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4 new Ph. Eur. reference standards and 16 replacement batches released in September 2022
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information 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...
DCEP Sharing tool user guide revised
The EDQM DCEP Sharing Tool was launched in January 2022 to ensure that EDQM documents could be shared securely between its Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. This new version of the guide to creating and managing user accounts...
Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders
Supplement 11.1 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 2023, and to follow the...
European Pharmacopoeia 11th Edition conference outcomes
Organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Pharmacopoeia 11th Edition Conference, “Collaboration, Innovation and Scientific Excellence”, took place in Strasbourg from 19 to 21 September 2022. Held in hybrid format, the event brought...
Newsletter Transplant 2022 shows a global increase in donation and transplantation figures, lessons learnt from COVID-19 pandemic
The latest edition of the Newsletter Transplant – the international reference in monitoring practice in donation and transplantation of substances of human origin – has just been published. It provides comprehensive information and data on donation and transplantation activities in 2021 from 79...
European Pharmacopoeia Supplement 11.1 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available and will be applicable in 39 European countries as of 1 April 2023. This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for online and/or print versions are...
Call for experts: join the Ph. Eur. network
Quality control methods for biological and biotechnological substances and products
Certification monthly report of activities: End of August 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August Certification Monthly Report For more information, access the Certification Database.
Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available
The Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines. The update includes a revision of the list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for Official Control...
Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), described as plastic additive 01 in Ph. Eur. general chapter 3.1.14....
11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version. Don’t delay, order your subscription now! This latest edition contains numerous revised and new texts, reflecting the latest scientific and technological progress and regulatory developments in the...
Call for experts: join the Ph. Eur. network
Pharmaceutical analytical procedures related to quality control methods for antibiotics
The European Pharmacopoeia Commission elects its two new Vice Chairs
The European Pharmacopoeia (Ph. Eur.) Commission is pleased to announce the nomination of two new Vice Chairs, elected at its 173rd session held on 22 and 23 June 2022. Dr Eugenia Cogliandro (first Vice Chair) and Dr Marija Malesevic (second Vice Chair), replace outgoing Vice Chairs Prof. S....
Ph. Eur. Commission establishes a new working party on mRNA vaccines
At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...
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Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products
Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online
Following the adoption of batch 4 of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for human immunoglobulin for electrophoresis by the Ph. Eur. Commission, the outcome of the establishment study has been published in Pharmeuropa Bio & Scientific Notes, a freely...
Certification monthly report of activities: End of June 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June Certification Monthly Report For more information, access the Certification Database.
Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022
The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...
Implementation of the 11th Edition of European Pharmacopoeia – Notification for CEP holders
The 11th Edition 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 January 2023, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.3
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 34.3. The table below lists the substances...
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