注射用维贝柯妥塔单抗(美佑恒)
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深化药械改革 各地在行动丨审评改革“上海样本”:长三角监管协同如何让创新跑得更快
Xin Hua Wang· 2026-01-19 06:57
Core Viewpoint - The article highlights the significant reforms in China's pharmaceutical and medical device regulatory system, particularly in Shanghai, which have accelerated innovation and improved the regulatory environment for companies in the industry [1][2][21]. Group 1: Regulatory Reforms - The establishment of the Long Triangle drug and medical device review centers has enabled local companies to access regulatory services more conveniently, leading to faster innovation cycles [3][4]. - Shanghai's regulatory reforms include 22 comprehensive measures that enhance the connection between the regulatory system and industry needs, promoting high-quality development in the pharmaceutical sector [14][11]. - The Shanghai model of regulatory reform is becoming a replicable paradigm for other regions, demonstrating the effectiveness of localized innovation in regulatory practices [2][19]. Group 2: Innovation Support - The Long Triangle review centers have processed over 60,000 applications and provided guidance for 239 innovative products, with 99 already approved for market entry [6][10]. - Companies have reported that the regulatory environment in Shanghai allows for more direct communication with reviewers, which has improved the efficiency of the registration process [4][7]. - The establishment of registration guidance service stations has further enhanced support for innovation, with 102 companies receiving targeted assistance in key areas [9][20]. Group 3: Collaborative Ecosystem - The integration of regulatory resources across the Long Triangle region has created a collaborative ecosystem that supports innovation and accelerates product development [19][18]. - Shanghai's role as a "testbed" for national policies has allowed it to attract innovative projects, exemplified by the rapid approval of new drugs and medical devices [17][18]. - The collaboration between Shanghai and neighboring provinces has led to the development of a unified quality management system, enhancing resource efficiency and risk control [19][20].