Fed Regist. 2004 Feb 5;69(24):5551-2.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (the ICH E2C guidance). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In the Federal Register of May 19, 1997 (62 FR 27470), FDA published the ICH E2C guidance, which recommends a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports (PSURs) for drug and biological products. This guidance, an addendum to the ICH E2C guidance, provides additional information on the content and format of PSURs, including clarification of the objectives, general principles, and model for PSURs. This guidance is intended to help harmonize collection and submission of postmarketing clinical safety data.
美国食品药品监督管理局（FDA）宣布发布一份名为《E2C临床安全数据管理附录：已上市药品定期安全更新报告》（ICH E2C指南）的指南。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。在1997年5月19日的《联邦公报》（62 FR 27470）中，FDA发布了ICH E2C指南，该指南为药品和生物制品上市后定期安全更新报告（PSUR）的格式、内容和报告频率推荐了统一标准。本指南作为ICH E2C指南的附录，提供了关于PSUR内容和格式的更多信息，包括对PSUR目标、一般原则和模式的澄清。本指南旨在帮助协调上市后临床安全数据的收集和提交。
