创新药审评审批提速

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创新药临床试验审批迈入“30日时代”,药企研发迎来“及时雨”|创新药观察
Hua Xia Shi Bao· 2025-06-19 06:49
Core Viewpoint - The National Medical Products Administration (NMPA) has announced a new policy to expedite the clinical trial approval process for innovative drugs, reducing the review time to 30 working days, which represents a 50% acceleration in the approval process [1][2]. Group 1: Policy Changes and Impacts - The new policy aims to prioritize resources for innovative drugs that have significant clinical value, ensuring that only those meeting specific criteria can access the expedited review process [2][4]. - In 2024, the NMPA approved 48 Class 1 innovative drugs, a 20% increase year-on-year, marking the highest number in five years, with over 70% of these approvals achieved through accelerated pathways [2][3]. - The approval of 39 global new drugs in China from January to May 2024, with 34 being domestic innovations, highlights the vibrant growth of China's pharmaceutical innovation [3]. Group 2: Historical Context and Future Outlook - Prior to 2015, the domestic pharmaceutical market primarily followed a model of imitative innovation, with new drugs typically taking 5-7 years longer to launch in China compared to overseas [4]. - The establishment of rapid review channels and the acceleration of key national research projects are expected to enhance China's competitiveness in global pharmaceutical innovation [4][5]. - The recent establishment of review centers in regions like the Yangtze River Delta and the Greater Bay Area aims to improve regulatory efficiency and support the rapid approval of innovative drugs [5]. Group 3: Global Trends - The FDA has also introduced a new priority review program, reducing its approval timeline from approximately 10-12 months to 1-2 months, indicating a global trend towards faster clinical review processes [5].