European Pharmacopoeia / Monograph | News | 13 December 2019 | Strasbourg, France
The Ph. Eur. Commission proposes to revise the general monograph on Substances for pharmaceutical use (2034). This proposal has been made further to the European Commission referral C(2019)2698 of 2 April 2019 and the review initiated by the European Medicines Agency (EMA) in September 2019 under Article 5(3) of Regulation (EC) No. 726/2004 to provide guidance to marketing authorisation holders...
European Pharmacopoeia / Ph. Eur. Commission | News | 11 December 2019 | Strasbourg, France
During its 165th session, held in Strasbourg on 26 and 27 November 2019, the European Pharmacopoeia (Ph. Eur.) Commission (re)appointed more than 850 experts to its current 21 groups of experts and 39 active working parties for a new term running from November 2019 to November 2022.
European Pharmacopoeia / Ph. Eur. Commission | News | 10 December 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is undertaking a review of the dosage form monographs and related general chapters. Five different texts finalised by Ph. Eur. Group of Experts 12 have been launched for public consultation in Pharmeuropa 31.4 until 31 December 2019.
Products and Services | News | 03 December 2019 | Strasbourg, France
The EDQM announces the availability of: 9 new European Pharmacopoeia (Ph. Eur.) reference standards; 20 replacement batches for Ph. Eur. reference standards.
EDQM / All activities | News | 21 November 2019 | Strasbourg, France
As part of its efforts to improve customer service, the EDQM has developed a streamlined version of its HelpDesk and FAQs platform. The new HelpDesk was redesigned on the basis of feedback received from users and now benefits from a more intuitive interface, which is expected to enhance customer support and improve user experience.
Reference Standard / General | News | 14 November 2019 | Strasbourg, France
The new secondary site of the EDQM, being opened and inaugurated on 15 November 2019, will enable the safe storage of contingency stocks of European Pharmacopoeia reference standards and ensure their distribution worldwide in the event of major incidents at its main site in Strasbourg.
European Pharmacopoeia / General text/chapter | News | 14 November 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on general chapter 2.4.20. Determination of elemental impurities. Updated in the context of discussions within the Pharmacopoeial Discussion Group (PDG), the text is intended to become the new harmonised standard for elemental impurities testing.
Transfusion / Blood Quality Management system (B-QM) | News | 08 November 2019 | Strasbourg, France
The year 2020 will mark 10 years of successful collaboration between the EU and the EDQM in the field of blood. On this occasion the EDQM, in collaboration with the European Commission, is organising a conference on the latest challenges faced by European Blood Establishments. This event will cover topics such as data protection, demographic changes among blood healthcare professionals, the...
Products and Services | News | 08 November 2019 | Strasbourg, France
Processing & Shipment of orders in December : please check our deadlines!
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.