PIC/S 修订 GMP 指南并纳入修订版附录19，PE 009-18 将于2026年9月24日生效

Geneva, 23 September 2026:The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include the revised Annex 19 (Reference and Retention Samples).The revision of PIC/S Annex 19 primarily concerns Section 9, which addresses reference and retention samples for parallel imported, parallel distributed, and parallel traded products. The note clarifying that Section 9 applies only where local legislation covers parallel imported, parallel distributed, or parallel traded products — present in the previous version of the PIC/S GMP Guide (PE 009-17) — has been retained in the current version (PE 009-18).This update aligns with the Co-operation Agreement between PIC/S and the EMA, which mandates the harmonisation of PIC/S and EU GMP Guides. The aim is to maintain equivalent GMP standards, thereby facilitating the exchange and use of information concerning the manufacture of medicinal products, in line with PIC/S' mission to lead the international development, implementation, and maintenance of harmonised GMP standards and quality systems for inspectorates in the field of medicinal products.The revised Annex 19 was successfully adopted by the PIC/S Committee by written procedure on 22 September 2026. The revised GMP Guide (PE 009-18), with the revised Annex 19 will enter into force on 24 September 2026. This coincides with the entry into force of the revised Annex 19 in the EU following the publication by the European Commission of the revised Annex 19 on Eudralex Volume 4 on 23 June 2026.All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annex 19 of the PIC/S GMP Guide into their own GMP Guides.To download the revised GMP Guide (PE 009-18), please consult the “Publications” page.