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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...
Chemistry for public health: Join our EDQM team as Scientific Programme Manager
Are you ready to play a role in public health protection and contribute to the quality of medicines worldwide? Do you think you have the right blend of chemistry knowledge and experience, analytical, problem solving, project management and communication skills alongside a continuous improvement...
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”....
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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...
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...
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...
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...
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...
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.
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.
EDQM at CPhI Worldwide 2023 – Book a one-to-one CEP consultation today
The European Directorate for the Quality of Medicines & HealthCare (EDQM) will again be present at CPhI Worldwide – one of the international pharmaceutical industry’s biggest trade fairs – to be held in October this year. This event gives us an ideal occasion to connect with our clients and users...
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...
CEP 2.0: The CEP letter of access is ready for use!
The replacement of the declaration of access box on the CEP document by a separate letter of access is one of the changes introduced with the implementation of the CEP 2.0. The template for this letter is now finalised taking into account comments received during the public consultation. The CEP...
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...
CEP 2.0: implementation date
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that the CEP 2.0 will be implemented on 1 September 2023. From that date onwards, new dossier applications and renewal applications will receive a CEP 2.0, whereas revision applications will receive a...
Implementation of the European Pharmacopoeia Supplement 11.3 – Notification for CEP holders
Supplement 11.3 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 January 2024, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.3
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 35.3. The table below lists the substances...
EDQM Director elected Chair of IPRP Management Committee
The International Pharmaceutical Regulators Programme (IPRP) held its 11th Management Committee (MC) meeting in Vancouver (Canada) on 13 and 14 June 2023. The European Directorate for the Quality of Medicines & HealthCare (EDQM), an observer to the IPRP, participated in this meeting. The IPRP...
Certification monthly report of activities: End of June 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June 2023 Certification Monthly Report For more information, access the Certification Database.
Outcome of the 176th session of the European Pharmacopoeia Commission, June 2023
The European Pharmacopoeia Commission (EPC) held its 176th session on 20 and 21 June 2023. The 67 texts adopted at this session by the EPC will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 (January 2024), with an implementation date of 1 July 2024. These 67 texts included 11...
2022 Highlights – EDQM annual report now available
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...
Pharmeuropa 35.3 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 35.3 is 30 September 2023.
New Pharmeuropa Bio & Scientific Notes article now online: HCV RNA for NAT BRP replacement batch
Following the successful completion of the Biological Standardisation Programme (BSP) study for the establishment of batch 2 of the Hepatitis C Virus (HCV) RNA for nucleic acid amplification techniques (NAT) Biological Reference Preparation (BRP), the outcome has been published in the online...
4 new Ph. Eur. reference standards and 10 replacement batches released in June 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...
European Pharmacopoeia Supplement 11.3 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 is now available and will be applicable in 39 European countries as of 1 January 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...
Over 100 excipient monographs now with an FRC section in the Ph. Eur.
European Pharmacopoeia (Ph. Eur.) Supplement 11.2, which comes into force in 39 European countries on 1 July 2023, contains five excipient monographs that have been revised to include a section on functionality-related characteristics (FRCs), boosting the total of Ph. Eur. monographs that include...
New Pharmeuropa Bio & Scientific Notes article now online: Assay discrepancies using human coagulation factor VIII chromogenic kits
The outcome of a study to investigate reported assay discrepancies using human coagulation factor VIII chromogenic kits has been published in the online journal Pharmeuropa Bio & Scientific Notes. The study confirmed a significant discrepancy between the commercial chromogenic kits on the market...
European Paediatric Formulary: Furosemide oral solution monograph published for public consultation in Pharmeuropa PaedForm
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released issue 7 of Pharmeuropa PaedForm, in which the draft text for Furosemide 2 mg/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary....
6th European Training Course on Quality Management for Blood Establishments
The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe, supported by the European Commission, is organising a FREE training course on Quality Management Review (QMR) and Key Performance Indicators (KPIs) for blood establishments (BEs). Quality management in...
28th GEON annual meeting: another successful OMCL event
The 28th annual meeting of the General European OMCL Network (GEON) was held in Madrid (Spain) from 5 to 9 June 2023 and brought together about 350 participants – on-site and online – from all over Europe and beyond. The four key strategic goals of the Network, which are pivotal for the future...
Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’. The draft document for public...
CEP 2.0: List of authorities and organisations which have access to assessment and/or inspection reports.
In line with previous communication on CEP 2.0 related to the Authorities database and the updated Holder’s Commitment, the EDQM has now published the list of authorities and organisations with which the EDQM has a Memorandum of Understanding and/or Confidentiality Agreement in place allowing...
