摘要
随着生物科学技术和制药工艺的进步,mRNA疫苗在新冠疫情背景下进入了快速发展阶段,其具有研发周期短、生产快速、临床有效性高等优势,但在开发和生产领域存在较多技术难题。药品监管机构如何对mRNA疫苗进行全链条的质量控制也成为一个研究热点。WHO在2021年发布了关于mRNA疫苗的技术指南,本文归纳了该指南的技术要点,结合我国实际情况探讨mRNA疫苗监管关注点,并对未来相关指南体系进行展望。
With the advancement of bioscience technology and pharmaceutical manufacturing process,the mRNA vaccines have entered a stage of rapid development under the background of COVID-19,which have the advantages of short R&D cycle,rapid production and high clinical effectiveness.However there are various technical difficulties in the field of their development and production.How the drug regulatory agencies can implement the quality control of the entire chain of mRNA vaccines has also become a research hotspot.The WHO released technical guidelines on mRNA vaccines in 2021.This article summarizes the key points of WHO guideline,discusses the regulatory concerns based on the actual situation in China and prospects the technical guidelines system in the future.
作者
韩彬
曹萌
成殷
HAN Bin;CAO Meng;CHENG Yin(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)
出处
《上海医药》
CAS
2023年第9期67-70,75,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
mRNA疫苗
WHO指南
研发
监管
mRNA vaccines
WHO guideline
research and development
regulatory
