Supplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018
The European Pharmacopoeia (Ph. Eur.) Commission has launched a public consultation on its proposal to include in its texts 4 plasticisers that can be added to PVC (poly(vinyl chloride)) for manufacturing blood containers and sets for blood transfusions.
On 24 January 2017, the Permanent Representation of the Republic of Moldova to the Council of Europe handed to Mr Thorbjørn Jagland, Secretary General of the Council of Europe, the instrument of accession to the Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989.
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment.
Pending completion of the review of the related substances test published in European Pharmacopoeia 9.0 by the group of experts, and to ensure a continuing supply of erythromycin ethylsuccinate active substance to the European markets, a revised monograph has been prepared and will be effective from 01 May 2017.
The European Pharmacopoeia (Ph. Eur.) Commission adopted 15 new monographs at its 157th Session, which took place in Strasbourg on 21-22 March.
With the publication of Supplement 9.3 of the European Pharmacopoeia, the USB version will be replaced by a downloadable version.
The EDQM will hold an international symposium on 10-11 October 2017 in Strasbourg (France) to present and discuss recent achievements, as well as future perspectives, of the Ph. Eur. in the microbiology field.
During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars.
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product.
The EDQM is pleased to announce that the 2016 issue of Pharmeuropa Bio & Scientific Notes is available online
The Ph. Eur. Commission unanimously decided to grant Japan observer status. This brings to 30 the number of observers, from 6 continents.
The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016.
The EDQM is proud to announce that its Quality Management System has been recognised compliant to the 2015 version of the ISO 9001 standard.
The P4Bio pilot phase came to a successful conclusion at the 156th Session of the European Pharmacopoeia Commission, with the adoption of the monograph for Etanercept (2895).