EDQM 发布 Pharmeuropa 38.4，35 个欧洲药典草案公开征求意见至 2026 年 12 月 30 日

Pharmeuropa 38.4 just released

EDQM Strasbourg, France 01/10/2026

All new European Pharmacopoeia (Ph.Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments onPharmeuropa 38.4is 30 December 2026.

Users and interested parties are welcome to comment on these drafts. It should be noted that:

• although draft monographs must not be regarded as official standards, they will, once adopted by the Ph.Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph.Eur. member states;
• if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.

It is therefore extremely important that users provide feedback on such drafts.

Comments made after adoption of the text and/or publication in the Ph.Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph.Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.

So****don’t miss this opportunity to provide your comments. The 35 drafts published in Pharmeuropa 38.4 are listed here.

Drafts published in Pharmeuropa 38.4 (end of commenting period: 30**December 2026)Group 1**2.5.32. Water: micro determination
Reference number: PA/PH/Exp. MG/T (26) 7 ANP
Text number: 20532
Direct linkMG 22.6.16. Tests for extraneous agents in viral vaccines for human use
Reference number: PA/PH/Exp. 15/T (25) 3 ANP
Text number: 20616
Direct link15 32.8.18. Determination of aflatoxin B1 in herbal drugs
Reference number: PA/PH/Exp. 13B/T (26) 39 ANP
Text number: 20818
Direct link13B 42.9.58. Adhesive properties of patches and medicated plasters
Reference number: PA/PH/Exp. 12/T (26) 12 ANP
Text number: 20958
Direct link12 52.9.9. Measurement of consistency by penetrometry
Reference number: PA/PH/Exp. 12/T (24) 6 ANP
Text number: 20909
Direct link12 63.1.19. (Ethylene-methacrylic acid) - zinc copolymer
Reference number: PA/PH/Exp. 16/T (26) 18 ANP
Text number: 30119
Direct link16 75.2.3. Cell substrates for the production of vaccines for human use
Reference number: PA/PH/Exp. 15/T (25) 4 ANP
Text number: 50203
Direct link15 8Anthrax spore vaccine (live) for veterinary use
Reference number: PA/PH/Exp. 15V/T (25) 10 ANP
Text number: 0441
Direct link15V 9Ceritinib
Reference number: PA/PH/Exp. P4/T (22) 23 ANP
Text number: 3181
Direct linkP4 10Cloprostenol sodium for veterinary use
Reference number: PA/PH/Exp. 10B/T (26) 41 ANP
Text number: 1715
Direct link10B 11Dabrafenib mesilate
Reference number: PA/PH/Exp. P4/T (21) 16 ANP
Text number: 3184
Direct linkP4 12Estradiol hemihydrate
Reference number: PA/PH/Exp. 10B/T (26) 75 ANP
Text number: 0821
Direct link10B 13Immunosera for human use, animal
Reference number: PA/PH/Exp. 15/T (26) 12 ANP
Text number: 0084
Direct link15 14Iron sucrose complex
Reference number: PA/PH/Exp. NBC/T (14) 11 ANP R1
Text number: 2753
Direct linkNANO 15Manganese glycerophosphate hydrate
Reference number: PA/PH/Exp. 9/T (26) 21 ANP
Text number: 2163
Direct link9 16Microcrystalline wax
Reference number: PA/PH/Exp. 13H/T (26) 26 ANP
Text number: 2399
Direct link13H 17Mitoxantrone hydrochloride
Reference number: PA/PH/Exp. 11/T (24) 99 ANP R3
Text number: 1243
Direct link11 18Paraffin, hard
Reference number: PA/PH/Exp. 13H/T (26) 27 ANP
Text number: 1034
Direct link13H 19Patches
Reference number: PA/PH/Exp. 12/T (24) 37 ANP
Text number: 1011
Direct link12 20Pharmaceutical preparations
Reference number: PA/PH/Exp. 12/T (26) 28 ANP
Text number: 2619
Direct linkPHP 21Plasters, medicated
Reference number: PA/PH/Exp. 12/T (26) 34 ANP
Text number: 3032
Direct link12 22Premixes for medicated feeding stuffs for veterinary use
Reference number: PA/PH/Exp. 12/T (25) 16 ANP
Text number: 1037
Direct link12 23Propyl gallate
Reference number: PA/PH/Exp. 10A/T (26) 49 ANP
Text number: 1039
Direct link10A 24Sodium glycerophosphatehydrate
Reference number: PA/PH/Exp. 9/T (26) 20 ANP
Text number: 1995
Direct link9 25Sulfamerazine
Reference number: PA/PH/Exp. SIT/T (26) 21 ANP
Text number: 0358
Direct link7 26Suppression of Chloroquine sulfate
Reference number: PA/PH/Exp. 11/T (26) 54 ANP
Text number: 0545
Direct link11 27Suppression of Digitalis leaf
Reference number: PA/PH/Exp. 13B/T (26) 42 ANP
Text number: 0117
Direct link13B 28Suppression of Hyoscyamine sulfate
Reference number: PA/PH/Exp. 11/T (26) 53 ANP
Text number: 0501
Direct link11 29Suppression of Stramonium leaf
Reference number: PA/PH/Exp. 13B/T (26) 40 ANP
Text number: 0246
Direct link13B 30Suppression of Stramonium, prepared
Reference number: PA/PH/Exp. 13B/T (26) 41 ANP
Text number: 0247
Direct link13B 31Triptorelin
Reference number: PA/PH/Exp. 6/T (19) 22 ANP
Text number: 3055
Direct link6 32Vaccines for human use
Reference number: PA/PH/Exp. 15/T (25) 6 ANP
Text number: 0153
Direct link15 33Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids
Reference number: PA/PH/Exp. 15V/T (26) 14 ANP
Text number: 2151
Direct link15V 34Wool fat
Reference number: PA/PH/Exp. 13H/T (25) 98 ANP
Text number: 0134
Direct link13H 35Wool fat, hydrous
Reference number: PA/PH/Exp. 13H/T (26) 66 ANP
Text number: 0135
Direct link13H