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European Pharmacopoeia / Monograph | News | 12 July 2021 | Strasbourg, France
A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment.
European Pharmacopoeia / Public enquiry | News | 09 July 2021 | Strasbourg, France
The revised general chapter Chemometric methods applied to analytical data (5.21) has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum, for comment.
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 July 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
European Pharmacopoeia / Ph. Eur. Commission | News | 08 July 2021 | Strasbourg, France
At its 170th plenary session on 22-23 June 2021, the European Pharmacopoeia Commission decided to suspend the Gonadotrophin, equine serum, for veterinary use (0719) monograph. This means that as of Supplement 10.8, the monograph in question will no longer be part of the Ph. Eur. but will nonetheless remain on the Ph. Eur. work programme until a final decision can be made concerning its fate.
Reference Standard / Collection & Catalogue | News | 07 July 2021 | Strasbourg, France
The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 22 replacement batches for Ph. Eur. reference standards.
EDQM | News | 06 July 2021 | Strasbourg, France
The 2020 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities, achievements and events.
Products and Services | News | 05 July 2021 | Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.3 is 30 September 2021.
Transplantation / Publications | News | 05 July 2021 | Strasbourg, France
Personal choices regarding parenthood can be affected by disease and other life events that might have an impact on a person’s fertility. Making informed decisions in this highly personal area is of great importance to the health and well-being of individuals everywhere. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has therefore  released a booklet entitled “...
European Pharmacopoeia / Ph. Eur. Commission | News | 02 July 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission held its 170th session on 22 and 23 June 2021. As the decision-making body of the Ph. Eur., the Commission adopted 69 texts that will be published in Ph. Eur. Supplement 10.8 and be effective as of 1 July 2022.
Certification of suitability (CEP) / Inspection | News | 02 July 2021 | Strasbourg, France
Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions  – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS).
European Pharmacopoeia / Animal testing | News | 29 June 2021 | Strasbourg, France
The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been published in Pharmeuropa Bio & Scientific Notes.
EDQM / All activities | News | 28 June 2021 | Strasbourg, France
The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021.
European Pharmacopoeia / Animal testing | News | 28 June 2021 | Strasbourg, France
At its 170th session in June 2021, the European Pharmacopoeia (Ph. Eur.) Commission took the decision to engage on a path that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., within approximately 5 years.
News | 27 June 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.6 is now available and will be applicable in 39 European countries as of 1 January 2022.
European Pharmacopoeia / International harmonisation | News | 24 June 2021 | Strasbourg, France
At its November 2020 meeting, the ICH Assembly approved the proposal made by the PDG (Pharmacopoeial Discussion Group) on how to include the pharmacopoeias of the non-Founding ICH Regulatory Members in the maintenance of the ICH Q4B Annexes. The expansion of ICH membership provides an excellent opportunity to further promote the global convergence of pharmacopoeial quality standards, through the...