贯彻落实党的二十届四中全会精神权威访谈|以高效严格监管促进创新药和医疗器械发展——访国家药品监督管理局党组书记、局长李利

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation to promote the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1][2]. Regulatory Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2]. - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2]. Industry Innovation and Development - A total of 220 innovative drugs and 282 innovative medical devices were approved during the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3]. - The NMPA has also approved 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines [3]. Strengthening Regulatory Capacity - The NMPA has revised key regulatory laws and established a more comprehensive legal framework for drug regulation, enhancing the consistency of Chinese standards with international standards [4]. - The establishment of new inspection centers and regional review centers has improved the regulatory capacity of the NMPA [4]. Transition to Proactive Drug Safety Management - The NMPA aims to shift drug safety management from a "passive defense" approach to a "proactive prevention" model, enhancing risk identification and responsibility accountability [5]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [6]. Support for Innovative Drug and Medical Device Development - The NMPA plans to enhance support for the research and development of innovative drugs and medical devices, focusing on policy guidance and resource allocation for original products [7]. - Efforts will be made to streamline the approval process for innovative products and improve the protection of intellectual property rights related to drug research [8]. Ensuring Public Benefit from Regulatory Reforms - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [9]. - The agency will expedite the approval of urgently needed drugs and maintain high standards for generic drug quality to ensure affordable access to effective medications [9]. Collaborative Governance in Healthcare - Strengthening collaboration with health and insurance departments is essential for improving clinical trial oversight and drug traceability [10]. - The NMPA will enhance public awareness of drug safety and regulatory policies through education and outreach initiatives [10].