DH organises workshop for new drug applications under "1+" mechanism
The Department of Health (DH) today (June 16) organised the first workshop to provide guidance and share good practices and real-life experiences on submitting applications under the "1+" mechanism with the pharmaceutical industry and relevant stakeholders. The DH aims to work with the pharmaceutical industry to achieve the goals of early consultation to enhance quality and efficiency throughout the process so that registration approval can be expedited, thereby bringing more good drugs for use in Hong Kong.
"The Chief Executive's 2024 Policy Address" announced that a consultation service for new drug applications (NDAs) under the "1+" mechanism would be introduced to enhance the efficiency in processing relevant applications. The consultation service comprises three components, including briefing seminars, workshops and pre-NDA meetings. The first workshop held today attracted over 90 participants from local pharmaceutical and consultancy companies.
Additionally, since March of this year, the DH has organised four briefing seminars to brief the trade and stakeholders on the basic requirements and procedures for Hong Kong drug registration under the "1+" mechanism. These seminars have attracted approximately 200 representatives from pharmaceutical companies, consultancy firms and research institutes, etc, in and outside of Hong Kong. The response from the trade was very positive and the DH will continue to organise workshops and briefing seminars from time to time. The next briefing seminar is scheduled for August 12 and online registrationis open. The materials of the briefing seminar have been uploaded to the thematic webpage on the "1+" mechanism for the trade's reference.
As for one-on-one pre-NDA meetings with potential applicants under the "1+" mechanism, the DH will launch them in the fourth quarter of this year as planned. As the trade gains a better understanding of the application process through the briefing seminars and workshops, the pre-NDA meetings will greatly improve the quality of the application documents and hence the processing efficiency. Details of the arrangements of the pre-NDA meetings will be announced in due course.
The Hong Kong Special Administrative Region Government implemented the "1+" mechanism on November 1, 2023, and has extended it to all new drugs from November 1, 2024, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. Under the "1+" mechanism, new drugs which are supported by local clinical data and recognised by local relevant experts can be applied for registration in Hong Kong by submitting approval from the drug regulatory authority of one of the reference places (instead of two in the past).
The "1+" mechanism serves to 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". Since its implementation, registration of a total of 11 new drugs has been approved under this mechanism. These included five new drugs (including two drugs for treating colorectal cancer, one for treating paroxysmal nocturnal hemoglobinuria, and two for treating secondary hyperparathyroidism and certain hypercalcaemia) that have already been approved for listing on the Hospital Authority Drug Formulary, facilitating more good drugs for use in Hong Kong.
Meanwhile, the Government will expedite the reform of the approval mechanism for drugs and medical devices, including announcing the timetable for establishing the Hong Kong Centre for Medical Products Regulation and a roadmap towards "primary evaluation" very soon, aiming to spur the growth of new industries in pharmaceutical and medical device research and development and testing.
DH organises workshop for new drug applications under "1+" mechanism Source: HKSAR Government Press Releases
DH organises workshop for new drug applications under "1+" mechanism Source: HKSAR Government Press Releases
SITI visits Guangxi
The Secretary for Innovation, Technology and Industry, Professor Sun Dong, visited Nanning in Guangxi today (January 14).
This morning, Professor Sun called on the Secretary of the CPC Guangxi Zhuang Autonomous Region Committee and Director of the Standing Committee of the Guangxi Zhuang Autonomous Regional People's Congress, Mr Chen Gang, and learned that Guangxi is accelerating the high-quality development of artificial intelligence and building an industrial co-operation highland for the AI industry facing the Association of Southeast Asian Nations (ASEAN). They also had exchanges and in-depth discussions on further strengthening the co-operation and synergistic development between Hong Kong and Guangxi in various areas including AI, innovation and technology (I&T) parks, data infrastructure, data governance, and nurturing talent. Member of the Standing Committee of the CPC Guangxi Zhuang Autonomous Region Committee and Vice Chairman of the People's Government of the Autonomous Region Ms Lu Xinning also attended the meeting.
Professor Sun said Hong Kong will fully leverage its distinctive advantage of having strong support from the motherland and a close connection with the world. Through complementary co-operation and synergistic development, Hong Kong and Guangxi will explore co-operation between the two places and with ASEAN countries in industries such as AI and the digital economy.
Professor Sun then met with Member of the Standing Committee of the CPC Guangxi Zhuang Autonomous Region Committee and the Secretary of the CPC Nanning Municipal Committee, Mr Xu Yongguo, to exchange views on I&T co-operation between Hong Kong and Nanning.
Professor Sun visited the Display Center of the China-ASEAN Countries Artificial Intelligence Application Cooperation Center and toured its display hall. The Center is an AI co-operation platform, jointly established by the Guangxi Zhuang Autonomous Region and ASEAN countries, which aims to promote regional co-operation in AI technologies and the digital transformation of industries. The center is also an industrial highland facing ASEAN.
He was briefed on the Center's construction and operation, as well as its co-operation with ASEAN countries. He also observed the AI+ industries and application scenarios, including industrialisation and social governance, and exchanged views on the co-operation model of research and development, integration in Guangxi, and applications in ASEAN.
Professor Sun also visited the exhibition centre of the China-ASEAN Information Harbor and the Beibu Gulf Big Data Exchange Center and studied the collaboration in AI between Guangxi and ASEAN countries, as well as the development and transaction of data products. He also learned about the cross-boundary data flow channels and industrial Internet platforms, the construction of the Digital Silk Road, and co-operation with the ASEAN market.
Professor Sun then visited the China-ASEAN Geographic Information Town to study the industrial applications of technologies, such as satellite navigation and geographic information, in the fields of smart city, cross-boundary logistics, and so on.
Meanwhile, Professor Sun visited the China-ASEAN Mercantile Exchange (China-Singapore Nanning International Logistics Park) to learn about the operation of the large-scale cross-boundary integrated logistics park and one-stop trade platform that integrates functions including production, warehousing, logistics, exhibition, commerce and finance. He also studied the international co-operation between ASEAN countries and Guangxi through the Western New Land-Sea Corridor.
Upon his arrival in Nanning, Guangxi yesterday, Professor Sun immediately met with Deputy Secretary-General of the People's Government of the Guangxi Zhuang Autonomous Region, Party Secretary and Director of the Guangxi Big Data Development Bureau Mr Zhao Zhigang, to have an in-depth exchange on issues including the promotion of data sharing, smart city development, and co-operation in digital industry.
The Chief Executive Officer of Hong Kong Cyberport Management Company Limited, Dr Rocky Cheng, also joined the visit.
Professor Sun will continue his visit tomorrow. He will visit a digital intelligent operations and maintenance service provider and its intelligent computing centre to learn about the service provider's latest achievements in AI and computing power, digital intelligence technology and products. He will also visit the China Mobile Group Guangxi Company to conduct studies on the planning of its infrastructure in computing power and its AI industry large models.
Professor Sun will conclude his visit before noon and return to Hong Kong.
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
SITI visits Guangxi Source: HKSAR Government Press Releases
