European Pharmacopoeia / International harmonisation | News | 07 November 2019 | Strasbourg, France
The EDQM will be holding the Meet the World Pharmacopoeias Symposium in February 2020 in Strasbourg, France, right after the 11th International Meeting of World Pharmacopoeias (IMWP). The aim of this event is to update stakeholders on the achievements and current work programme of the IMWP, giving participants an opportunity to exchange views on pharmacopoeial co-operation and harmonisation.
EDQM / All activities | News | 04 November 2019 | Strasbourg, France
A phishing campaign has been launched from the internet by impersonating an EDQM user in e-mails aimed at infecting the recipients’ computers. These e-mails have been sent from outside the EDQM’s infrastructure, which is why the EDQM has no control over them.
Products and Services | News | 04 November 2019 | Strasbourg, France
The EDQM announces: - New Ph. Eur. reference standards - Replacement batches for Ph. Eur. reference standards - Removal - Future removal - Change of sales unit - Change of EDQM storage/shipping conditions - Current non availability
Certification of suitability (CEP) / Procedure of certification (general) | News | 29 October 2019 | Strasbourg, France
EMA and CMDh have published documents on their websites, (EMA/189634/2019 and CMDh/404/2019: “Information on nitrosamines for marketing authorisation holders”), which request marketing authorisation holders (MAH) to follow an investigation process described for synthesised APIs (other than sartans with a tetrazole ring). Although EDQM does not expect this issue to impact many substances, it is...
European Pharmacopoeia / International harmonisation | News | 25 October 2019 | Strasbourg, France
The latest face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan on 1-2 October 2019. WHO participated as observer. The PDG 30th Anniversary Symposium was also held on 3 October 2019.
European Pharmacopoeia / Monograph | News | 23 October 2019 | Strasbourg, France
The European Pharmacopoeia Commission adopted 43 texts related to its new approach to extraneous agents testing of immunological veterinary medicinal products (IVMPs). From starting material to final product, users will now have to follow an overall risk-management approach to ensure they apply the best testing strategies in the context of a consistent manufacturing process.
European Pharmacopoeia / Public enquiry | News | 11 October 2019 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. Users and interested parties are welcome to comment on these drafts.
Products and Services | News | 11 October 2019 | Strasbourg, France
Supplement 10.1 of the European Pharmacopoeia is now available; it will be applicable in 38 European countries as of 1 April 2020.
Transplantation / Publications / Transplant Newsletter | News | 10 October 2019 | Strasbourg, France
The EDQM/Council of Europe publishes Newsletter Transplant, which gives data on organ, tissue and cell donation and transplantation at the European and international levels.
European Pharmacopoeia / International harmonisation | News | 08 October 2019 | Strasbourg, France
On the occasion of the 30th Anniversary of the Pharmacopoeial Discussion Group (PDG), Susanne Keitel, Director of the EDQM, highlighted the progress achieved by the Group towards pharmacopoeial harmonisation and its key role in reducing the need for redundant testing by manufacturers, hence increasing the availability of medicines. Representatives of the three PDG members (the European...
Products and Services | News | 03 October 2019 | Strasbourg, France
The EDQM announces the availability of 15 New Ph. Eur. reference standards and 16 Replacement batches for Ph. Eur. reference standards.
Certification of suitability (CEP) | Notes | 30 September 2019 | Strasbourg, France
The EDQM is currently having some difficulty in achieving the assessment times for revisions and renewals of CEP applications - both initial requests and assessment of responses to requests for information. The delay is currently around 5 weeks (i.e. the outcome of the assessment is being communicated 5 weeks after the expected date). EDQM does assure applicants that the outcome will be...
Transplantation / Publications | News | 20 September 2019 | Strasbourg, France
The EDQM has just released the new edition of its Guide to the quality and safety of tissues and cells for human application. This 4th edition provides healthcare professionals with an extensive overview of the most recent advances in the field, as well as technical guidance to ensure the quality and safety of human tissues and cells for human application.
Certification of suitability (CEP) | News | 16 September 2019 | Strasbourg, France
The EDQM is aware of a quality defect in ranitidine medicines used to treat heartburn and stomach ulcers.
European Pharmacopoeia / General | News | 05 September 2019 | Strasbourg, France
The Council of Europe has played a pioneering role in a number of fields, some better known to the public than others. One such area is medicines and healthcare, with the creation of the European Pharmacopoeia 55 years ago.