在中国药品监管体系不断深化改革的大背景下，上海作为先行先试的城市，通过实施“三个转变”的监管策略，有效促进了生物医药产业的发展。这“三个转变”包括从“监管型”治理向“服务型”治理的转变，从“事后处置型”向“事前预防型”的转变，以及从“经验管理型”向“数智治理型”的转变。
首先，上海在药品和医疗器械的审评审批中采取主动服务的态度，不仅把好安全关，还为企业提供跨前服务。例如，国产质子治疗系统的研发过程中，上海市药监部门提前介入，为企业提供专业支持，最终使得该系统在2022年9月成功获批上市，填补了国内高端医疗装备自主可控的空白。
其次，上海的监管部门从单纯的事后处罚转变为提前预防风险，通过检查和帮扶企业，帮助经营主体排查隐患，努力将监管工作前置，确保生产安全。例如，上海一家中医药企业在搬迁过程中发现生产工艺参数变化，在监管部门的帮助下，企业严格规范生产流程，为保障产品质量打下了坚实的基础。
最后，上海利用数字化、智能化手段，建立了电子数据取证实验室，运用大数据、人工智能等技术，实现了对药品销售等行为的精准高效监管。电子数据取证平台的运用，为案件的查办提供了重要证据链，有效打击了违法违规行为。
随着“三个转变”的深入推进，上海生物医药产业快速发展，产业规模去年已超过9000亿元。这不仅提升了上海乃至全国的药品和医疗器械的质量安全水平，也为生物医药产业的发展注入了新的活力。未来，上海将继续贯彻落实党的二十届三中全会精神，强化责任担当，在先行先试的道路上不断探索，为全国乃至全球的生物医药产业创新发展贡献力量。
英语如下：
Title: “Innovative Regulation Catalyzes the Takeoff of the Pharmaceutical Industry”
Keywords: Regulation, Innovation, Pharmaceuticals
Content:
Against the backdrop of China’s continuous deepening reform of its drug regulatory system, Shanghai, as a pioneer in reform and opening-up, has effectively promoted the development of the biopharmaceutical industry through the implementation of a regulatory strategy known as “three shifts.” These shifts include transitioning from a “regulatory” governance model to a “service-oriented” model, from a “post-event response” approach to a “pre-event prevention” approach, and from “experience-based” management to “data-intelligence” governance.
Firstly, Shanghai has taken a proactive service approach in the review and approval of drugs and medical devices, not only ensuring safety but also providing forward-looking services to enterprises. For instance, during the development of a domestic proton therapy system, the Shanghai Drug Administration proactively intervened to provide professional support, which ultimately led to the successful approval and launch of the system in September 2022, filling a gap in domestic high-end medical equipment.
Secondly, the regulatory departments in Shanghai have shifted from purely post-event penalties to early prevention of risks. They do this by inspecting and assisting enterprises to identify potential hazards, striving to move regulatory efforts forward, ensuring production safety. For example, during the relocation of a traditional Chinese medicine company, changes in production process parameters were discovered. With the help of the regulatory department, the company strictly standardized its production processes, laying a solid foundation for product quality.
Lastly, Shanghai has utilized digital and intelligent methods to establish an electronic data forensic laboratory. By employing big data, artificial intelligence, and other technologies, the city has achieved precise and efficient regulation of pharmaceutical sales and other activities. The use of the electronic data forensic platform has provided an important evidence chain for case investigations, effectively combating illegal and irregular activities.
With the deepening implementation of the “three shifts,” the biopharmaceutical industry in Shanghai has rapidly developed, with its scale exceeding 900 billion yuan last year. This not only elevates the quality and safety levels of drugs and medical devices in Shanghai and the nation as a whole but also injects new vitality into the development of the biopharmaceutical industry. In the future, Shanghai will continue to implement the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party of China, strengthen responsibility, continue to explore on the path of pioneering and reforming, and contribute to the innovative development of the biopharmaceutical industry both nationally and globally.
【来源】http://www.chinanews.com/gn/2024/08-03/10262811.shtml
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