Newsroom
Celebrating 60 years of excellence – Explore our conference programme
Celebrating 60 years of excellence and dedication to ensuring the availability of and access to good quality and safe medicines and health products, the EDQM is gearing up for a major event. Join us for a high-level gathering that pays tribute to our rich history while sparking discussions on...
Publication of BSP study outcome on measuring procoagulant activity in human normal immunoglobulin available online
The outcome of a successful study on the determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay has recently been published in the EDQM online journal Pharmeuropa Bio & Scientific Notes. The article details the methods...
1 May 2024
Public holiday: EDQM offices closed on 1 May 2024
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Wednesday 1 May 2024.
Normal business hours will resume on Thursday 2 May 2024.
Shortage of aprepitant, powder for oral suspension – Expert opinion of the EDSForm Working Party
Aprepitant is a NK1 receptor antagonist that is mainly used in the prevention of chemotherapy-induced or postoperative nausea and vomiting. The only licensed medicinal product containing aprepitant that is appropriate for paediatric patients – a powder for oral suspension (Emend 125 mg powder for...
Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages
The task of the European Drug Shortages Formulary Working Party (EDSForm WP), created at the end of November 2023, is to define both short-term and long-term actions aimed at mitigating the negative impact of medicine shortages on public health. Short-term actions involve compiling technical...
Public consultation on Traceability of Medicines in Hospital Settings
The European Directorate for the Quality of Medicines & HealthCare is seeking comments from interested parties on a draft guidance document on the topic of “Traceability of Medicines in Hospital Settings”. The objective of this project is to provide regulatory authorities and stakeholders with a...
Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689)
Further to the premature depletion of stocks of the Immunoglobulin (anti-A, anti-B antibodies test Negative control) BRP (cat. # Y0001689), we wish to inform users that the distribution quota has been revised. This BRP will be distributed to plasma-derived therapeutic product manufacturers and...
Deadline extended to 30 April: survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
Scientific Assistant – Scientific Procurement
Do you wish to further develop your scientific skills in the procurement of chemical and biological substances?
European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.). Both chapters...
New general chapter on Phage therapy medicinal products (5.31) adopted and pre-published on the EDQM website
Rising levels of antimicrobial resistance in recent years, identified as one of the leading threats to global public health and development, have prompted renewed interest in the use of phage therapy for the treatment of bacterial infections. This led the European Pharmacopoeia Commission (EPC)...
JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs
The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the...
How to identify the manufacturing sites linked to CEP application (revised document)?
Please consult the revised policy document which has been updated to complete the identification of the manufacturing sites by the SPOR OMS coordinates. The use of these coordinates is mandatory, and companies should ensure that their organisation name and location address(es) given to the EDQM...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.2
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 36.2. The table below lists the substances...
Certification monthly report of activities: End of March 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2024 Certification Monthly Report For more information, access the Certification Database.
As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
The revised version of the EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now available and will be implemented as of 1st May 2024. This guideline and other key documents (QOS, top ten deficiencies), as well as the...
Pharmeuropa 36.2 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 36.2 is 30 June 2024. Users and interested parties are welcome to comment on these drafts. It should be...
Survey on strategy for Ph. Eur. quality standards for monoclonal antibodies
In 2014, the European Pharmacopoeia Commission (EPC) launched a pilot phase on setting public standards for therapeutic monoclonal antibodies (mAbs) (“MAB pilot phase”). This pilot phase was intended to explore the feasibility of establishing individual monographs for multi-source mAbs, as well...
7 new Ph. Eur. reference standard and 17 replacement batches released in March 2024
New Ph. Eur. reference standards and 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...
Cannabidiol impurity J CRS now available
The standard cannabidiol impurity J CRS that is described in the monograph on Cannabidiol (3151) is now available for users under catalogue code Y0002436. More information on how to order is available on the EDQM website.
Revised Regulation for the Ozone-Depleting Substances
Regulation (EU) 2024/590 on substances that deplete the ozone layer entered into force on 11 March 2024. The rules governing the placing on the market and use of ozone-depleting substances (ODSs) for essential laboratory and analytical uses have now changed. Under the new regulation, standards...
