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MIRCA: An EDQM tool to enhance safe use of substances of human origin
The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently unveiled the Microbiological Risk of Contamination Assessment tool (dubbed “MiRCA”), which aims to improve the safety and efficacy of substances of human origin (SoHO) used for therapeutic purposes. The MiRCA tool,...
CEP 2.0 - Public consultation: CEP letter of access
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking input from Certification of suitability (CEP) users for the implementation of the CEP 2.0.
CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications
As part of the implementation of the CEP 2.0, it will be mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers....
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....
Certification monthly report of activities: End of February 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2023 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standards and 15 replacement batches released in February 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 See also: Content of the Ph. Eur. RS catalogue How...
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...
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...
International call for tenders for the provision of communication products and services (2023AO13)
The European Directorate for the Quality of Medicines & HealthCare (EDQM), a directorate of the Council of Europe, is launching an international call for tenders for the provision of communication products and services (2023AO13). Please find the link to the Tender file:...
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...
24 replacement batches released in January 2023
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 Directorate for the Quality of...
Certification monthly report of activities: End of January 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2023 Certification Monthly Report For more information, access the Certification Database.
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...
CEP holders – How to submit a nitrosamine risk assessment
To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Minor revisions should be submitted for revised...
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...