01.04.2026 [中譯] 2026年4月1日

New EMA GMP Guidelines in the next three Years [中譯] 未來三年的 EMA GMP 指南新趨勢

The European Medicines Agency (EMA) has published a new version of the '3-year work plan for the Inspectors Working Group' covering the period from January 2026 to December 2028. The plan is drawn up by the GMDP Inspectors Working Group (GMDP IWG). [中譯] 歐洲藥品管理局 (EMA) 已發布新版的「稽查員工作小組三年工作計畫」，涵蓋期間自 2026 年 1 月至 2028 年 12 月。該計畫由 GMDP 稽查員工作小組 (GMDP IWG) 擬定。

It also includes, in some cases, revised timelines for the revision of GMP requirements. [中譯] 此計畫在某些案例中亦包含了 GMP 規範要求修訂的時間表調整。

The following chapters and annexes are to be finalised by the end of 2026 ("provide the European Commission with a final text"): [中譯] 以下章節與附錄擬於 2026 年底前完成定稿（即「向歐盟執委會提交最終文本」）：

• Chapter 1 (Pharmaceutical Quality System) [中譯] 第一章（藥品品質系統）
• Chapter 4 (Documentation) [中譯] 第四章（文件化）
• Annex 15 Qualification and Validation [中譯] 附錄 15（確認與確效）
• Annex 22 Artificial Intelligence [中譯] 附錄 22（人工智慧）

At least a review is to be carried out for the "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products". [中譯] 針對「新穎治療藥品 (ATMP) 專屬之優良製造規範指南」至少將進行一次審查。

The procedure for implementing the ICH Q12 guideline "Lifecycle Management" is also to be clarified by the end of the year. [中譯] ICH Q12「生命週期管理」指南的實施程序亦將於年底前予以釐清。

A great deal of work is then planned for the next two years, and the revisions to the following chapters and annexes are to be finalised by the end of 2028: [中譯] 接下來兩年計畫有大量工作進行，以下章節與附錄的修訂擬於 2028 年底前定稿：

• Chapter 3 (Premises and Equipment) [中譯] 第三章（廠房設施與設備）
• Chapter 5 (Production) [中譯] 第五章（生產）
• Chapter 7 (Outsourced Activities) [中譯] 第七章（委外活動）
• Chapter 9 (Self-Inspection) [中譯] 第九章（自我稽查）
• Annex 3 Manufacture of Radiopharmaceuticals [中譯] 附錄 3（放射性藥品之製造）
• Annex 6 Manufacture of Medicinal Gases [中譯] 附錄 6（醫療用氣體之製造）
• Annex 14 Manufacture of Medicinal Products Derived from Human Blood or Plasma [中譯] 附錄 14（人類血液或血漿來源製品之製造）

Further details can be found in the current document The 3-year work plan for the Inspectors Working Group. [中譯] 更多詳情請參閱目前的正式文件：稽查員工作小組三年工作計畫。

Source: https://www.gmp-compliance.org/gmp-news/new-ema-gmp-guidelines-in-the-next-three-years [中譯] 資料來源：https://www.gmp-compliance.org/gmp-news/new-ema-gmp-guidelines-in-the-next-three-years