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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EDQM and EC build on 10 years of co-operation to support a more sustainable blood supply and resilient blood sector

EDQM 08/12/2020 Strasbourg, France

A conference celebrating 10 years of co-operation between the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) in the field of blood transfusion shed light on the challenges faced by blood establishments (BEs) in securing sustainable blood...

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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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12 new reference standards and 9 replacement batches released in November 2020

EDQM 02/12/2020 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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New conditions for ordering Ph. Eur. RS R0250000 – Residual solvent solution class 1 CRS

EDQM 30/11/2020 Strasbourg, France

Starting 1 January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS. Reference standard R0250000 – Residual solvent solution class 1 CRS contains 2 controlled substances (Carbon tetrachloride and 1,1,1–Trichloroethane). Regulation (EC) No....

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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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End-of-year closure: EDQM order and shipment deadlines

EDQM 18/11/2020 Strasbourg, France

Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the EDQM offices from 23 December 2020 (12 noon CET) to 4 January 2021 (8 a.m. CET). See also: Ph. Eur. Reference Standards Catalogue EDQM Webstore Reference Standards...

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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

EDQM 12/11/2020 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent...

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8 new reference standards and 24 replacement batches released in October 2020

EDQM 09/11/2020 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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CEP holders invited to comment on draft monographs published in Pharmeuropa 32.4

EDQM 05/11/2020 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 32.4. The table below lists the substances affected by these revisions and for which CEPs have been granted. Users are...

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Ensuring the availability of quality standards for medicines in the context of the COVID-19 pandemic

EDQM 30/10/2020 Strasbourg, France

In the context of the COVID-19 pandemic, the availability of quality medicines is more important than ever. Unfortunately, since the start of the sanitary crisis, shortages of medicines have increased around the world, and notably of those to treat or alleviate COVID-19 symptoms or used in...

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Committee of the Parties of the Council of Europe Convention against Trafficking in Human Organs to be convened following Switzerland’s ratification

EDQM 27/10/2020 Strasbourg, France

On 21 October 2020, Switzerland ratified the Council of Europe Convention against Trafficking in Human Organs, also known as the Santiago de Compostela Convention. The convention will enter into force in the country as of 1 February 2021. This legal instrument identifies various activities...

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New Council of Europe resolution to strengthen safety of food contact materials

EDQM 19/10/2020 Strasbourg, France

The Committee of Ministers of the Council of Europe1 has adopted a new resolution2 on the safety and quality of materials and articles for contact with food. This instrument is expected to improve the protection of consumers from contaminants (metals, antioxidants, stabilisers, colorants,...

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Products and extemporaneous preparation of paediatric formulations that may be useful in the treatment of COVID-19

EDQM 16/10/2020 Strasbourg, France

During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication are currently ongoing and medicinal products are also being used experimentally in clinical practice. Reference is made to the...

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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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EODD, 10 October 2020: take a minute to think about organ, tissue and cell donation

EDQM 08/10/2020 Strasbourg, France

Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the...

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New Council of Europe guidance on the protection of haematopoietic progenitor cell donors

EDQM 08/10/2020 Strasbourg, France

The Committee of Ministers of the Council of Europe has adopted a recommendation1 calling on member states to take measures to protect the health of donors of haematopoietic progenitor cells (HPCs). These cells are used as a lifesaving treatment for patients with severe blood diseases and are the...

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Two new Council of Europe recommendations on quality and safety standards for organ, tissue and cell transplantation in Europe

EDQM 08/10/2020 Strasbourg, France

The Committee of Ministers of the Council of Europe has adopted two new recommendations,1 calling on member states to ensure that quality and safety standards for the donation and transplantation or human application of organs, tissues and cells are respected in accordance with the technical...

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10 new reference standards and 22 replacement batches released in September 2020

EDQM 06/10/2020 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: 10 new...

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