Certification of suitability (CEP) / Procedure of certification (general) | News | 15 July 2019 | Strasbourg, France
According to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format.
European Pharmacopoeia / Public enquiry | News | 15 July 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the mandatory dosage form monographs. As part of this process, its Group of experts 12 has revised or elaborated several texts involving preparations which are applied to the skin and one involving intravesical preparations. These proposed revisions have been published in Pharmeuropa 31.3 and concern the following texts...
European Pharmacopoeia / Public enquiry | News | 12 July 2019 | Strasbourg, France
All new texts and texts having undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts. It should be noted that: • Although draft monographs must not be regarded as official standards, they will, once adopted by the European Pharmacopoeia Commission at a later date, become applicable and legally...
EDQM / All activities | News | 09 July 2019 | Strasbourg, France
The international conference “EDQM & European Pharmacopoeia: State-of-the-Art Science for Tomorrow’s Medicines” took place on 19 to 20 June 2019 in Strasbourg to mark the publication of the 10th Edition of the European Pharmacopoeia (Ph. Eur.) and the 25th Anniversary of the European OMCL Network and of the Certification of Suitability Procedure.
European Pharmacopoeia / Ph. Eur. Commission | News | 08 July 2019 | Strasbourg, France
Following the election of its new Chair, Prof. Torbjörn Arvidsson, at its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Salvador Cañigueral as its first Vice-chair for a term of three years (2019-2022). Mr Goran Benkovic was elected as second Vice-chair.
European Pharmacopoeia / Monograph | News | 08 July 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has adopted a new monograph on Rosuvastatin tablets (3008) at its 163rd session (March 2019). The monograph will be published in the 1st supplement to the 10th Edition (available in October 2019) and will become effective on 1 April 2020.
European Pharmacopoeia / Public enquiry | News | 04 July 2019 | Strasbourg, France
Multivariate statistical process control (MSPC) can be defined as the application of multivariate statistical techniques to increase the quality and the productivity of a process. It provides tools to deal with complex data and potentially correlated variables. MSPC in combination with automation may facilitate continuous manufacturing (CM) as well as real-time release testing (RTRT). It can be...
Products and Services | News | 04 July 2019 | Strasbourg, France
The EDQM announces the availability of: • 15 New Ph. Eur. reference standards; • 22 Replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) / Procedure of certification (general) | 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.
European Pharmacopoeia / Monograph | 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!
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.