Certification of suitability (CEP) | News | 18 June 2019 | Strasbourg, France
The EDQM has now finalised the review and update of the vast majority of CEP dossiers for sartans containing a tetrazole ring structure. The CEP dossiers have been assessed following a risk- and science-based approach. When sufficient data was given to demonstrate that there were no risks of presence of nitrosamines and a limit in the specification of the active substance was not necessary (based...
European Pharmacopoeia / International harmonisation | News | 13 June 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of the general chapter on Pharmacopoeial harmonisation (5.8) which will be published in the upcoming 10th Edition (implementation date 1 January 2020). The concept of the chapter has changed significantly.
Patient & Consumer Protection | News | 13 June 2019 | Strasbourg, France
The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was based on the scientific assessment of angiotensin-II-receptor antagonists (sartans) containing a tetrazole group performed by the Committee for Medicinal Products for Human Use (CHMP), the conclusions of which...
Transfusion / Public awareness | News | 13 June 2019 | Strasbourg, France
EDQM supports World Blood Donor Day on 14 June 2019. We invite all our website visitors and social media followers to consider blood donation and to mobilise their families, friends and colleagues to do the same. When it comes to blood donation, every link in the chain matters!
Certification of suitability (CEP) / Procedure of certification (general) | News | 12 June 2019 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Products and Services | News | 11 June 2019 | Strasbourg, France
The EDQM announces the availability of: • 18 Replacement batches for Ph. Eur. Reference Standards: Y0001811 Sitagliptin containing impurity A Y0000853 Fluvoxamine for system suitability H1500000 Hyoscine hydrobromide Y0001250 Entacapone impurity A Y0001094 Aceclofenac for peak identification Y0000596 Diazepam for system suitability - * psy Y0000400 Naltrexone hydrochloride...
EDQM / All activities | News | 06 June 2019 | Strasbourg, France
The latest EDQM Annual Report provides an overview of its accomplishments. In 2018 much was accomplished in the field of setting quality standards for the manufacture and control of medicines in Europe and beyond.
European Pharmacopoeia / Monograph | News | 05 June 2019 | Strasbourg, France
The names and definitions of reagents used as stationary phases for gas chromatography columns have been harmonised for the 10th Edition of the Ph. Eur. At the same time, individual monographs have been reviewed to improve the correspondence between chromatography column brand names1 and the reagents described.
European network of OMCLs / General European OMCLs Network activities | News | 04 June 2019 | Strasbourg, France
The 24th annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs), jointly organised by the EDQM and the Medicines and Healthcare products Regulatory Agency (MHRA, UK), took place on 13-17 May in London.
Reference Standard / Collection & Catalogue | News | 17 May 2019 | Strasbourg, France
In order to overcome the temporary shortage of this CRS and until the replacement batch is made available, it is advised to prepare the system suitability resolution solution for the test of related proteins described in the monographs 0950 (Somatropin concentrated solution), 0951 (Somatropin) and 0952 by using the Ph. Eur. Somatropin CRS Batch 3 (Cat. No. S0947000).
Products and Services | News | 15 May 2019 | Strasbourg, France
The EDQM announces the availability of 2 New Ph. Eur. Reference Standards, 21 Replacement batches for Ph. Eur. Reference Standards and 8 Withdrawn products for Ph. Eur. Reference Substances.
European Pharmacopoeia / Monograph | News | 13 May 2019 | Strasbourg, France
The 2020 subscriptions are now available for sale on our webstore.
Certification of suitability (CEP) / Good manufacturing practice (GMP) | News | 09 May 2019 | Strasbourg, France
A review of data from API inspections conducted by the EDQM between 2006 and 2018 is now available.
Patient & Consumer Protection / Cosmetics | News | 02 May 2019 | Strasbourg, France
The quality of tooth whiteners and whitening strips was assessed in a Market Surveillance Study carried out in 12 European countries and completed in 2018 by the network of Official Cosmetics Control Laboratories (OCCLs), coordinated by the EDQM.
European Pharmacopoeia / Pharmacopoeial discussion group (PDG) | News | 23 April 2019 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on Wednesday 13 March 2019.