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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...
Certification monthly report of activities: End of March 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2022 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. Commission elects its new Chair at 172nd Session
The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd Session on 22 and 23 March 2022. Among other decisions, the Commission elected its new Chair, Professor Salvador Cañigueral. Professor Cañigueral has been first Vice-chair to the Commission since June 2019. He will take up his duties...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.2
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 34.2. The table below lists the substances...
EDQM helping increase tissue donation thanks to a better understanding of post-mortem blood testing practices
Tissue from one deceased donor may be transplanted into as many as 100 individuals, improving their quality of life and even saving their lives (e.g. in the treatment of catastrophic burns). However, the use of tissues of human origin can result in unintentional transmission of disease. Such...
13 replacement batches released in March 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...
New EDQM website, redesigned to better serve your needs – Now online!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...
Metals and alloys used in food contact materials and articles: updated technical guide released for consultation
The 1st edition of the technical guide “Metals and alloys used in food contact materials and articles” (2013) has been completely reviewed by the European Committee for Food Contact Materials and Articles (Partial Agreement) (CD-P-MCA) to account for regulatory developments and recent risk...
EDQM event "Quality requirements for nanomedicines"
The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations – especially lipid-based systems – used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes around the globe has demonstrated that these...
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