Implementation of the new PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-18) - revised Annex 19.

The National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, wishes to inform all pharmaceutical manufacturers and industry stakeholders that the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published the revised Guide to Good Manufacturing Practice for Medicinal Products (PE 009-18), which came into force on 24 September 2026. The PIC/S 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).

Key Revision Highlights:

• Incorporates the revised Annex 19 (Reference and Retention Samples).
• Maintains regulatory alignment and harmonization between the PIC/S and European Medicines Agency (EU) GMP Guides.

Implementation Timeline: As the participating authority of PIC/S, NPRA will officially adopt PE 009-18 as the reference standard for GMP inspections, effective 24 September 2026.

All manufacturers and relevant stakeholders are advised to review the updated guide and ensure that internal Quality Management Systems (QMS) and operational documentation are updated accordingly.

The official guide is available for download on the PIC/S portal.