关于疫苗说明书撰写和管理的思考

Consideration on the compilation and management of vaccine package inserts

药品说明书是指导包括疫苗在内的上市药品安全合理使用的重要工具。本文根据现行相关法规和指导原则的要求,结合疫苗的特点,总结了疫苗说明书撰写和修订的基本考虑要点,分析了疫苗说明书在撰写、修订和管理方面存在的问题,提出了相应的建议。

Drug package inserts are the main tools to guide safe and legal use of licensed drugs and vaccines. Based on relevant requirements, regulations, and guidelines, combined with characteristics of vaccines, we summarize basic considerations for compiling and revising vaccine package inserts. We describe issues in the compilation, revision and management of vaccine package insert instructions and provide legal programmatic suggestions for their revision, management, and use.