Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments

EDQM 06/01/2021 Strasbourg, France

All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 2021. Users and interested parties are welcome to comment on these drafts. It should be...

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European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26)

EDQM 05/01/2021 Strasbourg, France

At its 168th session in November 2020, the European Pharmacopoeia Commission adopted the new general chapter Contaminant pyrrolizidine alkaloids (2.8.26).

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European Pharmacopoeia Supplement 10.5 now available

EDQM 04/01/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.5 is now available and will be applicable in 39 European countries as of 1 July 2021.

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European Paediatric Formulary: Phosphate Oral Solution open for public consultation in issue 3 of Pharmeuropa PaedForm

EDQM 17/12/2020 Strasbourg

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This...

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Nitrosamines – Update from the CEP procedure

EDQM 16/12/2020 Strasbourg, France

In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020...

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New policy for dissolution and disintegration testing in Ph. Eur. monographs

EDQM 10/12/2020 Strasbourg, France

Over the last few years, the European Pharmacopoeia (Ph. Eur.) has been elaborating monographs on medicinal products containing chemically defined active substances, applicable to immediate-release solid dosage forms (tablets, capsules). These monographs include a mandatory test for dissolution...

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Ph. Eur. Commission adopts a new general chapter for the analysis of N-nitrosamine impurities

EDQM 07/12/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42, previously listed as 2.4.36). The general chapter should be seen as an analytical toolbox that proposes three procedures relying on more or...

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Outcome of the 168th session of the European Pharmacopoeia Commission

EDQM 04/12/2020 Strasbourg, France

The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020. At this session, the Commission adopted 114 texts for publication in Ph. Eur. Supplement 10.6, including 101 revised texts and the following 13 new texts: 4 general chapters: Particulate...

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EDQM releases updated European Pharmacopoeia vaccines package for COVID-19 vaccine developers

EDQM 23/11/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released an updated set of pharmacopoeial quality standards for vaccines. Originally published in June 2020, the package now includes a further 17 texts on analytical methods which are referenced in the recently...

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PDG Videoconference meeting, 22-23 September 2020

EDQM 14/10/2020 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020, with WHO attending as observer. Due to the COVID-19 pandemic, the...

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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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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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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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Pharmeuropa 32.3 just released

EDQM 15/07/2020 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 32.3 is 30 September 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: although draft...

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Last chance to comment: analysis of N-nitrosamine impurities

EDQM 10/07/2020 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020. Given the exceptional circumstances due...

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