Newsroom
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...
SAVE THE DATE! Joint USP-EDQM Symposium on "Pharmaceutical Reference Standards"
The USP is pleased to announce it is co-organising a symposium with the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, entitled “Pharmaceutical Reference Standards”. It will take place in Rockville, Maryland (USA) from 27 to 28 September 2023....
Summer job: Student skilled in chemistry
Are you a student and free this July and August? The EDQM is looking for a student skilled in chemistry (minimum two years of studies at university or engineering school) to build a database for our reference standards in order to comply with new European environment regulations. You must: have a...
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...
Head of Division – Substances of Human Origin
Do you have the managerial skills, scientific experience, enthusiasm and drive required to lead a team of scientists and administrative staff implementing an ambitious work programme that helps to ensure donor and recipient safety across Europe?
International call for tenders for the procurement of active pharmaceutical ingredients to be used for the establishment of Ph. Eur. reference standards
The European Directorate for the Quality of Medicines & HealthCare (EDQM), a Directorate of the Council of Europe, has launched an international call for tenders (2023AO39) for the procurement of active pharmaceutical ingredients to be used for the establishment of European Pharmacopoeia (Ph....
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,...
CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications
As part of the implementation of the CEP 2.0, it will be mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers....
Certification monthly report of activities: End of February 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2023 Certification Monthly Report For more information, access the Certification Database.
1 new Ph. Eur. reference standards and 15 replacement batches released in February 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 See also: Content of the Ph. Eur. RS catalogue How...
European Pharmacopoeia Commission creates new Excipients Strategy Working Party
During its 173rd session in June 2022, the European Pharmacopoeia Commission (EPC) approved the creation of a new Excipients Strategy Working Party (EXS) (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The EXS Working Party will focus on continuing to...
Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts
As announced in the press release on 6 January 2023, the Pharmacopoeial Discussion Group (PDG) held its annual autumn meeting on 18-21 October 2022. In attendance were the three established members of the PDG – the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United...
The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Partnership for Alternative Approaches to Animal Testing (EPAA) have just held a highly successful three-day joint event aimed at phasing out the rabbit pyrogen test (RPT) from the testing of...
Independent control of COVID-19 vaccines: article co-authored by the EDQM and members of the OCABR Network published in npj Vaccines
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and members* of the Official Control Authority Batch Release (OCABR) Network of the General European OMCL Network (GEON) have co-authored an article entitled “Independent Control of COVID-19 Vaccines by EU Official Control...
Shutdown of European Pharmacopoeia 10th Edition
The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. Consequently, the 10th Edition online and all previous versions, including the Ph. Eur. archives for 10th Edition clients, have no longer been accessible since 31 January 2023. The Ph. Eur. 11th Edition and...
Public consultation on Ph. Eur. rabbit pyrogen test replacement texts in Pharmeuropa 35.1
The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1, with a commenting deadline of 31 March 2023. These...
Ph. Eur. Commission establishes a dedicated working party on High Throughput Sequencing
At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to create a new Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents. Also known as NGS, this advanced...
24 replacement batches released in January 2023
Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units 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 order The European Directorate for the Quality of...
Certification monthly report of activities: End of January 2023
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2023 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures
The European Pharmacopoeia (Ph. Eur.) contains quality standards that are applied in a constantly evolving environment and it is therefore essential that its texts and the procedures they describe consistently reflect current practices. As is the case for any other text, where procedures relating...
SNOMED International and the EDQM collaborate on map development
SNOMED International and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement governing the creation, maintenance and distribution of a map between both organisations’ terminologies. The agreement came into effect in September...
CEP holders – How to submit a nitrosamine risk assessment
To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Minor revisions should be submitted for revised...
European Paediatric Formulary: Simple syrup (preservative-free) monograph published
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Simple syrup (preservative-free), to the European Paediatric Formulary. The monograph was published in Issue 4 of Pharmeuropa PaedForm in January 2022, approved by the European Pharmacopoeia...
Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders
Supplement 11.2 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 2023, and to follow the...
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...
Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022
The European Pharmacopoeia Commission (EPC) held its 174th session on 22 and 23 November 2022. The 85 texts adopted by the Commission at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023), with an implementation date of 1 January 2024. These 85 texts...
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...
Pharmacopoeial Discussion Group achievements
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as observer, held its annual autumn meeting from 18 to 21 October 2022. Due to...
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...
Certification monthly report of activities: End of December 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of December Certification Monthly Report For more information, access the Certification Database.
Pharmeuropa 35.1 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 35.1 is 31 March 2023.
Information for CEP applicants - EDQM-DCEP non-working days in 2023
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,...
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...
European Pharmacopoeia Supplement 11.2 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.2 is now available and will be applicable in 39 European countries as of 1 July 2023. This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...
EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 5th edition of the Guide to the quality and safety of tissues and cells for human application. The updated guide provides a comprehensive overview of the most recent advances in the field, as well as...
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.
Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)
The revised general chapter Chromatographic separation techniques (2.2.46) was published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.) in the framework of international harmonisation. This new version (due to be implemented on 1 January 2023) includes many important changes. One of...
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...
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...