EDQM publishes 2nd edition of Herbal Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users...
Certification monthly report of activities: End of May 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May 2023 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. Commission keeps pace with veterinary vaccine development efforts
The first DNA vaccine granted a marketing authorisation in the European Union (EU) dates back to 2016 and is intended to protect Atlantic salmon against salmon pancreas disease (SPD) caused by salmon alphavirus subtype 3. Veterinary vaccine manufacturers have been developing third generation...
16 replacement batches released in May 2023
Replacement batches for Ph. Eur. reference standards Information on reference standards removed from catalogue Information on reference standards with a future removal from catalogue Change of sales units / price Information on change of amount per unit Change of EDQM storage/shipping conditions...
Call for Experts - NANO Working Party (Nanomedicines)
In June 2022, the EDQM organised and hosted a symposium on “Quality requirements for nanomedicines – what role should the European Pharmacopoeia (Ph. Eur.) play?’’, during which the participants expressed a strong interest in having texts on nanomedicines available in the...
European Pharmacopoeia welcomes Kyrgyz Republic as observer state
The European Pharmacopoeia Commission has granted observer status to the Kyrgyz Republic. This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 32 observers from around the world in addition to 39 European countries and the European Union as signatory...
Current options for shipping to Ukraine
The EDQM is able to offer several options for shipments to Ukraine. Please consult the linked table: “EDQM shipping options for Ukraine”.
PDG makes significant progress in its harmonisation efforts
The Pharmacopoeial Discussion Group (PDG)¹ works to harmonise the technical content of selected excipient monographs and general chapters (more information here). An important step forward in the harmonisation effort has been achieved recently for a number of texts. New sign-offs Numerous texts...
Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components
Messenger RNA (mRNA) vaccines have been at the forefront of vaccine development efforts during the COVID-19 pandemic. With two authorised mRNA-based vaccines on the market, the mRNA vaccine field continues to evolve, as this increasingly important technology can be tailored to fight different...
11 November 2024
Public holiday: EDQM offices closed on 11 November 2024
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on 11 November 2024.
Normal business hours will resume on 12 November 2024.
1 November 2024
Public holiday: EDQM offices closed on 1 November 2024
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on 1 November 2024.
Normal business hours will resume on 2 November 2024.
Certification monthly report of activities: End of April 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2023 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standard and 18 replacement batches released in April 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...
Remote and online provision of medicines: EDQM targeted stakeholder consultation
From 13 March to 26 May 2023, 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 Council of Europe recommendation on best practices for the remote and online provision of medicines....
Requirements for the content of the CEP dossier according to the CEP 2.0 and updated application forms
As part of the implementation of CEP 2.0 and as of 1 June 2023, the changes to the content of CEP applications listed below will be implemented AND the use of updated application forms will be mandatory. Changes to the CEP dossier content: The CEP dossier, the assessment performed and the...
EDQM publishes 21st edition of the Blood Guide, providing state-of-the-art guidance for healthcare professionals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 21st edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide). The Blood Guide is a compendium of widely accepted, harmonised European technical standards...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 March 2023.
European Pharmacopoeia Supplements 11.3 to 11.5 – 2024 subscriptions now open!
The 2024 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.3 to 11.5, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...
Certification monthly report of activities: End of March 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2023 Certification Monthly Report For more information, access the Certification Database.
CEP holders invited to comment on draft monographs published in Pharmeuropa 35.2
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 35.2. The table below lists the substances...
Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2
At its 170th session (June 2021), the European Pharmacopoeia Commission (EPC) agreed to elaborate a new general chapter, Phage therapy active substances and medicinal products for human and veterinary use (5.31), and assigned the task to the newly created Bacteriophages Working Party (BACT WP)....
Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023
The European Pharmacopoeia Commission (EPC) held its 175th session on 21 and 22 March 2023. The 84 texts adopted by the EPC at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.4 (October 2023), with an implementation date of 1 April 2024. These 84 texts included...
20 replacement batches released in March 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...
European Paediatric Formulary: Clonidine hydrochloride oral solution monograph published for public consultation in Pharmeuropa PaedForm
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 6 of Pharmeuropa PaedForm, in which the draft text for Clonidine Hydrochloride 10 micrograms/mL Oral Solution is published for public consultation with a view to its later inclusion in the European...
MIRCA: An EDQM tool to enhance safe use of substances of human origin
The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently unveiled the Microbiological Risk of Contamination Assessment tool (dubbed “MiRCA”), which aims to improve the safety and efficacy of substances of human origin (SoHO) used for therapeutic purposes. The MiRCA tool,...
Find information on the EDQM's responses to N-nitrosamine contamination and the COVID-19 pandemic.