The EDQM has released Issue 13.1 of the European Pharmacopoeia, making available a range of new, revised, corrected and updated texts covering analytical methods, materials, excipients, active substances and pharmaceutical preparations.
The issue is applicable across the 39 member countries of the European Pharmacopoeia Convention and will enter into force on 1 January 2027 for new and revised texts.
According to the publication’s introductory notes, all revised, corrected or deleted sections are identified by triangular change marks.
Each new, revised or corrected text carries its own implementation requirements. For Issue 13.1, all newly introduced and revised texts are scheduled to come into force on 1 January 2027, while corrected texts must be adopted as soon as possible and no later than 31 May 2026.
Issue 13.1 also continues the online-only publication approach introduced with recent editions.
On the European Pharmacopoeia Online platform, each general chapter and monograph includes a status panel indicating whether a text is “not yet in force” or already implemented, together with any relevant correction information.
For cleanroom operators, sterile manufacturers and pharmaceutical quality control laboratories, the update is particularly relevant because it includes revisions to a number of monographs used in the manufacture and testing of sterile products and pharmaceutical ingredients.
Among the revised texts listed in Issue 13.1 are monographs covering Water for Injections, Purified Water, haemodialysis solutions, active pharmaceutical ingredients and a range of finished dosage forms.
The publication also includes corrected texts affecting materials used in pharmaceutical packaging systems.
Corrections were issued for chapters covering materials based on non-plasticised poly(vinyl chloride) for containers for aqueous solutions and oral solid dosage forms, as well as the chapter on plastic additives.
These corrections are required to be implemented no later than 31 May 2026.
As with previous issues, reagent updates form part of the release.
Each reagent is assigned a unique seven-digit reference code for identification and traceability purposes.
Issue 13.1 is the first edition to operate fully under the Pharmacopoeia’s revised publication timetable.
Under the new schedule, adopted alongside the transition to a fully digital platform, the period between publication and implementation has been extended from six months to nine months, giving manufacturers, testing laboratories and regulatory affairs teams additional time to assess and implement changes.
For certificate holders and manufacturers using European Pharmacopoeia monographs as part of their quality systems, the publication triggers the review process for affected specifications, methods and supporting documentation ahead of the January 2027 implementation deadline.
To find out more about the latest industry updates and innovations in aseptic processing and sterile drug manufacturing, meet with solution providers and hear talks from expert speakers, attend the 6th Aseptic BioPharma Processing Summit, taking place September 22-23, 2026, in Vienna, Austria.
For more information, click here or email us at info@innovatrix.eu for the event agenda. Visit our LinkedIn to stay up to date on our latest speaker announcements and event news.
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