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European Donation Day 2023 – Your present is their future
Organ transplantation and the human application of tissues and cells save more and more lives every year and help thousands of patients recover vital functions and lead better lives. But the number of people in need of transplantable organs, tissues and cells continues to grow at an even greater...
Ph. Eur. pre-publishes Cannabis flower monograph on the EDQM website
The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible, the Ph. Eur. decided to make...
European Paediatric Formulary: Chloral hydrate oral solution monograph published
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its fifth new monograph, Chloral hydrate 100 mg/mL oral solution, in the European Paediatric Formulary. The monograph was published for public consultation in Issue 5 of Pharmeuropa PaedForm in January 2023,...
Pharmeuropa 35.4 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 35.4 is 31 December 2023. Users and interested parties are welcome to comment on these drafts. It should...
European Pharmacopoeia Supplement 11.4 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.4 is now available and will be applicable in 39 European countries as of 1 April 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
17 replacement batches released in September 2023
Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference Substances (ICRS) and International...
CEP 2.0 – Certificates of suitability: electronic signature features
On 1 September 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) implemented electronic signatures for CEPs and some other documents as part of the CEP 2.0 project. A document explaining the features of electronic signatures is now available on our website:...
Changes to the acceptability of CEP applications for sterile grade materials
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is updating its policy concerning the acceptability of CEP applications for sterile active substances. Until now, acceptability requirements have applied to the manufacturing processes only when the manufacturer of the...
Optimising pharmacotherapy and improving patient outcomes: EDQM collaborates on article published in Frontiers in Pharmacology
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored an article with a broad range of academics and interested parties, entitled “Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and...
Safe cosmetics for young children – Second edition provides state-of-the-art guidance on cosmetic products for infants and young children
Soda or shampoo? Candy or soap? Young children can easily mistake certain cosmetics or even their packaging for foodstuff based on their perfume, appearance, form, colour or size. Ingesting the chemicals contained in such products is dangerous and small parts can easily be swallowed and may cause...
Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs
Revised versions of the widely used monographs, Water for injections (0169) and Purified water (0008), will be published in Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.). Adopted by the Ph. Eur. Commission at its 175th session in March this year, these two fundamental texts now allow...
Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an...
2 new Ph. Eur. reference standards and 16 replacement batches released in August 2023
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of amount per unit Information on change of price Change of EDQM storage/shipping conditions Information on International Chemical Reference...
CEP 2.0: Changes from September 2023 to information published in Certification Online and Knowledge databases
The launch of CEP 2.0 will bring changes, beginning in September, to the information on CEPs published on the Certification Online and Knowledge databases. The tabulated data will now include additional columns showing SPOR ORG and LOC-ID information for the holder where this is available,* as...
Certification monthly report of activities: End of August 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August 2023 Certification Monthly Report For more information, access the Certification Database.
Elemental impurity chemical reference standards (CRS) available in the EDQM reference standards catalogue
Lead solution CRS, Cadmium solution CRS, Mercury solution CRS, Arsenic solution CRS, Nickel solution CRS, Palladium solution CRS and, most recently, Platinum solution CRS are now available in the EDQM RS portfolio. For medicinal products, elemental impurities must be evaluated during risk...
Certification monthly report of activities: End of July 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of July Certification Monthly Report For more information, access the Certification Database.
2 new Ph. Eur. reference standards and 18 replacement batches released in July 2023
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Information on change of sales units Information on change of amount per unit...
N-nitrosamine impurities in Ph. Eur. monographs: update on approach
Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...
Important update on N-nitrosamine impurities in substances covered by CEPs
On 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. This update includes new...
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