Revisions to Annex 1 Officially Published

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The European Union publishes long-awaited changes to Annex 1.

The European Union officially released its revisions to its good manufacturing practice Annex 1 regulatory document on Aug. 25, 2022. These regulations, which pertain to manufacturing sterile drugs in the EU, are set to go into effect exactly one year after its publication, on Aug. 25, 2023.

According to the revised Annex 1: “The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommend that the current version of annex 1, on the manufacture of sterile medicinal products, is revised to reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q10 guidelines” (1).

Originally published in 2008, Annex 1 was most recently revised in 2020. Following the most recent revisions, Annex 1 sits at 59 pages; and when it was originally published it had 16.



  1. EU, Annex 1, vol. 4, page 1, Annex 1: Manufacture of Sterile Medicinal Products (August 2022).

Source: European Commission