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The European Pharmacopoeia Commission elects its two new Vice Chairs
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....
Certification monthly report of activities: End of July 2022
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.
EDQM closure Monday 15 August 2022 and IT maintenance Saturday 13 to Monday 15 August 2022
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...
Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)
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...
Ph. Eur. Commission establishes a new working party on mRNA vaccines
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...
3 new Ph. Eur. reference standards and 23 replacement batches released in July 2022
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...
General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition
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...
Stakeholder consultation – Draft guidelines for medication review
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,...
Call for experts: join the Ph. Eur. network
Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products
Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online
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...
15 replacement batches released in June 2022
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...
Draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells
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...
EDQM publishes 8th edition of the Guide to the quality and safety of organs for transplantation
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...
Certification monthly report of activities: End of June 2022
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.
What’s new for homoeopathic preparations at European level?
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...
EDQM closure Thursday 14 July 2022
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.
Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022
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...
New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication
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...