1 new reference standard and 14 replacement batches released in March 2021

EDQM 07/04/2021 Strasbourg, France

The EDQM announces the availability of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 14 replacement batches for Ph. Eur. reference standards.

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Outcome of the 169th session of the European Pharmacopoeia Commission

EDQM 06/04/2021 Strasbourg, France

The 169th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 March 2021. At this session, the Commission adopted 68 texts for publication in Ph. Eur. Supplement 10.7, including the following 9 new texts: 8 individual monographs: Nebivolol hydrochloride (2575);...

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Adoption of the revised Raman spectroscopy chapter

EDQM 31/03/2021 Strasbourg, France

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Their interfaces are user-friendly and they can provide essential information...

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EDQM affiliation and conflict of interest statement

EDQM 30/03/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has been informed that certain commercial providers of reference standards claim their key staff are former senior employees of the EDQM. To the knowledge of the EDQM, this is not the case. The EDQM is independent from any...

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Phasing out animal testing for in-process control of veterinary vaccines: Clostridium septicum as a proof of concept

EDQM 24/03/2021 Strasbourg, France

On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe), the...

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European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021

EDQM 17/03/2021 Strasbourg, France

The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were...

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General chapter 2.5.42. N-Nitrosamines in active substances and revised sartan monographs

EDQM 17/03/2021 Strasbourg, France

In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was...

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Certification monthly report of activities: February 2021

EDQM 12/03/2021 Strasbourg, France

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

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How CEP holders can avoid the rejection of notifications

EDQM 11/03/2021 Strasbourg, France

In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...

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Data protection in the blood sector: challenges for European blood establishments

EDQM 09/03/2021 Strasbourg, France

A live, interactive webinar held on 17 February 2021 addressed the challenges that data protection presents for blood establishments (BEs), as a follow-up to the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Quality Management (B-QM) conference “Keeping up with...

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7 new reference standards and 30 replacement batches released in February 2021

EDQM 04/03/2021 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 EDQM announces...

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Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation

EDQM 01/03/2021 Strasbourg, France

The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the...

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“The collection, testing and use of blood and blood components in Europe”, 2016 report, now available for download from the EDQM

EDQM 24/02/2021 Strasbourg, France

The European Committee on Blood Transfusion (CD-P-TS) has approved the publication of the 2016 edition of “The collection, testing and use of blood and blood components in Europe”. In total, 28 Council of Europe member states,[1] representing some 430 million inhabitants, reported annual data for...

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Webinar “Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how far have we come, how far have we to go?”

EDQM 22/02/2021 Strasbourg, France

This webinar is intended to support users and stakeholders in the swift implementation of the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C by answering the following questions: What conditions need to be met? What needs to be verified? Is validation...

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Certification monthly report of activities: January 2021

EDQM 09/02/2021 Strasbourg, France

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

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Updates of Ph. Eur. dosage form monographs and general chapters – Users invited to comment in Pharmeuropa 33.1

EDQM 08/02/2021 Strasbourg, France

The European Pharmacopeia (Ph. Eur.) regularly updates its dosage form monographs and related general chapters to ensure that they continue to reflect current practices and scientific progress.

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Ph. Eur. Supplement 10.6: updated dosage form monographs and general chapters

EDQM 04/02/2021 Strasbourg, France

At its 168th session in November 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted revised versions of three dosage form monographs and two related general chapters, together with one new general chapter. While the revised texts cover a large number of medicinal products including...

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5 new reference standards and 17 replacement batches released in January 2021

EDQM 03/02/2021 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 EDQM announces...

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Implementation of risk assessment requirements to control elemental impurities in substances for veterinary use

EDQM 26/01/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) general monograph Pharmaceutical preparations (2619) requires manufacturers of products outside the scope of general chapter 5.20 to control the levels of elemental impurities in products using the principles of risk management. As of 1 January 2021, this...

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COVID-19 and vaccines: Equitable access to vaccination must be ensured

EDQM 22/01/2021 Strasbourg, France

How can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of recommendations. First, strategies should be put in place to avoid generating discrimination due to material aspects, such as...

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