Newsroom
Certification monthly report of activities: End of May 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2023 Certification Monthly Report For more information, access the Certification Database.
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...
16 replacement batches released in May 2023
Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Change of sales units / price Information on change of amount per unit Change of EDQM storage/shipping conditions...
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...
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...
Certification monthly report of activities: End of April 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2023 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standard and 18 replacement batches released in April 2023
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference...
Remote and online provision of medicines: EDQM targeted stakeholder consultation
From 13 March to 26 May 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft Council of Europe recommendation on best practices for the remote and online provision of medicines....
EDQM publishes 21st edition of the Blood Guide, providing state-of-the-art guidance for healthcare professionals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 21st edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide). The Blood Guide is a compendium of widely accepted, harmonised European technical standards...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 March 2023.
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.2
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 35.2. The table below lists the substances...
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...
Independent control of COVID-19 vaccines: article co-authored by the EDQM and members of the OCABR Network published in npj Vaccines
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and members* of the Official Control Authority Batch Release (OCABR) Network of the General European OMCL Network (GEON) have co-authored an article entitled “Independent Control of COVID-19 Vaccines by EU Official Control...
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...
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.1
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 35.1. The table below lists the substances...
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...
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