Hong Kong – New “1+” mechanism expedites approval of new drugs
New “1+” mechanism expedites approval of new drugs
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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.
CE: New co-operation mechanism between HK and Chongqing enables development of both places to reach new heights (with photos/videos)
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Mr Lee and the delegation first visited the Jinfeng Laboratory in the morning, to learn about the laboratory’s innovation achievements in biotechnology and medicine aspects. They then visited the International Logistics Hub in Inland China Exhibition Centre in Chongqing to learn more about the development of the city’s logistics infrastructure.
At noon, Mr Lee visited the Ciqikou Ancient Town, a local cultural and tourism landmark, and watched cultural performances. Together with the Secretary of the CPC Chongqing Municipal Committee, Mr Yuan Jiajun, Mr Lee toured around the historic district to experience local culture.
Adjustment mechanism of remuneration of CE and PAOs
*************************************************** The spokesman said, “To show that the governing team is fighting the disease and riding out the difficult times with the public, the CE and all PAOs announced in February 2020 that they would donate one month’s remuneration to the Community Chest of Hong Kong for charity purposes. The CE further announced on April 8, 2020 that she and the Chief Secretary for Administration, the Financial Secretary, the Secretary for Justice, 13 Directors of Bureaux and the Director of the CE’s Office would take a 10 per cent pay cut for the coming 12 months to show togetherness with the people.” “Subsequently, the CE announced on June 9 of the same year that the remuneration of the CE and all PAOs would not increase in accordance with the Consumer Price Index (C) under the established mechanism, in order to show solidarity with the community to tide over the difficult times.” The spokesman explained that the estimated expenditure for the salaries of the CE, the Secretaries of Departments, the Directors of Bureaux and the Director of the CE’s Office in 2021-22 is slightly higher than the revised estimates in 2020-21 because the voluntary pay cut of 10 per cent will end by the end of this June and that the estimated expenditure for the remaining nine months (i.e. July 2021 to March 2022) is calculated based on the level excluding pay cut factor. The remuneration of the CE and PAOs has all along been adjusted according to the established mechanism. The mechanism is in accordance with the recommendations of the Independent Commission on Remuneration Package and Post-office Arrangements for the Chief Executive of the HKSAR, and the Independent Commission on Remuneration for Members of the Executive Council and the Legislature, and Officials under the Political Appointment System of the Hong Kong Special Administrative Region in 2005 and 2016 respectively, and was approved by the Legislative Council Finance Committee (LegCo FC) in the respective years of 2005 and 2017.
Hong Kong – CE: New co-operation mechanism between HK and Chongqing enables development of both places to reach new heights (with photos/videos)
The Chief Executive, Mr John Lee, continued his visit in Chongqing today (May 11). He led a delegation of the Hong Kong Special Administrative Region (HKSAR) Government to visit technology research and logistics facilities, meet with leaders of Chongqing, and attend the High-Level Meeting cum First Plenary Session of the Hong Kong/Chongqing Co-operation Conference, witnessing the first new co-operation mechanism established with Mainland provinces and municipalities since the current term of the HKSAR Government took office.
In the afternoon, the delegation of the HKSAR Government led by Mr Lee and the delegation of the Chongqing Municipal People’s Government led by Mr Yuan, held the High-Level Meeting cum First Plenary Session of the Hong Kong/Chongqing Co-operation Conference.
Mr Lee said that Hong Kong and Chongqing have maintained very close ties and the HKSAR Government established the Chongqing Liaison Unit as early as 2012 to actively promote exchanges between the two places on various fronts. He expressed his hope that Hong Kong and Chongqing can strengthen co-operation in such areas as the Belt and Road Initiative, cultural exchanges and youth development, with a view to better grasping the development opportunities brought about by the National 14th Five-Year Plan, and jointly developing for mutual benefits.
The newly established Hong Kong/Chongqing co-operation conference mechanism is the first new co-operation mechanism set up with provinces and municipalities on the Mainland since the current-term HKSAR Government took office. It is also the third co-operation conference mechanism established by the HKSAR Government with Mainland municipalities directly under the Central Government, following Beijing and Shanghai. Mr Lee said he hopes that Hong Kong and Chongqing can achieve complementarity, enabling the development of both places to reach new heights and further promoting Hong Kong’s proactive integration into the overall national development.
At the plenary, Mr Lee and Mr Yuan jointly witnessed the signing of an agreement on the “Hong Kong/Chongqing Co-operation Conference Mechanism”; the “Co-operation Memorandum of the High-Level Meeting cum First Plenary Session of the Hong Kong/Chongqing Co-operation Conference”; the “Strategic Co-operation Memorandum between Chongqing Municipal Commission of Commerce and Hong Kong Trade Development Council”; as well as the “Co-operation Memorandum on Innovation and Technology between Hong Kong and Chongqing” by Chongqing and Hong Kong.
After the plenary, Mr Lee and the HKSAR Government delegation attended a dinner hosted by Mr Yuan and the Mayor of Chongqing, Mr Hu Henghua.
The Chief Secretary for Administration, Mr Chan Kwok-ki; the Secretary for Commerce and Economic Development, Mr Algernon Yau; the Secretary for Innovation, Technology and Industry, Professor Sun Dong; and the Under Secretary for Constitutional and Mainland Affairs, Mr Clement Woo, also attended the plenary and participated in the visit.
Mr Lee will return to Hong Kong tomorrow (May 12).
Hong Kong – Adjustment mechanism of remuneration of CE and PAOs
A Government spokesman expresses regret over a newspaper report today (May 19) alleging that the politically appointed officials (PAOs) would receive a pay rise this year, saying that the report is misleading and deliberately distorts the adjustment mechanism of the remuneration of the Chief Executive (CE) and PAOs in order to attack the officials of the Hong Kong Special Administrative Region (HKSAR) Government. Ads
