Newsroom
N-nitrosamine impurities in Ph. Eur. monographs: update on approach
Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...
Important update on N-nitrosamine impurities in substances covered by CEPs
On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...
CEP 2.0: The CEP letter of access is ready for use!
The replacement of the declaration of access box on the CEP document by a separate letter of access is one of the changes introduced with the implementation of the CEP 2.0. The template for this letter is now finalised taking into account comments received during the public consultation. The CEP...
CEP 2.0: implementation date
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a...
Implementation of the European Pharmacopoeia Supplement 11.3 – Notification for CEP holders
Supplement 11.3 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 2024, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.3
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 35.3. The table below lists the substances...
EDQM Director elected Chair of IPRP Management Committee
The International Pharmaceutical Regulators Programme (IPRP) held its 11th Management Committee (MC) meeting in Vancouver (Canada) on 13 and 14 June 2023. The European Directorate for the Quality of Medicines & HealthCare (EDQM), an observer to the IPRP, participated in this meeting. The IPRP...
Certification monthly report of activities: End of June 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2023 Certification Monthly Report For more information, access the Certification Database.
Outcome of the 176th session of the European Pharmacopoeia Commission, June 2023
The European Pharmacopoeia Commission (EPC) held its 176th session on 20 and 21 June 2023. The 67 texts adopted at this session by the EPC will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 (January 2024), with an implementation date of 1 July 2024. These 67 texts included 11...
Pharmeuropa 35.3 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 35.3 is 30 September 2023.
New Pharmeuropa Bio & Scientific Notes article now online: HCV RNA for NAT BRP replacement batch
Following the successful completion of the Biological Standardisation Programme (BSP) study for the establishment of batch 2 of the Hepatitis C Virus (HCV) RNA for nucleic acid amplification techniques (NAT) Biological Reference Preparation (BRP), the outcome has been published in the online...
4 new Ph. Eur. reference standards and 10 replacement batches released in June 2023
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...
European Pharmacopoeia Supplement 11.3 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 is now available and will be applicable in 39 European countries as of 1 January 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic...
Over 100 excipient monographs now with an FRC section in the Ph. Eur.
European Pharmacopoeia (Ph. Eur.) Supplement 11.2, which comes into force in 39 European countries on 1 July 2023, contains five excipient monographs that have been revised to include a section on functionality-related characteristics (FRCs), boosting the total of Ph. Eur. monographs that include...
New Pharmeuropa Bio & Scientific Notes article now online: Assay discrepancies using human coagulation factor VIII chromogenic kits
The outcome of a study to investigate reported assay discrepancies using human coagulation factor VIII chromogenic kits has been published in the online journal Pharmeuropa Bio & Scientific Notes. The study confirmed a significant discrepancy between the commercial chromogenic kits on the market...
European Paediatric Formulary: Furosemide oral solution monograph published for public consultation in Pharmeuropa PaedForm
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released issue 7 of Pharmeuropa PaedForm, in which the draft text for Furosemide 2 mg/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary....
CEP 2.0: List of authorities and organisations which have access to assessment and/or inspection reports.
In line with previous communication on CEP 2.0 related to the Authorities database and the updated Holder’s Commitment, the EDQM has now published the list of authorities and organisations with which the EDQM has a Memorandum of Understanding and/or Confidentiality Agreement in place allowing...
Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’. The draft document for public...
EDQM publishes 2nd edition of Herbal Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users...
Certification monthly report of activities: End of May 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2023 Certification Monthly Report For more information, access the Certification Database.
To help you find the relevant news, filter the list using the categories below.