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-...
European Pharmacopoeia / Monograph | News | 31 January 2019 | Strasbourg, France
At its 162nd session, the European Pharmacopoeia (Ph. Eur.) Commission approved a new edition of the Guide for the elaboration and use of monographs on vaccines and immunosera for human use. The Guide provides guidance to experts on the information to be included in Ph. Eur. monographs related to vaccines and sera for human use, and to harmonise the style of the different monographs.
European Pharmacopoeia / Monograph | News | 25 January 2019 | Strasbourg, France
A revised version of the monograph on Oxytetracycline hydrochloride (0198) has been adopted by the European Pharmacopoeia Commission and will be published in the upcoming 10th Edition. This revised version will include impurity F as a specified impurity and will introduce a limit of maximum 1.0% for the sum of impurities D, E and F, changes seen as a temporary solution that would alleviate the...
Products and Services | News | 24 January 2019 | Strasbourg, France
The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.
Certification of suitability (CEP) / Procedure of certification (general) | News | 23 January 2019 | Strasbourg, France
Supplement 9.8 of the Ph. Eur is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of July 2019, and to follow the instructions given in the document.
Certification of suitability (CEP) / CEP suspension | News | 18 January 2019 | Strasbourg, France
Following new information received recently by EDQM about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions will have been implemented by the relevant company: due to the detection of low levels of N-nitrosodiethylamine (NDEA), suspension of the CEP R1-CEP 2010...