This new edition consists of updated and easy to use information on organ transplantation, and guidance to all professionals involved in donation and transplantation of organs.
On 1 August 2016, Belgium became the eighth state to ratify the Council of Europe Convention on the counterfeiting of medical products and similar crimes...
The last monthly activity report for the Certification of Substances Division (DCEP) is now available for July 2016.
A document has been prepared to provide guidance on the implementation of ICH Q3D on elemental impurities in the context of Certificates of Suitability (CEP).
The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised.
It has been noticed that the monograph on polysorbate 80 (0428) contains an error in the expression used to calculate the concentration of dioxan, i.e. a factor 1000 is missing from the numerator.
Do not miss this opportunity to interact with key representatives from the Chinese and European Pharmacopoeias!
The EDQM is preparing its next international conference on its Certification Procedure, which will take place in 2017 (final date and European venue to be confirmed in the coming weeks).
Pharmeuropa contains draft pharmacopoeial texts for which the European Pharmacopoeia Commission is seeking comment. If you would like to receive e-mail alerts when an issue is complete, please register for Pharmeuropa online. Pharmeuropa issue 28.3 is now complete.
During its 155th session, which took place on 21-22 June, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Torbjörn Arvidsson (Sweden) and Dr Hilda Köszegi Szalai (Hungary) as its first and second Vice-chair, respectively, for a term of three years. The Commission also adopted nine new monographs and one new general chapter as well as 46 revised monographs, 15 revised general...
The ultimate goals of the two new Resolutions are to promote public health through the harmonisation of requirements for medicinal preparations, support health professionals with appropriate guidance to prevent risk of health damage caused by drug preparation errors, and ensure that patient needs are fully met.
The EDQM was formally welcomed as an Observer to the International Council for Harmonisation (ICH) at the ICH’s meeting in Lisbon, Portugal, on 11-16 June 2016. The EDQM was one of 14 new Observers and 2 new Members representing regulatory authorities, regional health initiatives and pharmaceutical industry that were welcomed in Lisbon by the ICH, which provides a global platform for...
During its 155th Session, held in Strasbourg on 21-22 June 2016, the European Pharmacopoeia Commission adopted a revision of the general chapter Monocyte-activation test (2.6.30) in order to make it more widely useable by stakeholders and thus facilitate a reduction in testing on live animals.
To date, 29 of the 36 General Chapters and 49 of the 67 excipient monographs on the current work programme have been harmonised. Sign-offs at this meeting include a new monograph on...
The General European OMCL Network (GEON) successfully met increasing market demand in 2015 for independent experimental testing of the quality of medicines, blood-derived medicinal products and vaccines in Europe.