审评审批新政开路，加速引进临床急需境外已上市药品

Core Insights - The new policy from the National Medical Products Administration (NMPA) aims to expedite the entry of globally innovative drugs into China, particularly for rare and chronic diseases, by revising the approval timeline for thousands of foreign drugs already on the market [1][2] Group 1: Policy Changes - The NMPA encourages the application of urgently needed foreign drugs, allowing them to be included in the priority review and approval process [1][3] - For rare disease drugs that are urgently needed but not yet available in China, the policy allows for a pre-inspection application process, reducing the registration inspection time from 60 days to 40 days for sample inspections, and from 90 days to 70 days for simultaneous standard review and sample inspection [1][3] - The new policy simplifies previous high inspection requirements, making it easier for rare disease drugs to enter the Chinese market [1][3] Group 2: Industry Impact - The new policy is expected to significantly impact the pharmaceutical industry by accelerating the market entry of urgently needed drugs, particularly for rare diseases, thus addressing the issue of drug accessibility for patients [2][5] - The introduction of a mechanism for foreign generic drug applications is anticipated to provide more economical treatment options alongside original drugs, potentially reducing the financial burden on patients [2][5] - The policy encourages pharmaceutical companies to conduct global synchronized research and applications in China, which may lead to better resource allocation and earlier inclusion of China in global research plans [2][5] Group 3: Regulatory Framework - 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] - It allows for the acceptance of foreign clinical data and conditional approvals, which can significantly shorten the time to market and reduce costs [3][4] - The policy also optimizes the risk management mechanism for foreign reviews, allowing for remote inspections, which eases the burden on companies while raising quality control standards [4][5] Group 4: Market Dynamics - The global pharmaceutical industry is projected to face a "patent cliff" of approximately $236 billion from 2025 to 2030, prompting multinational companies to adjust their strategies in China [6][7] - The new policy shifts the focus from a "low-price only" approach to a comprehensive evaluation of clinical value, creating conditions for multinational companies to receive reasonable returns on their products [6][7] - The market for rare disease drugs is expected to become a new growth area, with the policy lowering barriers for these drugs to enter the Chinese market [6][7] Group 5: Future Considerations - The implementation of the new policy may face challenges, including the need for complementary measures, particularly regarding insurance integration [7][8] - The regulatory capacity of relevant agencies will be tested as the new policy significantly compresses review timelines, requiring enhanced human resource allocation and professional capabilities [8][9] - The pharmaceutical sector is expected to see a strong rebound in 2025, driven by AI and innovative drugs, reflecting a qualitative leap in China's innovation capabilities [10][11]