2025 Changes to the Manufacturing Standard and PNEC Table

The AMRIA have undertaken a review of the industry AMR standard in light of two years of implementation experience and the publication of the WHO manufacturing guidance in September 2024. Additionally, the AMRIA has undertaken an annual review of the PNEC table. The AMRIA has worked to more closely align the industry standard and PNEC table with the WHO guidance. Key changes introduced in the May 2025 version of the standard (as compared to the prior September 2022 version of the standard) can be found in this table. Changes to the PNEC table are summarized here. Please click to read the revised standard, the PNEC table, and the supplementary PNEC table in full.

Please note that the effective date of the revised standard is 1 August 2025. It is important to note that existing BSI certificates will remain valid for their three year lifecycle and certification against the revised standard will be from 1 January 2026.