24 October 2024 – Hong Kong – Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration (“GBACDEI”) and Hong Kong-Shenzhen Innovation and Technology Park Limited (“HSITPL”) co-hosted the inaugural training seminar for Investigational New Drug Application in Hong Kong yesterday (23 October). The seminar was attended by about 200 experts, scholars, researchers and pharmaceutical representatives from Hong Kong and abroad.
At the training seminar, speakers from the Integrated Operations Department, Pharmaceutical Evaluation Department, and Medical Evaluation Department of GBACDEI presented an overview of the clinical trial application process for new drugs in Mainland China, which entailed the pharmaceutical technical requirements and case studies for clinical trials of chemical drugs and biological products, as well as key considerations for applications involving different stages of clinical trials. The comprehensive presentation served as professional guidance for industry stakeholders that are interested in registering new drugs in Mainland China, aiming to enhance their capability and efficiency of clinical trial for new drugs in Mainland China.
Mr. Vincent Ma, Chief Executive Officer of HSITPL said, “We are honoured to host this training seminar with the support by GBACDEI. Leveraging the synergistic advantages of ‘One Zone, Two Parks’ in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone (“Co-operation Zone”), the Hong Kong-Shenzhen Innovation and Technology Park (“HSITP”) will serve as a proactive ‘super connector’ to bolster biomedical exchanges and cooperation between Mainland China and overseas, as well as to attract more biomedical enterprises to conduct clinical trials in Hong Kong, thereby accelerating the transformation of R&D results and our city’s development as a hub for health innovation.”
“We are excited to partner with GBACDEI in our collaborative efforts to drive I&T ecosystem development. We look forward to further collaborating next year on a series of thematic training workshops and consultation seminars to support our Park enterprises, as well as local and international enterprises, on their expansions into the pharmaceutical market in Mainland China,” Mr. Ma continued.
A representative of GBACDEI stated that, as a directly affiliated institution of the National Medical Products Administration in the Greater Bay Area (“GBA”), GBACDEI aims to implement the development strategies of the GBA by the Central Committee of the Chinese Communist Party and the State Council, accelerating the establishment of a convenient mechanism for the review and approval of pharmaceutical products, thereby promoting the quality development of the biomedical industry in the GBA. Clinical trial is crucial to the R&D transfer of basic research, registration, sales and clinical application. GBACDEI anticipates that this seminar will provide pharmaceutical R&D institutions in Hong Kong with a more thorough understanding of the application and approval processes for new drug clinical trials in Mainland China, assisting them in navigating the complexities of conducting preclinical research and investigational new drugs trials in Mainland China. This will promote the synergistic development between Hong Kong and Mainland China, where the registration and clinical application of Hong Kong new drugs will be expedited to make more suitable and affordable new drugs accessible for patients in need, with greater time efficiency.
This training seminar has further facilitated new drugs in Hong Kong to access the expansive market of Mainland China, enhancing the value chain of Hong Kong's biopharmaceutical industry. Leveraging facilitation measures for cross-boundary exchanges, HSITP will continue to capitalise on the positioning of technological and institutional innovation in the Co-operation Zone to attract pharmaceutical and medical device companies from Mainland China and abroad for clinical trials in Hong Kong. HSITP will support the industry in aligning with national and international pharmaceutical standards to fully maximize Hong Kong’s distinctive advantages of enjoying strong support of the Motherland and being closely connected to the world.
