchanges of views and insights. The Audit Commission submitted a discussion paper on the application of big data technology in auditing in the context of Hong Kong, with the writing guided by the remarks of President Xi on big data work. The paper was awarded a special prize in the writing event of the 7th Guangdong-Hong Kong-Macao Audit Conference 2023. In addition, a representative from the Audit Commission also took part in the 2023 Guangdong-Hong Kong-Macao Greater Bay Area big data auditing skills competition with nature and environment protection as the topic of choice, and demonstrated the application of data visualisation technology in analysing the efficiency of marine water quality improvement. He won an outstanding award for his demonstration.  

     During the trip, the delegations of Hong Kong and Macao also visited the Xiangzhou District and the High-Tech Industrial Development Zone in Zhuhai, where local officials briefed them on the latest developments of the districts.   

     Professor Lam said that as the first Guangdong-Hong Kong-Macao Audit Conference that resumed after the epidemic, this year’s conference had once again united the auditing profession of the three areas. It had served as an important and valuable platform for exchanges, from which the Audit Commission of Hong Kong had gained understandings on the latest developments in big data auditing. In line with policies of the Central Government, the Audit Commission of Hong Kong would continue its efforts to promote the innovative collaboration and integrated development of the auditing sector of Guangdong, Hong Kong and Macao.

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