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EDQM and EU Commission discuss improving plasma supply management and donor protection

05/02/2019 Strasbourg, France

The EDQM and the European Commission (EC) brought together stakeholders involved in the field of plasma to discuss ways forward for improving plasma supply management and donor protection, during a symposium organised in Strasbourg on 29 and 30 January 2019.

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

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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Outcome of the 162nd Session of the European Pharmacopoeia Commission

30/11/2018 Strasbourg, France

At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts.

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Modification of the structure of Section 3. Materials and containers for the 10th Edition of the Ph. Eur.

29/11/2018 Strasbourg, France

The European Pharmacopeia (Ph. Eur.) includes a Section 3. on materials for containers (Subsection 3.1) and containers (Subsection 3.2). For historical reasons, the general chapters of this Section 3. include texts on primary packaging, as well as on medical devices. To clarify the...

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Public Consultation for Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)

06/11/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on two major texts for the testing of parenteral drug products. The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for...

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