Reorganisation of the Romanian blood system – NEW Deadline for tendering: Consultants for the provision of local co-ordination services

EDQM 21/01/2021 Strasbourg, France

The EDQM/Council of Europe will implement the “Reorganisation of the Romanian Blood System” project. The project aims to support Romania in setting up a fit-for-purpose and efficient blood transfusion system aligned with European Union and EDQM standards. The EDQM is therefore seeking...

Read More

New European Pharmacopoeia Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances now available

EDQM 21/01/2021 Strasbourg, France

The new Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 168th session in November 2020. This document provides clear guidance for those involved...

Read More

CEP holders invited to comment on draft monographs published in Pharmeuropa 33.1

EDQM 20/01/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.1. The table below lists the substances affected by these revisions and for which CEPs have been granted. Users are...

Read More

New status of NIBSC (UK) as observer within OCABR network post-Brexit

EDQM 19/01/2021 Strasbourg, France

The Official Control Authority Batch Release (OCABR) Network for human vaccines and medicinal products derived from human blood and plasma and the National Institute of Biological Standards and Control (NIBSC, United Kingdom) have signed a memorandum of understanding (MOU) to renew, post-Brexit,...

Read More

Implementation of the European Pharmacopoeia Supplement 10.5 – Notification for CEP holders

EDQM 18/01/2021 Strasbourg, France

Supplement 10.5 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 July 2021, and to follow the instructions given below. The table at the end of this announcement...

Read More

Adoption of Fritillariae thunbergii bulbus describing alternative quality control test

EDQM 15/01/2021 Strasbourg, France

At its 168th session, the European Phamacopoeia (Ph. Eur.) Commission adopted Fritillariae thunbergii bulbus (2588), the first monograph to describe a test for minimum content of two markers (peimine and peiminine) by high-performance thin layer chromatography (HPTLC).

Read More

EDQM’s ISO 9001:2015 certification maintained

EDQM 13/01/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de...

Read More

Certification monthly report of activities: December 2020

EDQM 12/01/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. December 2020 Certification Monthly Report For more information, access the Certification Database.

Read More

Brexit: End of mutual recognition of Official Control Authority Batch Release between the EU/EEA and the UK

EDQM 08/01/2021 Strasbourg, France

The United Kingdom left the EU on 31 January 2020 and the transition period for Brexit, during which EU legislation still applied, is over as of 31 December 2020. A trade deal for relations after 31 December 2020 has been negotiated between the EU and the UK, but the deal does not include mutual...

Read More

Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments

EDQM 06/01/2021 Strasbourg, France

All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 2021. Users and interested parties are welcome to comment on these drafts. It should be...

Read More

European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26)

EDQM 05/01/2021 Strasbourg, France

At its 168th session in November 2020, the European Pharmacopoeia Commission adopted the new general chapter Contaminant pyrrolizidine alkaloids (2.8.26).

Read More

European Pharmacopoeia Supplement 10.5 now available

EDQM 04/01/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.5 is now available and will be applicable in 39 European countries as of 1 July 2021.

Read More

9 new reference standards and 10 replacement batches released in December 2020

EDQM 04/01/2021 Strasbourg, France

The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 10 replacement batches for Ph. Eur. reference standards in December 2020.

Read More

Certification Monthly Report of Activities: November 2020

EDQM 21/12/2020 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. November 2020 Certification Monthly Report. For more information, access the Certification Database.

Read More

European Paediatric Formulary: Phosphate Oral Solution open for public consultation in issue 3 of Pharmeuropa PaedForm

EDQM 17/12/2020 Strasbourg

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This...

Read More

New method for determination of polar N-nitrosamines in cosmetic products

EDQM 16/12/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published an analytical method for the determination of polar N-nitrosamines in cosmetic products, which was validated within the European Network of Official Cosmetics Control Laboratories (OCCLs). The method is...

Read More

EDQM webinar provides insights on how to implement pharmaceutical care in Europe

EDQM 15/12/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a webinar illustrating the content of Council of Europe Resolution CM/Res(2020)3 on the implementation of pharmaceutical care for the benefit of patients and health services, which aims to support member states...

Read More

EDQM reports presence of allergenic fragrances in cosmetics sold as “perfume-free”

EDQM 15/12/2020 Strasbourg, France

A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that some cosmetic products sold throughout Europe still contain excessive levels of allergy-inducing fragrances. Results showed that 7.7% of samples were non-compliant with legislative requirements due...

Read More

OCABR network for human vaccines welcomes TGA as an observer

EDQM 14/12/2020 Strasbourg, France

The Official Control Authority Batch Release (OCABR) network for human vaccines and the Therapeutic Goods Administration (TGA), Australia have signed a memorandum of understanding (MOU) to increase the exchange and collaboration on common activities related to batch release of human vaccines. ...

Read More

Seven new reference standards available for the analysis of N-nitrosamine impurities

EDQM 14/12/2020 Strasbourg, France

To support the implementation of the newly adopted general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42., previously listed as 2.4.36.), seven reference standards have been established and are available from the European Directorate for the Quality of Medicines...

Read More