Pharmeuropa 38.4 released: comments on 35 European Pharmacopoeia drafts accepted until 30 December

On 1 October 2026 the European Directorate for the Quality of Medicines & HealthCare (EDQM) released Pharmeuropa 38.4. It contains 35 drafts of new and technically revised European Pharmacopoeia (Ph. Eur.) texts for public consultation. Comments are accepted until 30 December 2026.

Key drafts

• general chapters: 2.5.32 Water: micro determination, 2.6.16 Tests for extraneous agents in viral vaccines for human use, 2.8.18 Determination of aflatoxin B₁ in herbal drugs, 2.9.58 Adhesive properties of patches and medicated plasters, 2.9.9 Measurement of consistency by penetrometry, 5.2.3 Cell substrates for the production of vaccines for human use;
• dosage forms and general monographs: Pharmaceutical preparations, Patches, Plasters, medicated, Vaccines for human use;
• substance monographs: ceritinib, dabrafenib mesilate, triptorelin, mitoxantrone hydrochloride, estradiol hemihydrate, propyl gallate, sulfamerazine, iron sucrose complex and others;
• proposed suppression of five monographs: Chloroquine sulfate, Digitalis leaf, Hyoscyamine sulfate, Stramonium leaf, Stramonium, prepared.

The EDQM stresses that draft monographs, once adopted by the Ph. Eur. Commission, become legally binding standards in all Ph. Eur. member states. General texts become mandatory when referred to in a monograph, so changes to them affect monographs too. Comments made after adoption cannot be considered.

The drafts are available in Pharmeuropa online; the list with links to each text is on the EDQM website.

For reference: Pharmeuropa is the official online publication in which drafts of new and revised European Pharmacopoeia texts are put out for public consultation.

Source: EDQM.