News | 17 September 2020 | Strasbourg, France
At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market.
News | 11 September 2020 | Strasbourg, France
So you missed the webinars on 1 April but have questions about the updated approach to extraneous agent testing in IVMPs? To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the content of the training webinars which took place on 1 April 2020.
News | 08 September 2020 | Strasbourg, France
The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of these substances, and...
News | 07 September 2020 | Strasbourg, France
Blood transfusion is a life-saving measure: more than 25 million units of blood are transfused per year in Europe and nearly 1 400 blood establishments (BEs) are involved in the supply of blood in Europe on a daily basis.
News | 03 September 2020 | Strasbourg, France
The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).
News | 02 September 2020 | Strasbourg, France
The EDQM announces the availability of 5 new reference standards and 21 replacement batches for Ph. Eur. reference standards, released in August 2020