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《多联疫苗临床试验技术指导原则》发布
多联疫苗是指含有不同种病原体相关抗原的疫苗,采用按生物分类学的"种(Species)"进行定义,用于预 防不同病原微生物引起的疾病。多联疫苗有利于简化免疫程序、减少疫苗接种次数、增加疫苗接种的便 利性和依从性,对于提高疫苗接种率、进一步减轻公共卫生负担具有重要意义。 人民财讯11月19日电,为支持疫苗产业高质量发展,加快推进国产多联疫苗的研发和上市,近日,国家 药监局药审中心发布《多联疫苗临床试验技术指导原则》。《指导原则》主要包括立题相关考虑、临床 试验设计和上市后变更三个部分,适用于多联疫苗的临床研发。 ...
国家药监局:全链条支持疫苗产业高质量发展
Ren Min Wang· 2025-09-26 08:19
Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of vaccine regulation and the need for enhanced oversight and quality assurance in the vaccine industry [1] Group 1: Regulatory Enhancements - The NMPA has been strengthening the vaccine regulatory system and capabilities in recent years [1] - There is an ongoing effort to increase the intensity of vaccine production and distribution oversight [1] Group 2: Strategic Importance of Vaccines - Vaccines are recognized for their strategic, public welfare, and sensitive nature, necessitating strict regulatory measures [1] - The meeting highlighted the need to implement the "four strictest" requirements to ensure compliance [1] Group 3: Industry Development - The NMPA is promoting the digital and intelligent transformation of the vaccine industry [1] - There is an exploration of innovative regulatory mechanisms and methods to enhance oversight [1] Group 4: Risk Management - The meeting underscored the importance of strengthening risk prediction and management to ensure vaccine safety [1] - A comprehensive approach is being taken to support the high-quality development of the vaccine industry [1]
国家药监局:全方位筑牢疫苗安全底线,全链条支持疫苗产业高质量发展
Core Viewpoint - The National Medical Products Administration (NMPA) emphasizes the importance of vaccine regulation and the need for enhanced oversight and quality assurance in the vaccine industry [1] Group 1: Regulatory Enhancements - The NMPA has been strengthening the vaccine regulatory system and capabilities in recent years [1] - There is an ongoing effort to increase the intensity of oversight in vaccine production and distribution [1] Group 2: Strategic Importance of Vaccines - The meeting highlighted the strategic, public welfare, and sensitive nature of vaccine products [1] - The implementation of the "four strictest" requirements is crucial for ensuring accountability among enterprises and local regulatory bodies [1] Group 3: Innovation and Risk Management - The NMPA aims to promote the digital transformation of the vaccine industry and explore innovative regulatory mechanisms [1] - There is a focus on enhancing risk prediction and management to ensure comprehensive vaccine safety [1] - The goal is to support the high-quality development of the vaccine industry across the entire supply chain [1]