
June 29, 2026 · Pharmaceuticals
EU-GMP Annex 15 Revision: What the Move Toward December 2026 Means for API Manufacturers
The EU-GMP Annex 15 revision will make qualification and validation mandatory for chemical and biological active substance (API) manufacturers, not just finished-product sites. A joint EMA and PIC/S concept paper set the direction, consultation closed in April 2026, and the final text is targeted for publication by December 2026. Here is what the timeline means and how API sites should prepare.
#EU-GMP
By Mussarat Fatima







































































































