我国新冠疫苗研制生产的监管特点分析

Analysis of Regulatory Characteristics of COVID-19 Vaccine Development and Production in China

目的:在我国新冠疫苗研制与生产进程加速的背景下,为加强相应的监督管理提供建议。方法:通过查阅文献和公开信息,以及调研,梳理了国内外新冠疫苗的研制、生产与监管的现状。结果与结论:为应对新冠疫情的流行,我国加快了新冠疫苗的研制和生产进程,对此,我国药品监督管理部门与其他相关部门为保证疫苗质量和保障疫苗供应,在可供借鉴的监管经验有限的条件下,探索新冠疫苗研制和生产方面的监管机制和举措,经受了确保新冠疫苗安全有效使用的严峻考验。相对于传统的疫苗监管,新冠疫苗的研制和生产监管具有一定的新特点。

Objective: To provide suggestions for strengthening corresponding supervision and management in the context of accelerated development and production of COVID-19 vaccine in China. Methods: The current situation of the development, production and supervision of COVID-19 vaccines at home and abroad was sorted out by reviewing literature and public information. Results and Conclusion: In response to the COVID-19 pandemic, China has accelerated the development and production process of COVID-19 vaccines. In order to ensure vaccine quality and supply, drug administration department and other relevant departments have explored regulatory mechanisms and measures in the development and production of COVID-19 vaccines, with limited regulatory experience available for reference. They have withstood the severe test of ensuring the safe and effective use of COVID-19 vaccines. Compared with traditional vaccine supervision, the development and production supervision of COVID-19 vaccine has certain new features.