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.