Transfusion / Legal Framework | News | 22 February 2018 | Strasbourg, France
The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017.
Reference Standard / Chemical reference standard (CRS) | News | 16 February 2018 | Strasbourg, France
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
Reference Standard / Chemical reference standard (CRS) | News | 01 February 2018 | Strasbourg, France
Four new elemental impurity chemical reference standards (CRS) are available in the European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS.
Transplantation / Organ trafficking | News | 31 January 2018 | Strasbourg, France
Armenia has signed the Council of Europe Convention against Trafficking in Human Organs on 24 January 2018. The Convention, which is now signed by 21 countries and ratified by 5, identifies various activities constituting human organ trafficking as criminal offences and will come into force on 1 March 2018.
European Pharmacopoeia / General text/chapter | News | 18 January 2018 | Strasbourg, France
Revision of the Ph. Eur. general chapters on plasticised PVC materials, following the 159th Commission session (November 2017) of the Ph. Eur. Commission.
European Pharmacopoeia / Monograph | News | 14 December 2017 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).
European Pharmacopoeia / Animal testing | News | 08 December 2017 | Strasbourg, France
During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).
European Pharmacopoeia / Ph. Eur. Commission | News | 07 December 2017 | Strasbourg, France
The EDQM wishes to inform stakeholders that the monograph for Etanercept (2895) will be published in the Supplement 9.5 of the European Pharmacopoeia and will become effective on 1 July 2018.
Transplantation / Legal Framework | News | 15 September 2017 | Strasbourg, France
The EDQM has published the 3rd edition of its compendium of all the Council of Europe legal instruments and reports covering ethical, social, scientific and training aspects in the field of donation and transplantation.
European Pharmacopoeia / Pharmacopoeial harmonisation | News | 04 September 2017 | Strasbourg, France
The European Directorate for the Quality of Medicines and HealthCare (EDQM) and the Chinese Pharmacopoeia Commission (ChP) today announced the signing of a new Memorandum of Understanding (MOU) for the next four years.
European Pharmacopoeia / International harmonisation | News | 04 September 2017 | Brasília, Brazil
The European Directorate for the Quality of Medicines and HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, today announced the signing of a Memorandum of Understanding (MOU) on their intention to strengthen relations and promote further co-operation in the field of medicines’ quality and science-based pharmacopoeial standards.
European Pharmacopoeia / Monograph | News | 15 February 2017 | Strasbourg, France
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.
Transfusion / Blood Quality Management system (B-QM) | News | 26 October 2016 | Skopje, "the former Yugoslav Republic of Macedonia"
Recognising the need to support the South Eastern European region in further fostering the key elements of a Blood Quality Management System (B-QM), the EDQM’s B-QM Working Group has conducted a training on Quality Management to meet the needs of blood establishments.