Past News

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.

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...

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.

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...

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...

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...