Newsroom
Reminder: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for any CEP applications
Since 1 June 2023, applicants must provide in the application forms for any type of submission (new dossiers, sister files, revisions and renewals) the EMA SPOR/OMS ORG_ID and LOC_ID (unique identifiers for an organisation and its locations) for all companies involved in Certification of...
1 new Ph. Eur. reference standard and 14 replacement batches released in November 2023
New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Distribution quota 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...
2024 EDQM virtual training programme: Ph. Eur. texts related to biologicals and microbiology chapters
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has opened registration for its 2024 virtual training programme, composed of four independent modules on European Pharmacopoeia (Ph. Eur.) texts related to biologicals and on microbiology chapters. Get full information on...
Falsification of medical devices – Results of European survey
The falsification of medical devices is a serious international matter of concern, but little data is available, making it difficult to assess the current state of affairs. To help bridge this gap, the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical...
Sourcing of suppliers of personal protective equipment
In the context of an upcoming call for tenders, the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) would like to meet prospective suppliers who offer “Supply and maintenance of personal protective equipment (PPE), in particular lab...
Swedish Medical Products Agency hosts 12th OCCL meeting in Uppsala
The Swedish Medical Products Agency (MPA) hosted the 12th meeting of the European Network of Official Cosmetics Control Laboratories (OCCLs) on 17 and 18 October 2023. The meeting brought together 43 participants from national authorities in 24 countries, attending both on site and online....
Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
Due to premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that a tight distribution quota has been established. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...
EDQM launches updated version of the EuroGTP II tool to ensure good tissue and cell practices for human application
To help ensure quality and safety in the field of substances of human origin (SoHO), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been entrusted with managing the EuroGTP II tool for good tissue and cell practices. Starting on 15 November 2023, this interactive...
Certification monthly report of activities: End of October 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of October 2023 Certification Monthly Report For more information, access the Certification Database.
EDQM end-of-year closure: order and shipment deadlines
Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from Thursday 21 December 2023 (12 noon CET) to Tuesday 2 January 2024 (8 a.m. CET)....
CEP 2.0: new requirements for the content of the chemical purity and herbal drugs/herbal drug preparation dossiers
The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further clarification regarding the presentation and content of the “Specification” section (3.2.S.4.1) to all applicants preparing an application in CEP 2.0 format. When completing section 3.2.S.4.1,...
Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored a report with a broad range of academics and interested parties, entitled “Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals”....
Journal of Pharmaceutical Sciences publishes results of the OMCL fingerprint study on tadalafil API samples
The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on tadalafil, the results of which have been published in the Journal of Pharmaceutical Sciences, Vol. 112 (2023). An API fingerprint is a specific...
3 new Ph. Eur. reference standards and 21 replacement batches released in October 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...
Pharmacopoeial Discussion Group Achievements
The Pharmacopoeial Discussion Group (PDG) held its annual autumn meeting from 3 to 4 October 2023. The group welcomed the Indian Pharmacopoeia Commission (IPC) as a new member during the meeting (link). The addition of the IPC, a first in the over 34-year history of the PDG, facilitates the reach...
OMCL Gene Therapy Working Group study published
The outcome of a study run in the framework of the European Network of Official Medicines Control Laboratories (OMCLs) Gene Therapy Working Group (GTWG) has been published online in Pharmeuropa Bio & Scientific Notes. The article, entitled “Validation of a qPCR method for determination of viral...
Corneal transplants – EDQM publishes new information booklet
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published an information booklet on corneal transplants. It explains what a corneal transplant is, who may be concerned and provides expert information on the different implantation procedures and techniques, along...
EDQM joins efforts to tackle medicine shortages
Medicine shortages are a growing problem that compromises patient care. Two key committees at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC), are...
Revised general chapter 2.7.24 Flow cytometry in Pharmeuropa 35.4
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter Flow cytometry (2.7.24), published in this quarter’s issue of Pharmeuropa (35.4) for comment (public deadline 31 December 2023). The revision of this general chapter is of high importance since it...
Newsletter Transplant 2023 – Informing the future of transplantation
A new edition of Newsletter Transplant has just been published, presenting data on donation and transplantation activities worldwide in 2022. This year’s report covers a record 86 countries. It is produced annually thanks to the invaluable support of the Spanish Organización Nacional de...
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