Organ transplantation: Committee warns against Global Kidney Exchange programme

EDQM 23/04/2018 Strasbourg, France

The Council of Europe Committee on Organ Transplantation (CD-P-TO), with the support of the Council of Europe Committee on Bioethics (DH-BIO), has issued a recommendation to the Member States of the Council of Europe, as well as health authorities, hospitals and professionals not to engage in...

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Ph. Eur. Commission reinstates its Gene Therapy Products (GTP) Working Party

EDQM 17/04/2018 Strasbourg, France

The Ph. Eur. Commission decided at its 160th session of March 2018 to reactivate its dedicated GTP Working Party and task it with the revision of general chapter “5.14 Gene transfer medicinal products for human use”. This chapter, which was last revised in 2008, now needs to take into account...

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Live Biotherapeutic Products (LBPs): unprecedented quality requirements by the Ph. Eur. Commission

EDQM 16/04/2018 Strasbourg, France

At its 160th Session, the European Pharmacopoeia (Ph. Eur.) Commission achieved an important milestone in the setting of quality requirements for Live Biotherapeutic Products (LBPs) with the adoption of quality standards for LBPs for human use: a general monograph on Live biotherapeutic products...

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Ph. Eur. on acellular pertussis vaccines: Histamine Sensitisation Test proposed for replacement

EDQM 13/04/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is seeking public feedback on its proposal to replace the Histamine sensitisation test in mice (HIST) with a standardised CHO cell clustering assay for residual pertussis toxin testing, in general chapter 2.6.33 Residual pertussis toxin and...

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Revised: Human vaccines guidelines with aP components

EDQM 09/04/2018 Strasbourg, France

  The human Official Control Authority Batch Release (OCABR) Network has adopted revisions to 9 human vaccine guidelines for vaccines containing acellular pertussis components. The update removes the requirement for the Official Medicines Control Laboratories (OMCLs) to perform the histamine...

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Revised: “Validation of Computerised Systems” Guideline

EDQM 09/04/2018 Strasbourg, France

Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have...

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The Ph. Eur. revises its general chapter on Infrared Absorption Spectrophotometry

EDQM 06/04/2018 Strasbourg, France

At its 160th session (March 2018) the Ph. Eur. Commission adopted a new version of one of its major general methods, which has undergone extensive revision. The chapter on Infrared Absorption Spectrophotometry (2.2.24) is one of the original cornerstones of pharmacopoeial testing, referenced in...

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Outcome of the 160th Session of the European Pharmacopoeia Commission

EDQM 05/04/2018 Strasbourg, France

At its 160th Session which took place in Strasbourg on 20-21 March 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 19 new monographs, 3 new chapters, 51 revised monographs and 15 revised chapters, including: six monographs elaborated under the P4 procedure, Atazanavir sulfate...

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European Pharmacopoeia Reference Standards recently released in March 2018

EDQM 03/04/2018 Strasbourg, France

New Ph. Eur. Reference Standards Y0001954 N-acyl-phosphatidylethanolamine from Soya bean Y0001981 Mometasone furoate monohydrate Y0001961 Tigecycline Y0001988 Succinic acid Access the full list here   Content of the European Pharmacopoeia catalogue The catalogue of the European Pharmacopoeia (Ph....

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Rapid implementation of the monograph Products of fermentation (1468)

EDQM 03/04/2018 Strasbourg, France

Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468). The implementation date for the revised monograph was 1 April 2018....

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New Automated Dose Dispensing (ADD) Guidelines

EDQM 15/03/2018 Strasbourg, France

The EDQM has issued its Guidelines on ‘Best Practice for the Automated Dose Dispensing (ADD) Process and Care and Safety of Patients’. ADD is an automated process, which allows one or more medicinal products to be dispensed into a container/pouch for a patient to take at a particular date and...

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European Pharmacopoeia Reference Standards released in February 2018

EDQM 12/03/2018 Strasbourg, France

New Ph. Eur. Reference Standards - February Y0001973 Lacosamide for system suitability Y0001983 Hyoscine butylbromide for system suitability Y0001947 Paeonol Y0001980 Folic acid for impurity I identification Y0001982 Lacosamide Y0001979 Folic acid for system suitability Y0001974 Codeine...

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Haemophilia: new standards for patient care in Council of Europe Resolution

EDQM 22/02/2018 Strasbourg, France

The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad...

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New versatile reference standard for equipment qualification

EDQM 16/02/2018 Strasbourg, France

The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018. The new reference standard (RS) comes...

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New elemental impurities reference standards: lead, cadmium, mercury and arsenic

EDQM 01/02/2018 Strasbourg, France

Four new elemental impurity chemical reference standards (CRS) are available in the European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS. These elements occurring in nature are amongst the greatest potential sources of elemental...

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Armenia signs Convention against Trafficking in Human Organs

EDQM 31/01/2018 Strasbourg, France

Armenia signed the Council of Europe Convention against Trafficking in Human Organs on 24 January 2018. The Convention, which is now signed by 21 countries and ratified by 5, identifies various activities constituting human organ trafficking as criminal offences and will come into force on 1...

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The Ph. Eur. revised its general chapters on plasticised PVC materials

EDQM 18/01/2018 Strasbourg, France

At its 159th Commission session (November 2017) the Ph. Eur. Commission adopted the following revised general chapters: - 3.1.1.1/90001. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components; - 3.1.1.2/90002. Materials based on plasticised...

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New monograph for Infliximab concentrated solution: the first monograph on a monoclonal antibody in the Ph. Eur.

EDQM 14/12/2017 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).

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EDQM and ANVISA sign co-operation agreement to strengthen quality of medicines

EDQM 04/09/2017 Brasília, Brazil

The European Directorate for the Quality of Medicines and HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, today announced the signing of a Memorandum of Understanding (MOU) on their intention to strengthen relations and promote further co-operation in the field of...

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