9 new reference standards and 22 replacement batches released in June 2021

EDQM 07/07/2021 Strasbourg, France

The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 22 replacement batches for Ph. Eur. reference standards.

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Highlights of 2020 – EDQM annual report now available

EDQM 06/07/2021 Strasbourg, France

The 2020 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities, achievements and events. While the year 2020 will long be remembered for the COVID-19 pandemic almost bringing the world to a...

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EDQM fertility preservation guide now available

EDQM 05/07/2021 Strasbourg, France

Personal choices regarding parenthood can be affected by disease and other life events that might have an impact on a person’s fertility. Making informed decisions in this highly personal area is of great importance to the health and well-being of individuals everywhere. The European Directorate...

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Pharmeuropa 33.3 just released

EDQM 05/07/2021 Strasbourg, France

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.3 is 30 September 2021. Users and interested parties are welcome to comment on these drafts. It...

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EDQM “RTEMIS” pilot project: real-time remote GMP inspections of API manufacturers

EDQM 02/07/2021 Strasbourg, France

Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a...

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Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes

EDQM 29/06/2021 Strasbourg, France

The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been...

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The Council of Europe appoints future EDQM Director

EDQM 28/06/2021 Strasbourg, France

The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021. Petra Dörr comes to the EDQM with more than 25 years of...

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European Pharmacopoeia to put an end to the rabbit pyrogen test

EDQM 28/06/2021 Strasbourg, France

At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years. The Ph. Eur. test for pyrogens (general...

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European Pharmacopoeia Supplement 10.6 now available

EDQM 27/06/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.6 is now available and will be applicable in 39 European countries as of 1 January 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the European Pharmacopoeia. Subscriptions for print and/or...

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PDG’s efforts to engage other ICH pharmacopoeias in the Q4B Annexes maintenance process

EDQM 24/06/2021 Strasbourg, France

At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent...

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NEW: As of July 2021, EDQM reference spectra will be sent exclusively by email in PDF format

EDQM 22/06/2021 Strasbourg, France

Please be advised that as of July 2021, EDQM reference spectra will be sent exclusively by email in PDF format and no longer in paper format by courier.

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The Eurasian Economic Commission and the EDQM agree to extend and strengthen international collaboration in the circulation of medicines

EDQM 15/06/2021 Strasbourg, France

On 26 May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Eurasian Economic Commission (EEC) signed a memorandum of understanding.

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June 14 is World Blood Donor Day! Give blood and keep the world beating

EDQM 14/06/2021 Strasbourg, France

At every moment, someone, somewhere, needs blood. 
Blood components – plasma, red cells and platelets – are routinely used to save patients’ lives during surgery, after an accident or during acute illnesses, such as cancer or haemophilia. Regular blood donations are needed to give...

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New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP

EDQM 11/06/2021 Strasbourg, France

An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...

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Certification monthly report of activities: May 2021

EDQM 08/06/2021 Strasbourg, France

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

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Sign up today! EDQM Virtual Training Programme - Modules on Ph. Eur., RS & CEP Procedure

EDQM 07/06/2021 online

This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia...

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2 new reference standards and 20 replacement batches released in May 2021

EDQM 04/06/2021 Strasbourg, France

The EDQM announces the availability of 2 new European Pharmacopoeia (Ph. Eur.) reference standards and 20 replacement batches for Ph. Eur. reference standards.
 

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2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation

EDQM 20/05/2021 Strasbourg, France

A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition to applying to solutions for dialysis, the European Pharmacopoeia requires this test to be...

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EDQM releases guidance on paper and board materials and articles for food contact

EDQM 19/05/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the first edition of the technical guide entitled “Paper and board used in food contact materials and articles”, following the October 2020 adoption of the resolution on the safety and quality of...

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Revision of the document “Implementation of policy on elemental impurities in the Certification Procedure”

EDQM 19/05/2021 Strasbourg, France

The EDQM document “Implementation of policy on elemental impurities in the Certification Procedure” has been revised to reflect that risk assessments have to be performed and suitable controls for elemental impurities should be implemented using the principles of risk management for substances...

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