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Lead solution CRS , cadmium solution CRS, mercury solution CRS and arsenic solution CRS have been recently added in EDQM RS Portfolio. These “Class 1” elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for pharmaceutical use and require evaluation during the risk assessment across all potential sources of...

The catalogue of the European Pharmacopoeia (Ph. Eur.) offers a portfolio of more than 2 800 reference standards. It is updated on a daily basis and gives access to all the Ph. Eur. reference standards and to Batch Validity Statement (BVS), Safety Data Sheets, leaflets.

The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6 of the European Pharmacopoeia.

The new biotherapeutics section on the EDQM website summarises Ph. Eur. Commission activities and achievements in this field. In addition to clarification of the role of Ph. Eur. monographs in the biosimilars regulatory pathway, it describes the recently concluded P4-BIO pilot phase and the ongoing pilot phase on monoclonal antibodies (“MAB pilot phase”), explaining the strategy followed by the...

To celebrate the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th anniversary of the establishment of the European Network of Official Medicines Control Laboratories (OMCLs) and the Certification of suitability to the monographs of the European Pharmacopoeia procedure, the EDQM is organising an international conference in Strasbourg (France) on 19-20 June 2019.

The first stone of a new secondary site for the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM) has been laid. The new site will be used to store the EDQM’s portfolio of over 3 000 pharmaceutical reference standards, as an addition to those already in stock at the main building in Strasbourg.