EDQM order and shipment deadlines and end-of-year closure
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 22 December 2022 (12 noon CET) to 2 January 2023 (8 a.m. CET). The dates by type...
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...
The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin
The Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union (EU), through the European Commission, have concluded a new contribution agreement, with equal financing, which will run until 2024. This agreement further enhances their already...
“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...
General chapter 2.2.46. Chromatographic separation techniques: comparison of requirements in the Ph. Eur. 10th and 11th Editions
A new document has been added to the Knowledge database page for revised general chapter 2.2.46, under Additional information. This document provides a useful and easy reference guide to the main changes made to the general chapter recently published in the 11th Edition of the European...
Ph. Eur. publishes key harmonised monographs on Paraffin, white soft and Paraffin, yellow soft
The recently published (July 2022) 11th Edition of the European Pharmacopoeia (Ph. Eur.) includes the two revised harmonised monographs Paraffin, white soft (1799), and Paraffin, yellow soft (1554). The publication of these two texts marks an important step forward in the international...
Pharmeuropa 34.4 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 34.4 is 31 December 2022. Users and interested parties are welcome to comment on these drafts. It should...
Certification monthly report of activities: End of September 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of September Certification Monthly Report For more information, access the Certification Database.
The EDQM participated in a conference on Next Generation Sequencing
On 27-28 September, representatives of the EDQM participated in the 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals organised by the International Alliance for Biological Standardization (IABS) in Rockville, Maryland, U.S.A. At the...
European Day for Organ Donation and Transplantation 2022 – Become an “influencer for life” and share what’s most precious
In recent years, great strides have been made in the field of organ, tissue and cell transplantation and human application, making it one of the great medical success stories of modern times. Transplantation is in many cases the only viable treatment for reclaiming essential functions and...
EDQM publishes booklet on human tissue donation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a booklet on the important matter of human tissue donation. It provides clear, accurate and balanced information to help readers make informed, responsible decisions on tissue donation, in accordance with...
4 new Ph. Eur. reference standards and 16 replacement batches released in September 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...
Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia
The revised general chapter, Chemometric methods applied to analytical data (5.21), has just been published in Supplement 11.1 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its 172nd Session in March 2022. Published for information, this general...
DCEP Sharing tool user guide revised
The EDQM DCEP Sharing Tool was launched in January 2022 to ensure that EDQM documents could be shared securely between its Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. This new version of the guide to creating and managing user accounts...
Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders
Supplement 11.1 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 2023, and to follow the...
European Pharmacopoeia 11th Edition conference outcomes
Organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Pharmacopoeia 11th Edition Conference, “Collaboration, Innovation and Scientific Excellence”, took place in Strasbourg from 19 to 21 September 2022. Held in hybrid format, the event brought...
Council of Europe takes steps to support self-sufficiency in tissues and cells for human application and facilitate sharing of knowledge in this field
The Committee of Ministers of the Council of Europe has adopted a recommendation encouraging member states to harmonise the collection of data on the availability and use of tissues and cells according to a predefined set of parameters and definitions. This text aims to support self-sufficiency...
Newsletter Transplant 2022 shows a global increase in donation and transplantation figures, lessons learnt from COVID-19 pandemic
The latest edition of the Newsletter Transplant – the international reference in monitoring practice in donation and transplantation of substances of human origin – has just been published. It provides comprehensive information and data on donation and transplantation activities in 2021 from 79...
European Pharmacopoeia Supplement 11.1 now available
The European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available and will be applicable in 39 European countries as of 1 April 2023. This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for online and/or print versions are...
Become an “influencer for life”: 2022 edition of the European Day for Organ Donation and Transplantation encourages people to share what’s most precious
The 2022 edition of the European Day for Organ Donation and Transplantation (EODD) will be hosted by Poland on 8 October 2022. The European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe has sponsored EODD in a different country every year since 1996. The...
Indian Pharmacopoeia Commission to be represented at EDQM international conference in Strasbourg
The Indian Pharmacopoeia Commission (IPC) will take part in the international conference entitled “Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition”, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and to take...
Call for experts: join the Ph. Eur. network
Quality control methods for biological and biotechnological substances and products
Certification monthly report of activities: End of August 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of August Certification Monthly Report For more information, access the Certification Database.
PDG welcomes Indian Pharmacopoeia Commission to pilot for global expansion
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is delighted to welcome the Indian Pharmacopoeia Commission...
New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques
Following queries received from users through the EDQM HelpDesk, new FAQs on the application of revised general chapter 2.2.46. Chromatographic separation techniques (11.0) has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This is...
Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available
The Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines. The update includes a revision of the list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for Official Control...
Stakeholder consultation – Draft guidelines for medication review
From 20 July to 23 September 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking the opinions of stakeholders on its draft guidelines for medication review. This consultation targets international organisations active in public health and social matters,...
2 new Ph. Eur. reference standards and 5 replacement batches released in August 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...
European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021. This new general chapter describes a bacterial endotoxins test (BET) that can be used as an alternative to...
New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia
A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its session in November 2021. This new general text elaborates on the requirement...
Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)
The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required...
Find information on the EDQM's responses to N-nitrosamine contamination and the COVID-19 pandemic.