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Call for experts – Aluminium in parenteral nutrition solutions
Although certain European countries already regulate aluminium in parenteral nutrition solutions (PNS), there are currently no European standards limiting the maximum amount of aluminium in these solutions, which are often prepared extemporaneously. To address this situation, the European...
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.1
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 35.1. The table below lists the substances...
Ph. Eur. Commission welcomes Ethiopian FDA as observer
The European Pharmacopoeia (Ph. Eur.) Commission granted observer status to the Ethiopian Food and Drug Administration (EFDA) during its 174th session (November 2022). This decision demonstrates the dynamism of the European Pharmacopoeia, which now has 31 observers from around the world, in...
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines
At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine...
Management of EDQM CEP documents: EDQM introduces a consultation phase
The EDQM has updated its policy for the elaboration of documents related to the Certification of Suitability (CEP) procedure. Detailed information on the types of documents and the different steps in the elaboration process can be found here. The elaboration process for CEP documents is placed...
1 new Ph. Eur. reference standards and 13 replacement batches released in December 2022
The EDQM announces the release of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 13 replacement batches.
European Paediatric Formulary: Chloral Hydrate Oral Solution monograph open for public consultation in Pharmeuropa PaedForm
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 5 of Pharmeuropa PaedForm, in which the draft text for Chloral hydrate 100 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. The...
Deadline extended to 13 January 2023 - Contribute to shaping the future EDQM strategy – Stakeholder survey
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a survey to seek the input of its stakeholders, including the (wider) public. Your input will help shape our upcoming four-year strategy (2024-2027) and contribute to ensuring the EDQM continuously meets your...
Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders (3.2.9) in European Pharmacopoeia Supplement 11.1, with an...
Certification monthly report of activities: End of November 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2022 Certification Monthly Report For more information, access the Certification Database.
5 new Ph. Eur. reference standards and 12 replacement batches released in November 2022
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of 5 new European Pharmacopoeia (Ph. Eur.) reference standards.
“Polypharmacy and ageing” – EDQM participation in ESCP symposium in Prague
Representatives of the European Directorate for the Quality of Medicines & HealthCare (EDQM) participated in the 50th European Society of Clinical Pharmacy (ESCP) Symposium, entitled “Polypharmacy and ageing – individualized, person-centered care”, held in Prague from 19 to 21 October 2022....
Full OCABR guideline for Pandemic COVID-19 vaccine, Inactivated, now available
The guideline for Pandemic COVID-19 vaccine, Inactivated, in force since 4 May 2022, contains the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR). It has now been updated to include a model protocol for the...
European Paediatric Formulary: Revised Phosphate Oral Solution monograph published
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the revised monograph Phosphate 60 mg/mL Oral Solution in the European Paediatric Formulary (PaedForm). This revised monograph (the first PaedForm text to undergo revision) was published in Issue 4 of...
Certification monthly report of activities: End of October 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October Certification Monthly Report For more information, access the Certification Database.
7 new Ph. Eur. reference standards and 14 replacement batches released in October 2022
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS...
“CEP of the future”: second project update
Since conducting a wide public survey on the Certification of suitability to the European Pharmacopoeia monographs (CEP), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been working on the design of the CEP of the future. Different aspects were presented to...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.4
Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.4. The table below lists the substances...
EDQM changes CEP policy regarding chemical applications for polymorphs
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently modified its policy on chemical applications for polymorphs. A request for a Certificate of suitability to the European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now...
Ph. Eur. publishes Cannabis flos draft monograph in Pharmeuropa for comment
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new draft monograph on Cannabis flos (3028). The draft text covers the herbal drug defined as dried, whole or fragmented, fully developed shoot apices of female cultivars of Cannabis sativa L. It is to be read in conjunction with...
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