Dissolution test in individual monographs on solid oral dosage forms: Your feedback counts!

EDQM 17/01/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is consulting a wide range of stakeholders including industry, National Pharmacopoeia Authorities (NPAs), National Competent Authorities (NCAs) and Official Medicines Control Laboratories (OMCLs) on how the current situation with dissolution...

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Ph. Eur. Monograph for Octreotide (2414) – to be published soon in Ph. Eur. 10.0

EDQM 15/01/2019 Strasbourg, France

The EDQM wishes to inform stakeholders that the monograph for Octreotide (2414) will be published in the 10th Edition of the European Pharmacopoeia and will become effective on 1 January 2020. More information on the Ph. Eur. work programme Visit our KNOWLEDGE database to find more information on...

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Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

EDQM 14/01/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering assay (in vitro cell-based test) for residual pertussis toxin testing in acellular pertussis vaccines, as of next year. The...

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Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods

EDQM 14/01/2019 Strasbourg, France

Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the...

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New general chapter on test for bacterial endotoxins using recombinant factor C. Give your feedback.

EDQM 09/01/2019 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on a new general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor C (rFC). This is not a new topic for the Ph. Eur. which was one of the first pharmacopoeias to refer to rFC, namely in chapter 5.1.10...

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EDQM revised guideline on Content of the dossier for chemical purity and microbiological quality

EDQM 14/12/2018 Strasbourg, France

The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019. Changes included in this revised guideline reflect changes in the regulatory environment since the previous version was implemented in...

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Revised EDQM Guidelines concerning the procedure for ‘Certification of Suitability to the monographs of the European Pharmacopoeia'

EDQM 14/12/2018 Strasbourg, France

Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised and are available.

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Major 3Rs achievement for Official Control Authority Batch Release of human vaccines

EDQM 11/12/2018 Strasbourg, France

In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s protocol...

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EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals

EDQM 06/12/2018 Strasbourg, France

The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in...

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Ph. Eur. Section 3. Materials and containers: clarification of legal status

EDQM 28/11/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in...

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Revised Guideline on requirements for revision/renewal of CEPs: corrected version available

EDQM 20/11/2018 Strasbourg, France

N.B. A corrected version of the guidelines is available where under change 4.II.1.1 c) & e) specific documentation 2 has been deleted and under 4.II.1.2. condition 4 has been deleted since superfluous. The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability...

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Update on the review of CEP applications for sartans

EDQM 19/11/2018 Strasbourg, France

Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of suitability (CEP) R1-CEP 2009-396-Rev 03/Valsartan held by this...

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EDQM laboratory: new NMR accreditation strengthens characterisation capacity for reference standards

EDQM 16/11/2018 Strasbourg, France

The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical competence of...

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Portugal ratifies convention against trafficking in human organs

EDQM 08/11/2018 Strasbourg, France

The Council of Europe Convention against Trafficking in Human Organs was ratified by Portugal on 8 November 2018 and will commence having legal effect in the country as of 1 March 2019. The Convention identifies various activities constituting human organ trafficking which ratifying member states...

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NEW release: 7th edition Guide to the quality and safety of Organs for transplantation

EDQM 06/11/2018 Strasbourg, France

The Organ Guide now in its 7th Edition supports professionals on a practical level to improve the rate of successful and safe organ transplantation. The Organ Guide collates updated information to provide professionals with the most recent advances in the field, as well as technical guidance to...

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Pharmeuropa issue 30.4 is complete. Comments before 31 December 2018

EDQM 30/10/2018 Strasbourg, France

Your input is essential to shape future European Pharmacopoeia (Ph. Eur.) monographs and helps keep texts relevant and fit for purpose.

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Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations

EDQM 30/10/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers...

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Pharmacopoeial discussion group achievements

EDQM 24/10/2018 Strasbourg, France

The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.

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