Newsroom
Pharmeuropa 33.3 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 33.3 is 30 September 2021. Users and interested parties are welcome to comment on these drafts. It...
EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers
Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a...
Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been...
The Council of Europe appoints future EDQM Director
The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021. Petra Dörr comes to the EDQM with more than 25 years of...
European Pharmacopoeia to put an end to the rabbit pyrogen test
At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years. The Ph. Eur. test for pyrogens (general...
European Pharmacopoeia Supplement 10.6 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.6 is now available and will be applicable in 39 European countries as of 1 January 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the European Pharmacopoeia. Subscriptions for print and/or...
PDG’s efforts to engage other ICH pharmacopoeias in the Q4B Annexes maintenance process
At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent...
NEW: As of July 2021, EDQM reference spectra will be sent exclusively by email in PDF format
Please be advised that as of July 2021, EDQM reference spectra will be sent exclusively by email in PDF format and no longer in paper format by courier.
The Eurasian Economic Commission and the EDQM agree to extend and strengthen international collaboration in the circulation of medicines
On 26 May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Eurasian Economic Commission (EEC) signed a memorandum of understanding.
June 14 is World Blood Donor Day! Give blood and keep the world beating
At every moment, someone, somewhere, needs blood.
Blood components – plasma, red cells and platelets – are routinely used to save patients’ lives during surgery, after an accident or during acute illnesses, such as cancer or haemophilia. Regular blood donations are needed to give...
New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP
An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...
Certification monthly report of activities: May 2021
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. May 2021 Certification Monthly Report For more information, access the Certification Database.
Sign up today! EDQM Virtual Training Programme - Modules on Ph. Eur., RS & CEP Procedure
This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia...
2 new reference standards and 20 replacement batches released in May 2021
The EDQM announces the availability of 2 new European Pharmacopoeia (Ph. Eur.) reference standards and 20 replacement batches for Ph. Eur. reference standards.
2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation
A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition to applying to solutions for dialysis, the European Pharmacopoeia requires this test to be...
EDQM releases guidance on paper and board materials and articles for food contact
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of...
Revision of the document “Implementation of policy on elemental impurities in the Certification Procedure”
The EDQM document “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances...
“ISBT in Focus!” – 31st regional congress of the ISBT (2-8 June 2021)
The EDQM will be participating in the 31st regional congress of the International Society of Blood Transfusion (ISBT) – “ISBT in Focus!” – which will take place online from 2 to 8 June 2021. Come and visit the EDQM’s virtual stand and find out more about our organisation and its activities...
New Pharmeuropa Bio & Scientific Notes article: Pertussis Toxin BRP batch 2
A new article on the successful outcome of the study for the establishment of European Pharmacopoeia Pertussis Toxin Biological Reference Preparation (BRP) batch 2 has been published in Pharmeuropa Bio & Scientific Notes.
Revised monograph Water for injections published for public comment in Pharmeuropa
The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for...