Transfusion / Projects | News | 28 September 2020 | Strasbourg, France
The European Commission (EC) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe began formally co-operating in the field of blood in 2010, and later extended the scope of this work to the area of tissues and cells. Their co-operation is contributing to laying the groundwork for a harmonised governance framework for substances of human origin...
Transfusion / Projects | News | 21 September 2020 | Strasbourg, France
The EDQM/Council of Europe will implement the “Reorganisation of the Romanian Blood System” project. The project aims to support Romania in setting up a fit-for-purpose and efficient blood transfusion system aligned with European Union and EDQM standards. The EDQM is therefore seeking experienced professionals in the field of blood transfusion to provide consultancy services in order to: develop...
European Pharmacopoeia / Ph. Eur. Commission | News | 17 September 2020 | Strasbourg, France
At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market.
European Pharmacopoeia / Medicine for veterinary use | News | 11 September 2020 | Strasbourg, France
So you missed the webinars on 1 April but have questions about the updated approach to extraneous agent testing in IVMPs? To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the content of the training webinars which took place on 1 April 2020.
European Pharmacopoeia / Monograph | News | 08 September 2020 | Strasbourg, France
The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of these substances, and...
Transfusion / General | News | 07 September 2020 | Strasbourg, France
Blood transfusion is a life-saving measure: more than 25 million units of blood are transfused per year in Europe and nearly 1 400 blood establishments (BEs) are involved in the supply of blood in Europe on a daily basis.
Certification of suitability (CEP) | News | 03 September 2020 | Strasbourg, France
The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with the impurity 4-chloroaniline (PCA).
Products and Services | News | 02 September 2020 | Strasbourg, France
The EDQM announces the availability of 5 new reference standards and 21 replacement batches for Ph. Eur. reference standards, released in August 2020
Certification of suitability (CEP) / Nitrosamines | News | 17 August 2020 | Strasbourg, France
In October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regard to potential nitrosamine formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites.
EDQM / All activities | News | 17 August 2020 | Strasbourg, France
The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.
Reference Standard / Biological reference preparation (BRP) | News | 14 August 2020 | Strasbourg, France
The Ph. Eur. Commission adopted the replacement batch (batch 2) of the Pertussis Toxin Biological Reference Preparation by correspondence in May 2020.
Transfusion / Blood Quality Management system (B-QM) | News | 11 August 2020 | Strasbourg, France
In light of the ongoing COVID-19 pandemic, the EDQM/Council of Europe and the European Commission (EC) have decided to modify the conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments” to a fully online format that will take place from Tuesday 27 to Thursday 29 October 2020.
Products and Services | News | 05 August 2020 | Strasbourg, France
6 new reference standards and 20 replacement batches released in July 2020 The EDQM announces the availability of: 6 new European Pharmacopoeia (Ph. Eur.) reference standards and 20 replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 July 2020 | Strasbourg, France
Supplement 10.3 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2021, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP revision | News | 21 July 2020 | Strasbourg, France
Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items.