Newsroom European Pharmacopoeia
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...
SNOMED International and the EDQM collaborate on map development
SNOMED International and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement governing the creation, maintenance and distribution of a map between both organisations’ terminologies. The agreement came into effect in September...
European Paediatric Formulary: Simple syrup (preservative-free) monograph published
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Simple syrup (preservative-free), to the European Paediatric Formulary. The monograph was published in Issue 4 of Pharmeuropa PaedForm in January 2022, approved by the European Pharmacopoeia...
Call for experts – Aluminium in parenteral nutrition solutions
Although certain European countries already regulate aluminium in parenteral nutrition solutions (PNS), there are currently no European standards limiting the maximum amount of aluminium in these solutions, which are often prepared extemporaneously. To address this situation, the European...
Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022
The European Pharmacopoeia Commission (EPC) held its 174th session on 22 and 23 November 2022. The 85 texts adopted by the Commission at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023), with an implementation date of 1 January 2024. These 85 texts...
Ph. Eur. Commission welcomes Ethiopian FDA as observer
The European Pharmacopoeia (Ph. Eur.) Commission granted observer status to the Ethiopian Food and Drug Administration (EFDA) during its 174th session (November 2022). This decision demonstrates the dynamism of the European Pharmacopoeia, which now has 31 observers from around the world, in...
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines
At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine...
Pharmacopoeial Discussion Group achievements
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 observer, held its annual autumn meeting from 18 to 21 October 2022. Due to...