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European Pharmacopoeia / International harmonisation | News | 21 February 2020 | Strasbourg, France
At the 11th International Meeting of the World Pharmacopoeias (IMWP) co-hosted by the WHO and the EDQM in Strasbourg (France), national and regional pharmacopoeias brought forward initiatives to strengthen their co-operation as a way to improve public health outcomes for patients.
European Pharmacopoeia / Ph. Eur. Commission | News | 20 February 2020 | Strasbourg, France
At its 165th session in November 2019, the European Pharmacopoeia Commission adopted two general chapters related to testing for particulate contamination in pharmaceutical preparations.
European Pharmacopoeia / General text/chapter | News | 12 February 2020 | Strasbourg, France
At its 165th session in November 2019, the European Pharmacopoeia Commission adopted a new version of one of its widely used general methods, chapter 2.2.2. Degree of coloration of liquids, which has been extensively revised to include the instrumental method. The revised chapter will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, available in July 2020 (implementation date: 1...
European Pharmacopoeia / General | News | 10 February 2020 | Strasbourg, France
On 9 February 2020, the Convention on the Elaboration of a European Pharmacopoeia will enter into force in Albania, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country.
European Pharmacopoeia / Nitrosamines | News | 28 January 2020 | Strasbourg, France
A new web page providing centralised access to all information related to nitrosamine contamination is now available on the EDQM website. It presents a general overview of the issue and provides details of the actions taken in the different sectors of activity concerned: the European Pharmacopoeia, the Certification of Suitability to the monographs of the European Pharmacopoeia, and the network...
European Pharmacopoeia / General text/chapter | News | 24 January 2020 | Strasbourg, France
The new Pharmeuropa website is now online with a series of new features available to improve the user experience. As part of its efforts to enhance customer service and taking user feedback into account, the EDQM has redesigned the platform to include the following features: - single sign-on with other EDQM websites using the same authentication database, including Ph. Eur. online and PaedForm...
European Pharmacopoeia / Monograph | News | 21 January 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) 9th Edition has been obsolete since 1 January 2020. Consequently, the 9th Edition online and all previous versions, including the Ph. Eur. archives for 9th Edition clients, will no longer be accessible starting 1 March 2020. The Ph. Eur. 10th Edition and its supplements are available to subscribers on the dedicated European Pharmacopoeia online platform....
European Pharmacopoeia / Monograph | News | 16 January 2020 | Strasbourg, France
With a view to improving the correspondence between liquid chromatography column brand names (provided in the Knowledge Database) and the reagents used to describe the stationary phases for these columns, an overall review of all the monographs concerned has been launched. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described...
European Pharmacopoeia / Monograph | News | 16 January 2020 | Strasbourg, France
The European Pharmacopoeia Commission adopted a new monograph, on Rosuvastatin tablets (3008), at its 163rd session in March 2019. The monograph was published in Supplement 10.1 of the European Pharmacopoeia (Ph. Eur.), available since October 2019, and will become effective on 1 April 2020.
European Pharmacopoeia / Public enquiry | News | 07 January 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.1 is 31 March 2020. Users and interested parties are welcome to comment on these drafts. It should be noted that: • although draft monographs must not be regarded as official standards, they will, once adopted by the European...
Products and Services | News | 07 January 2020 | Strasbourg, France
The 10.2 supplement of the European Pharmacopoeia is now available and will be applicable in 38 European countries as of 1 July 2020.
European Pharmacopoeia / International harmonisation | News | 20 December 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) general chapter on Pharmacopoeial harmonisation (5.8) provides users with general guidance on the work of the EDQM in this field and details of the information included in harmonised Ph. Eur. general chapters and monographs. This information enables users to understand and correctly apply Ph. Eur. texts (monographs on excipients and general chapters)...
European Pharmacopoeia / General text/chapter | News | 19 December 2019 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 2.8.26 on contaminant pyrrolizidine alkaloids. Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31 March 2020.
Paediatric Formulary | News | 18 December 2019 | Strasbourg, France
The EDQM is pleased to announce that the European Paediatric Formulary is now available free of charge on a dedicated online platform. This is a major achievement for the PaedForm Working Party and all the stakeholders involved, since it not only embodies several years’ work and dedication to the project, but feeds into the fundamental human right of equal access to quality healthcare.
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...