2023-11-01 00:27:34
The Guangdong Provincial Food and Drug Administration successfully held the first Guangdong-Hong Kong-Macao Greater Bay Area Drug Supervision Collaboration Conference
On October 25, under the guidance of the State Food and Drug Administration, the 2023 Guangdong-Hong Kong-Macao Greater Bay Area Drug Supervision Collaboration Conference, hosted by the Guangdong Provincial Food and Drug Administration, was successfully held in Hengqin, Zhuhai. This meeting is the first Guangdong-Hong Kong-Macao Greater Bay Area drug regulatory collaboration meeting held by the drug regulatory authorities of Guangdong, Hong Kong and Macao. Zhao Junning, member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, and Lu Chongmao, Director of the Medical and Health Bureau of the Hong Kong Special Administrative Region Government, Hong Kong Special Administrative Region Government Director of the Department of Health of the Administrative Region Government, Lam Wenjian, and Director of the Drug Supervision and Administration Bureau of the Macau Special Administrative Region Government, Cai Bingxiang, attended the meeting. The meeting was chaired by Changjiang Xiaodong, Secretary of the Party Leadership Group of the Guangdong Provincial Drug Administration.
At the meeting, the State Food and Drug Administration and the drug regulatory authorities of Guangdong, Hong Kong and Macao jointly summarized the results of the innovative development of drug and medical device supervision in the Guangdong-Hong Kong-Macao Greater Bay Area over the past three years, exchanged the latest developments in drug supervision in the mainland, Hong Kong and Macao, and discussed Two documents, the “Guidelines for Notifying Drug and Medical Device Supervision Risk Information in the Guangdong-Hong Kong-Macao Greater Bay Area (Trial)” and the “Work Plan for the Construction of Traditional Chinese Medicine Standards in the Guangdong-Hong Kong-Macao Greater Bay Area” were adopted, establishing a face-to-face collaboration on drug supervision in the Guangdong-Hong Kong-Macao Greater Bay Area. Meeting mechanism and plan to form a mechanism meeting. Taking this meeting as a new starting point, under the guidance of the State Food and Drug Administration, the drug regulatory authorities of Guangdong, Hong Kong and Macao jointly planned the key tasks for the next stage of the innovation and development of drug and medical device supervision in the Guangdong-Hong Kong-Macao Greater Bay Area.
State Food and Drug Administration: Fully support the high-quality development of the pharmaceutical and medical device industry in the Guangdong-Hong Kong-Macao Greater Bay Area
Zhao Junning pointed out that in October 2020, eight ministries and commissions including the State Food and Drug Administration jointly issued the “Work Plan for the Innovative Development of Drug and Medical Device Supervision in the Guangdong-Hong Kong-Macao Greater Bay Area” (hereinafter referred to as the “Work Plan”) and vigorously promoted its implementation. All six key tasks are The implementation has been effective, and the phased goals have been basically completed. Over the past three years, the drug regulatory authorities of the mainland and Hong Kong and Macao have continuously strengthened exchanges and cooperation, worked together, and worked hard to gather momentum and empower the high-quality development of the Guangdong-Hong Kong-Macao Greater Bay Area, allowing the results of reform and development to benefit the majority of residents in the Greater Bay Area. Next, the State Food and Drug Administration will combine the drug supervision work and the development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area, and follow the work idea of ”focusing on politics, strengthening supervision, ensuring safety, promoting development, and benefiting people’s livelihood” to fully support Guangdong, Hong Kong and Macao. Strengthen cooperation with local governments, continue to deepen the six key tasks of the “Work Plan”, plan at a high level to promote the overall goals and tasks of the next stage of the “Work Plan”, and support the establishment and improvement of the drug and medical device supervision and coordination mechanism in the Guangdong-Hong Kong-Macao Greater Bay Area to promote the three major tasks of Guangdong, Hong Kong and Macao. It connects local medical care and medication and other people’s livelihood public services, provides convenient pharmaceutical and medical device products and services to residents of Hong Kong, Macao and the mainland of the Greater Bay Area, and supports the high-quality development of the pharmaceutical and medical device industry in the Guangdong-Hong Kong-Macao Greater Bay Area.
Zhao Junning said that in the next step, under the framework of the cooperation agreement between the State Food and Drug Administration and the drug regulatory agencies of Hong Kong and Macao, we will continue to vigorously support the building of drug regulatory capabilities in Hong Kong and Macao. Continue to support the integrated development of Hong Kong, Macao and the mainland, increase cooperation in key areas such as drug inspection, drug testing, drug review, medical devices, cosmetics regulations and policies that are of concern to Hong Kong and Macao, and work closely with international organizations such as ICH, PIC/S, and FHH , jointly improve the ability and level of drug supervision.
