Issue 2 of Pharmeuropa PaedForm just released

EDQM 05/10/2020 Strasbourg, France

The EDQM has just released issue 2 of Pharmeuropa PaedForm, in which the third monograph elaborated by the PaedForm Working Party, the draft text for an ethanol-free formulation for Furosemide 2 mg/mL Oral Solution, is published for public consultation prior to its inclusion in the European...

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European Pharmacopoeia Supplement 10.4 now available

EDQM 02/10/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.4 is now available and will be applicable in 39 European countries as of 1 April 2021. This volume is included in the 2021 subscription (10.3, 10.4 and 10.5) to the 10th Edition of the European Pharmacopoeia. Subscriptions for print and/or...

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Pharmeuropa 32.4 just released

EDQM 02/10/2020 Strasbourg, France

All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.4 is 31 December 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: although draft...

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Newsletter Transplant 2020 now available

EDQM 02/10/2020 Strasbourg, France

As health systems worldwide continue to cope with the impact of the COVID-19 pandemic, the EDQM/Council of Europe publishes this year’s issue of the Newsletter Transplant. The timely release of this issue is proof of the EDQM’s dedication to the international medical community and all those...

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New general text on implementation of pharmacopoeial procedures: Ph. Eur. launches public consultation

EDQM 01/10/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general text on the implementation of pharmacopoeial procedures (5.26). The draft text elaborates on the requirement expressed more succinctly in the Ph. Eur. General Notices, according to which “a user must assess whether and...

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European Pharmacopoeia Commission adopts revised dosage form monographs on patches and medicated plasters

EDQM 29/09/2020 Strasbourg, France

At its 167th session in June 2020, the European Pharmacopoeia Commission adopted revised dosage form monographs on transdermal patches, cutaneous patches and medicated plasters, as well as the related test method for dissolution testing. The new version of Patches (1011) now groups together both...

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10 years of co-operation between the European Commission and the EDQM/Council of Europe in the field of blood: key achievements in standard setting

EDQM 28/09/2020 Strasbourg, France

The European Commission (EC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe began formally co-operating in the field of blood in 2010, and later extended the scope of this work to the area of tissues and cells. Their co-operation is...

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Reorganisation of the Romanian Blood System

EDQM 21/09/2020 Strasbourg, France

Call for tenders: International consultants for the provision of consultancy services DEADLINE: midnight (CET), 22 October 2020 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...

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Revision of the Ph. Eur. dosage form monograph on Parenteral preparations (0520) adopted

EDQM 17/09/2020 Strasbourg, France

At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market. The revised...

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10th Edition 10.0-10.2 – Subscriptions now open!

EDQM 11/09/2020 Strasbourg, France

The 2020 subscriptions are now available for sale on our webstore.

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New approach for extraneous agent testing in IVMPs: the EDQM provides further support to its users over the long term

EDQM 11/09/2020 Strasbourg, France

So you missed the webinars on 1 April but have questions about the updated approach to extraneous agent testing in IVMPs? To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the...

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Ph. Eur. Commission adopts revised monograph on Erythropoietin concentrated solution (1316)

EDQM 08/09/2020 Strasbourg, France

The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better...

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10 years of collaboration between the European Commission and the EDQM in the field of blood

EDQM 07/09/2020 Strasbourg, France

Blood transfusion is a life-saving measure: more than 25 million units of blood are transfused per year in Europe and nearly 1 400 blood establishments (BEs) are involved in the supply of blood in Europe on a daily basis. In the 1980s, the emergence of HIV/Aids brought new focus to the importance...

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Update on the review of the CEP application regarding an impurity in the active substance paracetamol

EDQM 03/09/2020 Strasbourg, France

The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA). PCA is a known impurity which may be formed under certain conditions during the...

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5 new reference standards and 21 replacement batches released in August 2020

EDQM 02/09/2020 Strasbourg, France

New releases Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units 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 the availability of: 5 new...

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Nitrosamines risk assessment: update for CEP holders

EDQM 17/08/2020 Strasbourg, France

In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the...

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Pertussis Toxin BRP batch 2 available soon

EDQM 14/08/2020 Strasbourg, France

The Ph. Eur. Commission adopted the replacement batch (batch 2) of the Pertussis Toxin Biological Reference Preparation by correspondence in May 2020. Batch 1 is currently available for regular sales. Batch 2 will be available from the EDQM once the remaining stocks of batch 1 have been...

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New dates and new format for the EDQM/Council of Europe and European Commission (EC) joint conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments”

EDQM 11/08/2020 Strasbourg, France

In light of the ongoing COVID-19 pandemic, the EDQM/Council of Europe and the European Commission (EC) have decided to modify the conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments” to a fully online format that will take place from Tuesday 27 to...

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6 new reference standards and 20 replacement batches released in July 2020

EDQM 05/08/2020 Strasbourg, France

New releases Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Change of price Change of EDQM storage/shipping conditions Current non-availability See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The EDQM announces the...

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Clarification on the acceptability of requests for revision of CEP applications

EDQM 17/08/2020 Strasbourg, France

Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items....

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