PIC/S 通过并生效建议文件 PI 058-1，解读无菌药品生产 Annex 1 主要变更

Adoption and Entry into force of PIC/S Recommendation (PI 058-1) - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022)

AI 导读

PIC/S 于 2026 年 10 月 28 日发布建议文件 PI 058-1，解读 2022 年版无菌药品生产 Annex 1 的主要变更，该文件同日生效。文件由 PIC/S-EMA-WHO 联合实施工作组（A1IWG）的专家小组编写，并经 PIC/S、EMA 与 WHO 正式通过。

推荐理由

材料说明 PI 058-1 由三方联合工作组编写并已生效，可用于对照 Annex 1 修订后的解释要点。

正文 · 原文

Geneva, 28 October 2026 PIC/S has published the Recommendation PI 058-1 - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022). This document was prepared by a sub-group of experts from the PIC/S-EMA-WHO Joint Implementation Working Group (A1IWG) bringing together experts from WHO, EMA, and PIC/S Participating Authorities. The A1IWG was established in January 2024 following the entry into force on 25 August 2023 of the revised Annex 1 on “sterile manufacturing of the PIC/S GMP Guide”. The document, formally adopted by PIC/S, EMA and WHO, was presented to selected Stakeholders during a Briefing Meeting (Webinar) hosted by the EMA on 22 October 2026. PI 058-1 enters into force on 28 October 2026. To download PI 058-1, please consult the page “Publication”