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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...
OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines
The 27th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) was held from 13 to 17 June 2022 at the Council of Europe, in Strasbourg (France). Over 230 participants – from 36 countries and representing 60 OMCLs – attended this meeting organised by the...
EDQM ISO 9001:2015 certification renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....
Certification monthly report of activities: End of May 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.
16 replacement batches released in May 2022
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 Medicines...
OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...
Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs
8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...
Call for experts: join the Ph. Eur. network!
The European Pharmacopoeia (Ph. Eur.) is seeking independent scientific experts to join its groups of experts and working parties. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the...
Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs). The adoption of...
European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!
The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...
Certification monthly report of activities: End of April 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.
New BSP study publication: Heparin Low-Molecular-Mass for Assay BRP
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 is now available online. The article has been published in Pharmeuropa...
New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form. This policy differentiates between hydrates, which have...
Council of Europe adopts recommendation on developing and optimising programmes for the donation of organs after the circulatory determination of death
The Committee of Ministers of the Council of Europe adopted Recommendation CM/Rec(2022)3 on the development and optimisation of programmes for the donation of organs after the circulatory determination of death in February 2022. Each year thousands of patients die or endure poor quality of life...
New general text on comparability of alternative analytical procedures: European Pharmacopoeia launches public consultation
The European Pharmacopoeia (Ph. Eur.) at the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on its new general text on the comparability of alternative analytical procedures (5.27). The draft text elaborates on the requirement expressed more succinctly...
New Pharmeuropa Bio & Scientific Notes article now online: Human immunoglobulin for ACA BRP
A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022. Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human...
Proceedings of Workshop on alternatives to animal testing in Quality Control of Veterinary Vaccines now available
The proceedings of the workshop "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" have been published in FreePub, a free online EDQM journal. The event, held in March 2021, was jointly organised by the European Directorate...
EDQM sticker no longer to appear on Certificates of suitability
As of the 1 May 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) sticker will no longer appear on Certificates of suitability to the European Pharmacopoeia monographs (CEPs). This adhesive sticker (see picture) will no longer be pasted on CEPs next to the wet...
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