Back Outcome of the 184th session of the European Pharmacopoeia Commission

EDQM Strasbourg, France 24/03/2026
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Outcome of the 184th session of the European Pharmacopoeia Commission

The European Pharmacopoeia Commission (EPC) held its 184th session on 10-11 March 2026. The EPC adopted 50 European Pharmacopoeia (Ph. Eur.) texts that will be published in Issue 13.2 (July 2026) and will be effective as of 1 April 2027, and approved four new texts for the European Drug Shortages Formulary (EDSForm) and European Paediatric Formulary (PaedForm).

The Ph. Eur. texts included the following five new monographs and two new general chapters:

  • individual monographs on Alectinib hydrochloride capsules (3220), Alectinib hydrochloride (3219), Mint haplocalyx herb (3191), Fritillaria cirrhosa bulb (2586), Spine date seed (2613);
  • a general chapter entitled Bacteriophage potency determination (2.7.38);
  • and a general chapter on Evaporative light scattering detection (2.2.62), adding to the existing set of detection techniques.

The remaining 43 texts were revisions, including:

  • four general chapters on techniques for elemental analysis, revised to modernise and align their content;
  • the general chapter on Alternative methods for control of microbiological quality (5.1.6);
  • the general chapter on Glass containers for pharmaceutical use (3.2.1).

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

As stated above, other highlights of this session included the approval of the first texts for EDSForm, i.e. two general texts providing an introduction to the Formulary and laying down its general principles, together with the first monograph, Amoxicillin 125 mg, 250 mg and 500 mg, capsules. These three texts are scheduled to be published on the new EDSForm platform following their final adoption by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The 12th PaedForm monograph, Lorazepam 1 mg/mL oral solution has followed the same process and will be published on the PaedForm platform.

Other decisions taken by the EPC were the approval of the 3rd Edition of the “Technical guide for the elaboration and use of monographs for veterinary vaccines and IVMPs”, and the creation of a new working party dedicated to the technical development of the certified review of microbiological methods per the European Pharmacopoeia, or “cMEP”. cMEP is a method‑centric approach intended to facilitate the use of alternative microbiological methods by providing a harmonised scientific review of their validation and comparability, in accordance with the Ph. Eur.

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The 185th session of the EPC will take place in hybrid format on 23 and 24 June 2026.