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Pharmacopoeial Discussion Group videoconference meetings - April 2021

19/04/2021 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), held videoconferences on 6 November 2020 and on 12 March 2021. WHO (International Pharmacopoeia) participated as...

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Outcome of the 169th session of the European Pharmacopoeia Commission

06/04/2021 Strasbourg, France

The 169th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 March 2021.

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Phasing out animal testing for in-process control of veterinary vaccines

24/03/2021 Strasbourg, France

On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly held by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe),...

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Control of N-nitrosamine impurities in sartans: revision and rapid implementation of five Ph. Eur. monographs

23/02/2021 Strasbourg, France

On 9 July 2020, the EMA’s Committee for Medicinal Products for Human Use (CHMP) published its opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 regarding the detection, management and prevention of the presence of N-nitrosamines in medicinal products for human use (see the report...

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Outcome of the 168th session of the European Pharmacopoeia Commission

04/12/2020 Strasbourg, France

The 168th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 24 and 25 November 2020.

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