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...
European Pharmacopoeia / Public enquiry | News | 17 January 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has launched a public consultation on how the current situation with dissolution testing in Ph. Eur. Finished Products Monographs (FPMs) could be improved.
European Pharmacopoeia / Monograph | News | 15 January 2019 | Strasbourg, France
The EDQM wishes to inform stakeholders that the monograph for Octreotide (2414) will be published in the 10th Edition of the European Pharmacopoeia and will become effective on 1 January 2020.
European Pharmacopoeia / General | News | 14 January 2019 | Strasbourg, France
Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the elaboration of monographs on radiopharmaceuticals was published by the EDQM in 2010.
European Pharmacopoeia / Ph. Eur. Commission | News | 14 January 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission has decided to replace the Histamine Sensitisation Test “HIST” (test in mice) with a standardised CHO cell clustering assay (in vitro cell-based test) for residual pertussis toxin testing in acellular pertussis vaccines, as of next year. The introduction of a standardised CHO cell-clustering assay for residual pertussis toxin testing is based on...
European Pharmacopoeia / Public enquiry | News | 09 January 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on a new general chapter, 2.6.32. Test for bacterial endotoxins using recombinant factor C (rFC). This is not a new topic for the Ph. Eur. which was one of the first pharmacopoeias to refer to rFC, namely in chapter 5.1.10 Guidelines for using the test for bacterial endotoxins in Supplement 8.8 (2016), allowing the...
Certification of suitability (CEP) / Procedure of certification (general) | News | 14 December 2018 | Strasbourg, France
Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM policy documents have been revised and are available.
Certification of suitability (CEP) / Chemical purity | News | 14 December 2018 | Strasbourg, France
The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019.
European network of OMCLs / Human Biologicals (OCABR) / Vaccines | News | 11 December 2018 | Strasbourg, France
In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s protocol section (Section 3) have been revised to delete the test.
European Pharmacopoeia / Animal testing | News | 06 December 2018 | Strasbourg, France
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents.
European Pharmacopoeia / Ph. Eur. Commission | News | 30 November 2018 | Strasbourg, France
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts and 128 revised texts. All of the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 January 2020 and will be published in 10th Edition of...
European Pharmacopoeia / General text/chapter | News | 28 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.