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Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
Further to the premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that the distribution quota has been revised. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...
Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
Scientific Assistant – Scientific Procurement
Do you wish to further develop your scientific skills in the procurement of chemical and biological substances?
European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.). Both chapters...
New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website
Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC)...
JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs
The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the...
How to identify the manufacturing sites linked to CEP application (revised document)?
Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2
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 36.2. The table below lists the substances...
Certification monthly report of activities: End of March 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2024 Certification Monthly Report For more information, access the Certification Database.
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
Pharmeuropa 36.2 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 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1st May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the...
7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024
New Ph. Eur. reference standards and Replacement batches for Ph. Eur. reference standards Distribution quota 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 Information on International...
Cannabidiol impurity J CRS now available
The standard cannabidiol impurity J CRS that is described in the monograph on Cannabidiol (3151) is now available for users under catalogue code Y0002436. More information on how to order is available on the EDQM website.
Revised Regulation for the Ozone-Depleting Substances
Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed. Under the new regulation, standards...
How CEP holders can avoid the rejection of notifications
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
Stakeholder consultation – New draft technical guide on FCM compliance
Stakeholder consultation – New draft technical guide on FCM compliance A new draft technical guide on documentation supporting compliance and safety of food contact materials and articles is now open for comment. The European Directorate for the Quality of Medicines & HealthCare (EDQM) invites...
The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!
A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...
Certification monthly report of activities: End of February 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.
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