Call for experts: join the Ph. Eur. network

EDQM 10/08/2022 Strasbourg, France

Pharmaceutical analytical procedures related to quality control methods for antibiotics

Read More

Join the EDQM as Head of the Communications and Events Division

EDQM 10/08/2022 Strasbourg, France

Come shape the future of public health and medicines with us!

Read More

The European Pharmacopoeia Commission elects its two new Vice Chairs

EDQM 10/08/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is pleased to announce the nomination of two new Vice Chairs, elected at its 173rd session held on 22 and 23 June 2022. Dr Eugenia Cogliandro (first Vice Chair) and Dr Marija Malesevic (second Vice Chair), replace outgoing Vice Chairs Prof. S....

Read More

Certification monthly report of activities: End of July 2022

EDQM 08/08/2022 Strasbourg, France

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

Read More

EDQM closure Monday 15 August 2022 and IT maintenance Saturday 13 to Monday 15 August 2022

EDQM 08/08/2022 Strasbourg and Metz, France

Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Monday 15 August 2022. In addition, maintenance work impacting the EDQM network will also be carried out starting Saturday 13 August, until the evening of Monday 15...

Read More

Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)

EDQM 04/08/2022 Strasbourg, France

The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required...

Read More

Ph. Eur. Commission establishes a new working party on mRNA vaccines

EDQM 03/08/2022 Strasbourg, France

At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...

Read More

3 new Ph. Eur. reference standards and 23 replacement batches released in July 2022

EDQM 01/08/2022 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information 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...

Read More

General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition

EDQM 27/07/2022 Strasbourg, France

General chapter 2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the...

Read More

Stakeholder consultation – Draft guidelines for medication review

EDQM 26/07/2022 Strasbourg, France

From 20 July to 23 September 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking the opinions of stakeholders on its draft guidelines for medication review. This consultation targets international organisations active in public health and social matters,...

Read More

Call for experts: join the Ph. Eur. network

EDQM 18/07/2022 Strasbourg, France

Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products

Read More

Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online

EDQM 18/07/2022 Strasbourg, France

Following the adoption of batch 4 of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for human immunoglobulin for electrophoresis by the Ph. Eur. Commission, the outcome of the establishment study has been published in Pharmeuropa Bio & Scientific Notes, a freely...

Read More

15 replacement batches released in June 2022

EDQM 15/07/2022 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information 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...

Read More

Draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells

EDQM 15/07/2022 Strasbourg, France

On 14 July 2022, the European Union (EU) Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC), in which the EU Commission proposes to leverage on the technical standards and proven expertise of the European Centre for Disease Prevention and...

Read More

EDQM publishes 8th edition of the Guide to the quality and safety of organs for transplantation

EDQM 13/07/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 8th edition of the Guide to the quality and safety of organs for transplantation. The updated guide provides practical guidance to all professionals in the field, as well as technical guidance to...

Read More

Certification monthly report of activities: End of June 2022

EDQM 13/07/2022 Strasbourg, France

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

Read More

What’s new for homoeopathic preparations at European level?

EDQM 11/07/2022 Strasbourg, France

First revision of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022) As announced in the press release dated 11 April 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved the revised version of the Guide for the elaboration of monographs on...

Read More

EDQM closure Thursday 14 July 2022

EDQM 11/07/2022 Strasbourg, France

Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Thursday 14 July 2022. Normal office hours will resume on Friday 15 July 2022.

Read More

Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022

EDQM 05/07/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...

Read More

New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication

EDQM 07/07/2022 Strasbourg, France

At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a...

Read More