Newsroom European Pharmacopoeia
EDQM publishes 2nd edition of Herbal Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users...
2022 Highlights – EDQM annual report now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...
Ph. Eur. Commission keeps pace with veterinary vaccine development efforts
The first DNA vaccine granted a marketing authorisation in the European Union (EU) dates back to 2016 and is intended to protect Atlantic salmon against salmon pancreas disease (SPD) caused by salmon alphavirus subtype 3. Veterinary vaccine manufacturers have been developing third generation...
Call for Experts - NANO Working Party (Nanomedicines)
In June 2022, the EDQM organised and hosted a symposium on “Quality requirements for nanomedicines – what role should the European Pharmacopoeia (Ph. Eur.) play?’’, during which the participants expressed a strong interest in having texts on nanomedicines available in the...
European Pharmacopoeia welcomes Kyrgyz Republic as observer state
The European Pharmacopoeia Commission has granted observer status to the Kyrgyz Republic. This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 32 observers from around the world in addition to 39 European countries and the European Union as signatory...
SAVE THE DATE! Joint USP-EDQM Symposium on "Pharmaceutical Reference Standards"
The USP is pleased to announce it is co-organising a symposium with the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, entitled “Pharmaceutical Reference Standards”. It will take place in Rockville, Maryland (USA) from 27 to 28 September 2023....
Current options for shipping to Ukraine
The EDQM is able to offer several options for shipments to Ukraine. Please consult the linked table: “EDQM shipping options for Ukraine”.
PDG makes significant progress in its harmonisation efforts
The Pharmacopoeial Discussion Group (PDG)¹ works to harmonise the technical content of selected excipient monographs and general chapters (more information here). An important step forward in the harmonisation effort has been achieved recently for a number of texts. New sign-offs Numerous texts...
Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components
Messenger RNA (mRNA) vaccines have been at the forefront of vaccine development efforts during the COVID-19 pandemic. With two authorised mRNA-based vaccines on the market, the mRNA vaccine field continues to evolve, as this increasingly important technology can be tailored to fight different...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 March 2023.
European Pharmacopoeia Supplements 11.3 to 11.5 – 2024 subscriptions now open!
The 2024 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.3 to 11.5, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...
Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2
At its 170th session (June 2021), the European Pharmacopoeia Commission (EPC) agreed to elaborate a new general chapter, Phage therapy active substances and medicinal products for human and veterinary use (5.31), and assigned the task to the newly created Bacteriophages Working Party (BACT WP)....
Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023
The European Pharmacopoeia Commission (EPC) held its 175th session on 21 and 22 March 2023. The 84 texts adopted by the EPC at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.4 (October 2023), with an implementation date of 1 April 2024. These 84 texts included...
European Pharmacopoeia Commission creates new Excipients Strategy Working Party
During its 173rd session in June 2022, the European Pharmacopoeia Commission (EPC) approved the creation of a new Excipients Strategy Working Party (EXS) (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The EXS Working Party will focus on continuing to...
Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts
As announced in the press release on 6 January 2023, the Pharmacopoeial Discussion Group (PDG) held its annual autumn meeting on 18-21 October 2022. In attendance were the three established members of the PDG – the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United...
The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Partnership for Alternative Approaches to Animal Testing (EPAA) have just held a highly successful three-day joint event aimed at phasing out the rabbit pyrogen test (RPT) from the testing of...
Shutdown of European Pharmacopoeia 10th Edition
The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. Consequently, the 10th Edition online and all previous versions, including the Ph. Eur. archives for 10th Edition clients, have no longer been accessible since 31 January 2023. The Ph. Eur. 11th Edition and...
Public consultation on Ph. Eur. rabbit pyrogen test replacement texts in Pharmeuropa 35.1
The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1, with a commenting deadline of 31 March 2023. These...
Ph. Eur. Commission establishes a dedicated working party on High Throughput Sequencing
At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to create a new Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Also known as NGS, this advanced...
Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures
The European Pharmacopoeia (Ph. Eur.) contains quality standards that are applied in a constantly evolving environment and it is therefore essential that its texts and the procedures they describe consistently reflect current practices. As is the case for any other text, where procedures relating...