Hong Kong Medical and Health Bureau: Hong Kong will implement new measures to develop a medical innovation hub
Lu Chongmao introduced the new measures in the “Policy Address” just announced by the Chief Executive of the Hong Kong Special Administrative Region regarding the development of Hong Kong as a medical innovation hub, including the establishment of the “Hong Kong Drugs and Medical Devices Regulatory Center” preparatory office and the establishment of a “first-level approval” for new drugs and devices. ” mechanism to promote cooperation in clinical trial networks between Hong Kong and the Mainland to further leverage Hong Kong’s medical advantages and improve medical standards.
Lu Chongmao expressed the hope that these new measures will attract more local, mainland and overseas drug and medical device companies to choose to conduct R&D and clinical trials in Hong Kong, and build capabilities, acceptance and status at different stages to ensure the final Drug and device approval is recognized internationally and in the Mainland.
Hong Kong Department of Health: Will further improve the drug approval mechanism to maintain Hong Kong’s drug regulatory system at an internationally advanced level
Lam Wenjian introduced the latest progress of Hong Kong’s drug, medical device and traditional Chinese medicine regulatory systems, and emphasized that Hong Kong has been committed to improving the drug regulatory system. In the future, it will further improve the drug approval arrangements so that Hong Kong’s drug regulatory system will continue to remain internationally advanced. level, further consolidating Hong Kong’s global position in pharmaceutical development.
Macau Drug Administration: Macau will continue to promote innovative development of the pharmaceutical industry, protect public health and serve the overall socio-economic development
Cai Bingxiang introduced the work of the Macau Food and Drug Administration on various aspects of drug supervision and management in implementing policies and measures to benefit Macao in the construction of the Guangdong-Hong Kong-Macao Greater Bay Area and the “Master Plan for the Construction of the Hengqin Guangdong-Macao Deep Cooperation Zone” to support the general health industry, including the traditional Chinese medicine industry The sustained development of industries has contributed to the moderate diversification of Macao’s economy. Cai Bingxiang hopes to further strengthen exchanges and collaboration with the mainland and Hong Kong on the basis of good cooperation in the past, and jointly discuss, implement and optimize various drug supervision and management tasks.
Guangdong Provincial Food and Drug Administration: anchoring the strategic positioning of “one point, two places” in the Guangdong-Hong Kong-Macao Greater Bay Area, and continuing to promote the innovative development of drug and medical device supervision in the Guangdong-Hong Kong-Macao Greater Bay Area
Jiang Xiaodong said that the Guangdong Provincial Food and Drug Administration will anchor the “one point, two places” strategic positioning of the Guangdong-Hong Kong-Macao Greater Bay Area, and under the guidance of the State Food and Drug Administration, in accordance with the relevant requirements of the overall goals of the second phase of the “Work Plan”, continue to promote Guangdong, Hong Kong and Macao. Innovation and development work for drug and medical device supervision in the Greater Bay Area.One isFocusing on the “Memorandum of Cooperation on Drug and Medical Device Supervision in the Guangdong-Hong Kong-Macao Greater Bay Area”, we will accelerate the establishment and improvement of the drug supervision coordination mechanism among Guangdong, Hong Kong and Macao.two isContinue to promote the implementation of drug supervision tasks in the Guangdong-Hong Kong-Macao Greater Bay Area, continue to do a good job in the “Hong Kong-Macao Drug and Device Communication” work, take multiple measures to streamline the registration and approval of proprietary Chinese medicines for external use in Hong Kong and Macao, and actively and steadily promote the drug marketing authorization holders in the Guangdong-Hong Kong-Macao Greater Bay Area and The reform of the medical device registrant system will increase efforts to support the development of the traditional Chinese medicine industry in the Hengqin Guangdong-Macao Cooperation Traditional Chinese Medicine Science and Technology Industrial Park.The third isComprehensively coordinate and promote the implementation of the next phase of work to ensure that the policy dividends of the state’s support for the development of the pharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area are effectively released, and bring more benefits and conveniences to the residents of the Guangdong-Hong Kong-Macao Greater Bay Area.
Heads of relevant departments and bureaus and directly affiliated units of the State Administration of Food and Drug Administration, relevant representatives of the Medical and Health Bureau of the Hong Kong Special Administrative Region Government, the Department of Health and the Drug Administration of the Macao Special Administrative Region Government, as well as the Guangdong Branch of the General Administration of Customs, the Guangdong Provincial Development and Reform Commission, and the Department of Commerce A total of 80 people from relevant departments including the National Health Commission, the Market Supervision Bureau, the Food and Drug Administration, the Bureau of Traditional Chinese Medicine, and the Hengqin Commercial Service Bureau attended the meeting. (Contributed by the Administrative Licensing Office of the Provincial Bureau/Photo)
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