European Pharmacopoeia Issue 13.3 published: 93 new and revised texts

In October 2026 the European Directorate for the Quality of Medicines & HealthCare (EDQM) published Issue 13.3 of the European Pharmacopoeia (Ph. Eur.). The issue contains 93 texts adopted at the 185th session of the European Pharmacopoeia Commission, held on 23–24 June 2026.

The texts of the new issue come into force on 1 July 2027 in the 39 member states of the Convention on the Elaboration of a European Pharmacopoeia. The deadline for corrected texts is 30 November 2026.

Notable changes in this issue:

• new general chapter 2.5.46 on phenolic antioxidants in plastic materials (in force from 1 July 2027);
• a new monograph on Bluetongue vaccine (inactivated);
• revised texts of existing general chapters and individual monographs.

From the 13th Edition onwards, each issue of the European Pharmacopoeia is published about nine months before its implementation date. This gives manufacturers and quality control laboratories enough time to prepare for the new requirements.

The second edition of the State Pharmacopoeia of the Republic of Uzbekistan is being prepared in harmonisation with the European and United States Pharmacopoeias, so changes in Ph. Eur. texts are monitored continuously.

Source: European Directorate for the Quality of Medicines & HealthCare (EDQM). See the official announcement for details.

Background: the EDQM is a directorate of the Council of Europe that publishes the European Pharmacopoeia and sets quality standards for medicines. A general chapter is a pharmacopoeial text defining analytical methods and general requirements; a monograph sets the quality requirements for a particular substance or medicinal product.