Swissmedic 与行业协会澄清外国制造商 GMP 合规评估未决问题并例外公布圆桌会议纪要
GMP compliance by foreign manufacturers
Swissmedic 与行业协会在 2026 年 8 月 13 日 GMP/GDP 特别圆桌会议上，澄清并共同制定了生产许可申请中外国制造商 GMP 合规评估未决问题的具体解决方案。这些方案预计可简化流程并提高效率。Swissmedic 表示，鉴于该议题的重要性，此次例外公布圆桌会议纪要。
材料说明 Swissmedic 与行业协会就外国制造商 GMP 合规评估的未决问题共同提出解决方案，并例外公布会议纪要。
GMP compliance by foreign manufacturers
Simplifications for industry and clarification of unresolved issues
09.10.2026
At the extraordinary Round Table on GMP/GDP on 13 August 2026, Swissmedic and the industry associations clarified unresolved issues on the assessment of GMP compliance by foreign manufacturers in the context of authorisation applications and jointly developed specific solutions and problem-solving approaches.
These are expected to simplify processes and make them more efficient. Given the importance of this subject, Swissmedic is, by way of an exception, publishing the minutes of the Round Table.
来源：Swissmedic 药品质量与 GMP 更新 · swissmedic.ch