2 new reference standard and 19 replacement batches released in January 2022

EDQM 02/02/2022 Strasbourg, France

New Ph. Eur. reference standards 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...

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EDQM OCCL study reports low compliance of “kids’ cosmetics”

EDQM 02/02/2022 Strasbourg, France

A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that “kids’ cosmetics” continue to fail to comply with European quality and safety regulations, finding that 25% of samples were non-compliant with legislative requirements. Decorative cosmetics,...

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How to use the EDQM DCEP sharing tool

EDQM 31/01/2022 Strasbourg, France

The EDQM DCEP sharing tool is a new IT tool used to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. Specific instructions are given to the intended users for the creation and the...

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Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders

EDQM 21/01/2022 Strasbourg, France

Supplement 10.8 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 July 2022, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.1

EDQM 20/01/2022 Strasbourg, France

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 34.1. The table below lists the substances...

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European Paediatric Formulary: two draft texts released for public consultation

EDQM 14/01/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric...

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All you ever wanted to know about procedure 4 but never dared ask!

EDQM 14/01/2022 Strasbourg, France

This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working...

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New for non-liquid, non-parenterally administered veterinary vaccines: maximum bioburden limit replaces sterility requirements

EDQM 13/01/2022 Strasbourg, France

Sterility requirements in non-liquid and non-parenterally administered veterinary vaccine monographs have been replaced by a maximum bioburden limit to allow the development of new innovative vaccine presentation forms while maintaining the same safety guarantees. The revised sterility...

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OMCL fingerprint studies on omeprazole and sildenafil API samples published in scientific journals – Update

EDQM 11/01/2022 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted two market surveillance studies on omeprazole and sildenafil, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021)...

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Certification monthly report of activities: End of December 2021

EDQM 10/01/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. December 2021 Certification Monthly Report For more information, access the Certification Database.

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Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1

EDQM 10/01/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29), published in this quarter’s issue of Pharmeuropa (34.1) for comment...

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3 new reference standards and 11 replacement batches released in December 2021

EDQM 07/01/2022 Strasbourg, France

New Ph. Eur. reference standards 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...

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“CEP of the future”: project update

EDQM 06/01/2022 Strasbourg, France

The consultation phase of the project to design the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) of the future has been completed. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the survey outcome and a roadmap for...

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Pharmeuropa 34.1 just released

EDQM 05/01/2022 Strasbourg, France

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 34.1 is 31 March 2022. Users and interested parties are welcome to comment on these drafts. It should be...

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Veterinary batch release network welcomes VMD, UK, as an observer

EDQM 22/12/2021 Strasbourg, France

The Veterinary Batch Release Network (VBRN) for immunological veterinary medicinal products (IVMPs) and the Veterinary Medicines Directorate (VMD), UK, have signed a memorandum of understanding (MOU) to renew the exchange and collaboration on common activities related to batch release of IVMPs...

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BSP study outcomes published in Pharmeuropa Bio & Scientific Notes

EDQM 21/12/2021 Strasbourg, France

Upon conclusion of a Biological Standardisation Programme (BSP) study, the outcome is made available in Pharmeuropa Bio & Scientific Notes providing readers with useful information regarding the method(s) used and, where appropriate, the value assignment of the established reference standard....

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European Pharmacopoeia Supplement 10.8 now available

EDQM 15/12/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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New-format order confirmation for reference standards and publications

EDQM 10/12/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its order confirmations to make them easier to read, including clearly identifying: the estimated shipping date for each product; any information the EDQM needs from you in order to ship your order; if your...

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Outcome of the 171st session of the European Pharmacopoeia Commission, November 2021

EDQM 06/12/2021 Strasbourg, France

The 171st session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 November 2021. At this session, the Commission adopted 75 texts for publication in the 11th Edition of the European Pharmacopoeia: 66 revised texts and nine new texts, including: the revised and...

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13 replacement batches released in November 2021

EDQM 03/12/2021 Strasbourg, France

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...

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