Newsroom European Pharmacopoeia
PDG welcomes Indian Pharmacopoeia Commission to pilot for global expansion
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is delighted to welcome the Indian Pharmacopoeia Commission...
New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques
Following queries received from users through the EDQM HelpDesk, new FAQs on the application of revised general chapter 2.2.46. Chromatographic separation techniques (11.0) has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This is...
European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021. This new general chapter describes a bacterial endotoxins test (BET) that can be used as an alternative to...
New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia
A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its session in November 2021. This new general text elaborates on the requirement...
Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), described as plastic additive 01 in Ph. Eur. general chapter 3.1.14....
11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version. Don’t delay, order your subscription now! This latest edition contains numerous revised and new texts, reflecting the latest scientific and technological progress and regulatory developments in the...
Call for experts: join the Ph. Eur. network
Pharmaceutical analytical procedures related to quality control methods for antibiotics
The European Pharmacopoeia Commission elects its two new Vice Chairs
The European Pharmacopoeia (Ph. Eur.) Commission is pleased to announce the nomination of two new Vice Chairs, elected at its 173rd session held on 22 and 23 June 2022. Dr Eugenia Cogliandro (first Vice Chair) and Dr Marija Malesevic (second Vice Chair), replace outgoing Vice Chairs Prof. S....
Ph. Eur. Commission establishes a new working party on mRNA vaccines
At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...
General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition
General chapter 2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the...
Call for experts: join the Ph. Eur. network
Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products
What’s new for homoeopathic preparations at European level?
First revision of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022) As announced in the press release dated 11 April 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved the revised version of the Guide for the elaboration of monographs on...
Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022
The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...
New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication
At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a...
Pharmeuropa 34.3 just released
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 on Pharmeuropa 34.3 is 30 September 2022. Users and interested parties are welcome to comment on these drafts. It...
Revision of Heparin sodium (0333) and Heparin calcium (0332) monographs – feedback required
First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions...
Pharmacopoeial Discussion Group videoconference meeting
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia with WHO as observer, held its interim videoconference in two sessions on 15 and 28 March 2022. During this videoconference, the PDG discussed...
BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...
Call for experts: join the Ph. Eur. network
Quality control of inorganic substances and synthetic and semi-synthetic organic substances
EDQM ISO 9001:2015 certification renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....