临床急需的境外药品，将加速入华

Core Viewpoint - The new policy from the National Medical Products Administration (NMPA) aims to expedite the entry of globally innovative drugs into China, significantly altering the approval timeline for thousands of foreign drugs already on the market, particularly for rare and chronic diseases [1][3]. Group 1: Policy Changes - The NMPA encourages the application of clinically urgent foreign drugs and allows for priority review and approval for those that meet specific criteria [1][3]. - A new pre-inspection method for rare disease drugs will reduce the registration inspection time from 60 days to 40 days for sample inspections, and from 90 days to 70 days for standard review and sample inspection [1][3]. - The policy establishes a communication channel for applicants to discuss data utilization and priority review with the drug review center before formal application submission, which is crucial for expediting the process [3][4]. Group 2: Special Provisions for Rare Diseases - The new policy allows for the acceptance of foreign data and conditional approvals, which can exempt domestic clinical trials, thus shortening the time to market and reducing costs [3][4]. - A special inspection system for rare disease drugs has been established, allowing for a minimum sample size of two batches instead of three, addressing the challenges of sample scarcity and time constraints in rare disease research [3][4]. Group 3: Regulatory and Market Implications - The policy optimizes the overseas review and risk management mechanisms, allowing for remote inspections, which reduces the burden on companies while raising standards for quality control and transparency [4]. - Temporary import channels for urgently needed drugs during the application process have been established, particularly benefiting rare disease medications [4][5]. - The overall regulatory environment is shifting from a focus solely on low prices to a comprehensive evaluation of clinical value, enabling multinational pharmaceutical companies to achieve reasonable returns by demonstrating the clinical value of their products [7][8]. Group 4: Market Trends and Future Outlook - The global pharmaceutical industry is expected to face a "patent cliff" with approximately $236 billion at stake from 2025 to 2030, prompting multinational companies to adjust their strategies in China [7]. - The Chinese pharmaceutical market is evolving into a dual focus on both importing innovative drugs and supporting domestic innovation, with significant growth in the innovative drug sector [11][12]. - The NMPA approved a record 4,087 drug registration applications in 2025, including 76 innovative drugs, indicating a significant acceleration in the approval process [12][14].