How CEP holders can avoid the rejection of notifications
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
Stakeholder consultation – New draft technical guide on FCM compliance
Stakeholder consultation – New draft technical guide on FCM compliance A new draft technical guide on documentation supporting compliance and safety of food contact materials and articles is now open for comment. The European Directorate for the Quality of Medicines & HealthCare (EDQM) invites...
The template of Quality Overall Summary (QOS) to be submitted for Certification applications has been adapted to the current needs!
A new version of the QOS template is now available. It may be used from January 2024 and will become mandatory as of April 2024. The QOS (eCTD Module 2) has to be provided along with an initial submission since it is essential in the review of a new CEP application. This updated template gives...
Certification monthly report of activities: End of February 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2024 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standard and 15 replacement batches released in February 2024
New Ph. Eur. reference standards and 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...
Two new monographs published in European Paediatric Formulary
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added two new monographs Clonidine hydrochloride 10 µg/mL oral solution and Furosemide 2 mg/mL oral solution, to the European Paediatric Formulary after a successful public consultation phase. The Formulary now...
Stakeholder consultation – Draft documents to support safe and correct use of herbal food supplements
From 23 February 2024 to 5 April 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft guidance document for healthcare professionals and a draft leaflet for patients/consumers...
Save the date: webinar on CEP 2.0
The EDQM invites CEP holders and users to participate in a public webinar on the 9th April 2024 to share their experiences on the use of CEP 2.0. More info at: https://www.edqm.eu/en/cep-2-0-fresh-feedback-from-stakeholders
Certification monthly report of activities: End of January 2024
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2024 Certification Monthly Report For more information, access the Certification Database.
Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!
This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. The content of this document is intended to help applicants to build their application in conjunction with the EDQM...
EDQM’s ISO 9001:2015 certification maintained
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 28 and 29 November 2023 by the official French standardisation body Association française de...
1 new Ph. Eur. reference standard and 29 replacement batches released in January 2024
New Ph. Eur. reference standards and 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...
BSP study outcome published in Pharmeuropa Bio & Scientific Notes – Human tetanus immunoglobulin BRP batch 2
The outcome of the Biological Standardisation Programme study BSP140 to establish the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin batch 2 has been published in the online journal Pharmeuropa Bio & Scientific Notes of the European...
Ph. Eur. progress in the field of homoeopathic manufacturing methods
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on European Pharmacopoeia (Ph. Eur.) texts on homoeopathic manufacturing methods, with the recent publication (January 2024) of three revised general monographs in...
CEP holders invited to comment on draft monographs published in Pharmeuropa 36.1
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 36.1. The table below lists the substances...
New strategy for N-nitrosamine impurities in Ph. Eur. monographs
At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Regarding active substances The EPC agreed to delete the Production section covering N-nitrosamine impurities from existing individual...
EDQM clarifies its policy for confidentiality and declassification of CEP documents
EDQM has elaborated a document describing the principles for the declassification of documents pertaining to the CEP procedure while ensuring when necessary, the confidentiality of information.
Certification monthly report of activities: End of December 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December 2023 Certification Monthly Report For more information, access the Certification Database.
8 replacement batches released in December 2023
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 Chemical Reference Substances (ICRS)...
Pharmeuropa 36.1 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 36.1 is 31 March 2024. Users and interested parties are welcome to comment on these drafts. It should be...
Cannabis flower for system suitability HRS and cannabidiol for cannabis CRS now available
The standards cannabis flower for system suitability HRS and cannabidiol for cannabis CRS that are described in the newly adopted monograph on Cannabis flower (3028) are now available for users under catalogue code Y0002440 and Y0002422 respectively. More information on how to order is available...
EDQM welcomes EU Parliament and Council’s political agreement on enhanced safety and quality for substances of human origin
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe welcomes the recent provisional agreement reached between the European Parliament and the Council of the European Union (EU) on the draft regulation on blood, tissues and cells. This marks a pivotal...
