Back Outcome of the 183rd session of the European Pharmacopoeia Commission

EDQM Strasbourg, France 08 December 2025
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Outcome of the 183rd session of the European Pharmacopoeia Commission

The European Pharmacopoeia Commission (EPC) held its 183rd session on 18-19 November 2025. The EPC adopted 81 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Issue 13.1 (April 2026) and be effective as of 1 January 2027.

These 81 texts included 7 new monographs and 2 new general chapters:

  • monographs on Caspofungin acetate (3029), Cabazitaxel (3223), Geranium oil (3005), Chicory root (2948), Cat’s claw bark (2530), Linagliptin (3173) and Nintedanib esilate (3237);
  • general chapters entitled Uniformity of delivered dose of inhalation and nasal preparations (2.9.54), elaborated jointly with the Japanese Pharmacopoeia, and Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43).

The EPC adopted revised versions of 72 texts. These included:

  • general chapters on High-performance thin-layer chromatography of herbal products (2.8.25) and Balances for analytical purposes (2.1.7);
  • two key revisions of general chapters harmonised through the Pharmacopoeial Discussion Group, Particulate contamination: sub-visible particles (2.9.19) and Disintegration of tablets and capsules (2.9.1), to modernise the testing for sub-visible particles in 2.9.19 and harmonise the apparatus for large dosage forms in 2.9.1. 

During this session, the EPC appointed experts for the upcoming three year cycle (2025-2028). More than 1000 experts and chairs joining (or re-joining) over 60 expert groups and working parties will dedicate their time and knowledge to advancing the work of the Ph. Eur. Their voluntary commitment to developing and maintaining standards that serve public health is highly valued. Our collective expertise will ensure that the Ph. Eur. continues to evolve in step with technological progress and regulatory expectations, reinforcing its role as a cornerstone of pharmaceutical quality and safety in Europe.

The EPC also decided to add 17 new elaboration projects to its work programme, including eight individual monographs triggered by the Union list of critical medicines, underscoring the EPC’s commitment to reducing the risk of medicine shortages. The new elaboration projects also comprise a general chapter on analysing nitrites in excipients, intended to help users evaluate these impurities which can be critical in certain cases due to their role in nitrosamine formation.

In the field of the 3Rs, the EPC adopted revised monographs on Tetanus vaccine (adsorbed) (0452) and Tetanus vaccine for veterinary use (0697), both of which now include guidance on alternative in vitro methods – for example, the Binding and Cleavage (BINACLE) method – to replace guinea pig testing for the “Absence of tetanus toxin” test. In addition, another milestone was reached in the Ph. Eur.’s efforts to promote animal-free methods in the field of bacterial endotoxin testing (more information on this to be published soon on the EDQM website).

The full list of adopted texts will be made available on the Ph. Eur. Work Programme web page in the coming weeks.


 

The 184th session of the EPC will take place in hybrid format on 10-11 March 2026.