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European Pharmacopoeia / Monograph | News | 01 April 2019 | Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described as clearly and consistently...
European Pharmacopoeia / Monograph | News | 01 April 2019 | Strasbourg, France
It has been brought to our attention that the conversion factor of 13.63 prescribed in the assay is inappropriate and leads to an overestimation of the content. Therefore, it has to be replaced by a factor of 13.03.
Reference Standard / General | News | 28 March 2019 | Strasbourg, France
Established specifically for their intended use, pharmacopoeial reference standards are thoroughly characterised and their uses may go beyond those described in compendia, although a clear-cut distinction between quantitative use and qualitative use is essential.
European Pharmacopoeia / Ph. Eur. Commission | News | 28 March 2019 | Strasbourg, France
During its 163rd session, held in Strasbourg on 19-20 March 2019, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Torbjörn Arvidsson (Sweden) as its Chair. As the 19th Chair of the Ph. Eur. Commission since its establishment in 1964, Prof. Arvidsson will be supported by two Vice-chairs who will be elected in June.
European network of OMCLs / General European OMCLs Network activities | News | 27 March 2019 | Strasbourg, France
The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant...
European Pharmacopoeia / General text/chapter | News | 08 March 2019 | Strasbourg, France
The revised limit test for arsenic (Method A, 2.4.2) was published in Supplement 9.4 of the European Pharmacopoeia and entered into force on 1 April 2018. Upon implementation, the EDQM was made aware of a problem with the suitability test (UV-visible absorbance) of the newly introduced reagent silver diethyldithiocarbamate solution R (1110401), as many laboratories reported difficulties in...
Products and Services | News | 07 March 2019 | Strasbourg, France
The EDQM announces the availability of 3 New Ph. Eur. Reference Standards and 24 Replacement batches for Ph. Eur. Reference Standards.
Patient & Consumer Protection / Anti-falsification activities | News | 06 March 2019 | Strasbourg, France
Slovenia signed the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS 211, MEDICRIME Convention) on 6 March 2019.
European Pharmacopoeia / General text/chapter | News | 18 February 2019 | Strasbourg, France
The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8. The revised part is reproduced here after: The instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material. Sodium aminosalicylate dihydrate for equipment qualification CRS may be used when proceeding by...
European Pharmacopoeia / Ph. Eur. Commission | News | 13 February 2019 | Strasbourg, France
The EDQM is renewing its call for expressions of interest to join the European Pharmacopoeia (Ph. Eur.) as an independent scientific expert. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the private sector (pharmaceutical or chemical industries), academia, research organisations and...
Reference Standard / Chemical reference standard (CRS) | News | 12 February 2019 | Strasbourg, France
The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make traceability transparent. The mass fractions of the assigned element are traceable to the SI units (mole and kilogram) through an uninterrupted chain, similar to...
Transplantation / Legal Framework | News | 11 February 2019 | Strasbourg, France
Montenegro ratified the Council of Europe Convention against Trafficking in Human Organs on 5 February 2019. The Convention will commence having legal effect in the country as of 1 June 2019. The Convention identifies various activities constituting human organ trafficking which ratifying member states must consider as criminal offences.
Products and Services | News | 07 February 2019 | Strasbourg, France
29 new Ph. Eur. Reference Substances (RS) and 18 replacement batches released in January 2019
Transfusion / General | News | 05 February 2019 | Strasbourg, France
The EDQM and the European Commission (EC) brought together stakeholders involved in the field of plasma to discuss ways forward for improving plasma supply management and donor protection, during a symposium organised in Strasbourg on 29 and 30 January 2019.
Certification of suitability (CEP) / CEP suspension | News | 04 February 2019 | Strasbourg, France
Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended CEP R1-CEP 2009-247-Rev 02/losartan potassium, form I, held by HETERO LABS, Limited, due to the detection of low levels of N-nitroso-N-methylamino butyric acid (NMBA) and N-nitroso-...