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Annex 1 (2022) – The Brave New World of Regulatory Compliance

After six years in draft form and through various consultations with Industry, the revision to Annex 1 was finally released in August 2022, and will become effective in August 2023. It is the greatest single change to regulatory approach in decades. 

Those following the journey of the draft Annex 1 through to fruition have already identified and largely anticipated the changes to the previous Annex 1. Indeed for many pharmaceutical manufacturers, Annex 1 now aligns closer with the technologies and processes they have already built into their manufacturing facilities over the last few years. 

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