Implementation of the European Pharmacopoeia Supplement 11.5 – Notification for CEP holders
Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2024, and to follow the...
New general chapter on comparability of alternative analytical procedures published in European Pharmacopoeia
A new general chapter, Comparability of alternative analytical procedures (5.27), has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the European Pharmacopoeia Commission at its 176th session in June 2023. This new general chapter describes how...
BSP study outcome published online – Heparin Low-Molecular-Mass CRS batches 4 & 5
The outcome of the BSP121 study to establish batches 4 and 5 of the European Pharmacopoeia Heparin Low-Molecular-Mass for Calibration Chemical Reference Substance (CRS) has been published in the online journal Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed® (Pharmeur Bio...
General chapters on powder characterisation techniques modernised
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is proud to highlight the remarkable progress made in 2023 on five general chapters of the European Pharmacopoeia (Ph. Eur.) that cover procedures for powder characterisation. The three revised and two newly elaborated...
European Pharmacopoeia Supplement 11.5 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.5 is now available and will be applicable in 39 European countries as of 1 July 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...
Implementation of pharmaceutical care in daily practice in South-eastern Europe Health Network (SEEHN) member states
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the results of a survey conducted in 2022 among states who are members of both the South-eastern Europe Health Network (SEEHN) and the Council of Europe. The main objective of this initiative was to...
The CEP 2.0 guideline on requirements for the content of the dossier has been updated
The guideline on requirements for the content of the CEP dossier according to the CEP 2.0 has been revised to include updated requirements and clarifications related to sections 3.2.S.4.1 & 3.2.S.4.2. and an updated Annex 1.
European Pharmacopoeia welcomes Egyptian Drug Authority as observer
The Egyptian Drug Authority has been granted observer status to the European Pharmacopoeia Commission (EPC). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 33 observers from around the world in addition to 39 European countries and the European...
Information for CEP applicants - EDQM-DCEP non-working days in 2024
In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...
EDQM publishes market surveillance study on formaldehyde in cosmetic products
A market surveillance study conducted by the European Network of Official Cosmetics Control Laboratories (OCCLs) has found formaldehyde in approximately 30% of the products tested. Formaldehyde is a skin sensitiser and presumed carcinogen. Its use in cosmetic products is prohibited by European...
Outcome of the 177th session of the European Pharmacopoeia Commission, November 2023
The European Pharmacopoeia Commission (EPC) held its 177th session on 21 and 22 November 2023. The EPC adopted 77 texts at this session, to be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.6 (July 2024) and be effective as of 1 January 2025. These 77 texts included nine new...
Certification monthly report of activities: End of November 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of November 2023 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. pre-publishes revised Propylene glycol monograph
The revised monograph on Propylene glycol (0430) was adopted by the European Pharmacopoeia Commission (EPC) at its 177th session held on 21 and 22 November 2023. The monograph was revised in response to the public health risk posed by the discovery of ethylene glycol (EG) and diethylene glycol...
OMCL confirms falsification of Ozempic® batches
Following concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) and a member of the European OMCL Network, has determined by analytical testing that suspected...
European Paediatric Formulary: Flecainide acetate oral solution and Valaciclovir oral solution monographs in public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 8 of Pharmeuropa PaedForm. The experts of the PaedF working party are glad to publish the ninth and tenth monographs for public consultation, Flecainide acetate 10 mg/mL oral solution and...
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...
Certification monthly report of activities: End of September 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September 2023 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.4
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 35.4. The table below lists the substances...
Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission as a member, facilitating reach and enhancing impact of pharmacopoeial standards harmonisation
The Pharmacopoeial Discussion Group (PDG) today announced the Indian Pharmacopoeia Commission (IPC) as a PDG member.
Implementation of the European Pharmacopoeia Supplement 11.4 – Notification for CEP holders
Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2024, and to follow the...
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.
Find information on the EDQM's responses to N-nitrosamine contamination and the COVID-19 pandemic.