Certification of suitability (CEP) / Procedure of certification (general) | Guideline | 17 July 2018 | Strasbourg, France
The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
Anti-Counterfeiting activities / Counterfeit/illegal medical products | News | 16 July 2018 | Strasbourg, France
This project will favour better interaction between the analytical and enforcement actors involved in the fight against falsified medicines and medical devices.
Products and Services | News | 13 July 2018 | Strasbourg, France
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.
European Pharmacopoeia / Announcements | News | 10 July 2018 | Strasbourg, France
The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.
European Pharmacopoeia / Monograph | News | 10 July 2018 | Strasbourg, France
The new monograph on Sulfobutylbetadex sodium (2804) was published in Supplement 9.6 of the European Pharmacopoeia.
EDQM / All activities | Report | 02 July 2018 | Strasbourg, France
The EDQM has released its 2017 Annual Report providing an overview of its accomplishments. Among the major highlights for the past year, the European Pharmacopoeia (Ph. Eur.) Commission kept on ensuring that the monographs and texts of the Ph.Eur. stay abreast of scientific and technological progress and achieved considerable progress in the field of biotherapeutic products. For example, the...
European Pharmacopoeia / Ph. Eur. Commission | News | 29 June 2018 | Strasbourg, France
At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and 7 revised chapters.
European Pharmacopoeia / Biologicals | News | 29 June 2018 | Strasbourg, France
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...
European Pharmacopoeia / Announcements | News | 20 June 2018 | Strasbourg, France
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.
Transfusion / Donations Campaigns & World Blood Donor Day (WBDD) | News | 13 June 2018 | Strasbourg, France
June 14 is World Blood Donor Day! Let’s celebrate together! Giving blood saves lives. Every year more than 25 million blood transfusions are performed in Europe.
EDQM | News | 12 June 2018 | Metz, France
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.
Products and Services | News | 07 June 2018 | Strasbourg, France
3 new Ph. Eur. Reference Standards (RS) were released in May 2018
European Pharmacopoeia / Monograph | News | 05 June 2018 | Strasbourg, France
The monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur.
European network of OMCLs / General European OMCLs Network activities | News | 25 May 2018 | Strasbourg, France
The Annual Meeting of the Official Medicines Control Laboratories (OMCLs) took place on 14-18 May in Sarajevo (Bosnia and Herzegovina). It was attended by 230 participants from 38 countries, representing 65 official laboratories and including a representative of the OMCL Network, the Taiwan Food and Drug Administration, which just joined the Network as an associated member.
European Pharmacopoeia / General text/chapter | News | 23 May 2018 | Strasbourg, France
Following up on issues that were reported with the revised limit test on Arsenic (method A, 2.4.2) published in Supplement 9.4., the Ph. Eur. Commission decided to revert back to the previous version of the chapter 2.4.2., until further notice.