Newsroom
Change in EDQM timelines for CEP applications
On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in...
SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)
After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...
EDQM Laboratory’s ISO 17025:2017 accreditation renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results...
Shipments of orders in December: check EDQM order reception deadlines
To check whether orders for publications or reference standards can be shipped in 2021, users are invited to consult the EDQM order reception deadlines for December. The dates by type of item are given in the following document: Order & shipment deadlines – December 2021. See also: Ph. Eur....
PDG signs-off on milestone harmonised general chapter on chromatography
The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for...
Joint presentation of EDQM and DH-BIO about Council of Europe principles of voluntary non remunerated blood donation / prohibition of financial gain with respect to donation at Members of the European Parliament hosted event
Human plasma is the critical component of numerous therapeutic products used in the treatment of life-threatening diseases, including bleeding or immune system disorders and other severe pathologies. In recent years, the global use of and demand for plasma for fractionation have grown and it is a...
5 new Ph. Eur. reference standards and 19 replacement batches released in October 2021
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order The European...
CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4
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 33.4. The table below lists the substances...
Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders
Supplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the...
PDG prepares pilot for global expansion of membership
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 preparing a pilot to integrate additional world...
European Pharmacopoeia device version to be discontinued
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions. The EDQM was the...
Revised osmolality chapter for public comment in Pharmeuropa
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021). The revision work focused on the osmolality reference solutions using...
Registrations open! Brand new Quality Risk Management training for blood establishments
The supply of blood components involves a series of complex processes composed of numerous steps, each carrying intrinsic and extrinsic risks. Blood establishments must continuously adapt to new regulatory and technical requirements in quality management as part of their risk avoidance strategy....
European Day for Organ Donation and Transplantation, 9 October 2021: Join us online to celebrate! #JustSayYesEODD
This year, celebrations for the European Day for Organ Donation and Transplantation (EODD) will take place online on Saturday, 9 October. EODD is an opportunity to discuss organ, tissue and cell donation and transplantation and reflect upon their importance, as well as to thank donors, their...
4 new Ph. Eur. reference standards and 21 replacement batches released in September 2021
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order The European...
Certification monthly report of activities: September 2021
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. September 2021 Certification Monthly Report For more information, access the Certification Database.
New in European Paediatric Formulary: Phosphate oral solution monograph
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Phosphate 60 mg/mL Oral Solution, to the European Paediatric Formulary. Elaborated by a dedicated European Pharmacopoeia (Ph. Eur.) working party, the monograph was initially published in Issue 3...
Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa
A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021. This draft monograph is the outcome of a...
Pharmeuropa 33.4 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 33.4 is 31 December 2021. Users and interested parties are welcome to comment on these drafts. It should...
European Pharmacopoeia Supplement 10.7 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...