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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...
Job offer: Junior Scientific Assistant
Grade: B3 Salary: €3 702 per month (gross) Contract Type: Renewable fixed term contract (max 4 years) Location: Strasbourg (France) Reference: Vacancy Notice n° 35/2022 Deadline for applications: 06/10/2022 Are you a young scientist eager to gain experience in an international Organisation that...
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...
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...
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,...
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...
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...
Job Offer: Accounting and Financial Assistants
Grade: B1/B2 Salary: from €2 829 (grade B1) or €3 224 (grade B2)¹ per month (gross) Contract Type: Renewable fixed term contract Location: Strasbourg (France) Reference: Vacancy Notice n° e33/2022 Deadline for applications: 29/09/2022 Would you like to join a committed team contributing to the...
Job offer: Financial Assistant - Assets
Grade: B4 Salary: €4 225 (grade B4)¹ per month (gross) Contract Type: Renewable fixed term contract Location: Strasbourg (France) Reference: Vacancy Notice n° e32/2022 Deadline for applications: 26/09/2022 Do you have proven finance and accounting skills? Are you a stickler for detail and...
Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), described as plastic additive 01 in Ph. Eur. general chapter 3.1.14....
11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version. Don’t delay, order your subscription now! This latest edition contains numerous revised and new texts, reflecting the latest scientific and technological progress and regulatory developments in the...
Call for experts: join the Ph. Eur. network
Pharmaceutical analytical procedures related to quality control methods for antibiotics
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The European Pharmacopoeia Commission elects its two new Vice Chairs
The European Pharmacopoeia (Ph. Eur.) Commission is pleased to announce the nomination of two new Vice Chairs, elected at its 173rd session held on 22 and 23 June 2022. Dr Eugenia Cogliandro (first Vice Chair) and Dr Marija Malesevic (second Vice Chair), replace outgoing Vice Chairs Prof. S....
Certification monthly report of activities: End of July 2022
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.
Ph. Eur. Commission establishes a new working party on mRNA vaccines
At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...
3 new Ph. Eur. reference standards and 23 replacement batches released in July 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...
General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition
General chapter 2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the...
Call for experts: join the Ph. Eur. network
Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products
Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online
Following the adoption of batch 4 of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for human immunoglobulin for electrophoresis by the Ph. Eur. Commission, the outcome of the establishment study has been published in Pharmeuropa Bio & Scientific Notes, a freely...
15 replacement batches released in June 2022
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 order The European Directorate for...
Draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells
On 14 July 2022, the European Union (EU) Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC), in which the EU Commission proposes to leverage on the technical standards and proven expertise of the European Centre for Disease Prevention and...
EDQM publishes 8th edition of the Guide to the quality and safety of organs for transplantation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 8th edition of the Guide to the quality and safety of organs for transplantation. The updated guide provides practical guidance to all professionals in the field, as well as technical guidance to...
Certification monthly report of activities: End of June 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of June Certification Monthly Report For more information, access the Certification Database.
What’s new for homoeopathic preparations at European level?
First revision of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022) As announced in the press release dated 11 April 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved the revised version of the Guide for the elaboration of monographs on...
EDQM closure Thursday 14 July 2022
Due to a public holiday in France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed on Thursday 14 July 2022. Normal office hours will resume on Friday 15 July 2022.
Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022
The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...
New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication
At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a...
Pharmeuropa 34.3 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 34.3 is 30 September 2022. Users and interested parties are welcome to comment on these drafts. It...
Implementation of the 11th Edition of European Pharmacopoeia – Notification for CEP holders
The 11th Edition 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 2023, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.3
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 34.3. The table below lists the substances...
Revision of Heparin sodium (0333) and Heparin calcium (0332) monographs – feedback required
First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions...
OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines
The 27th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) was held from 13 to 17 June 2022 at the Council of Europe, in Strasbourg (France). Over 230 participants – from 36 countries and representing 60 OMCLs – attended this meeting organised by the...
Pharmacopoeial Discussion Group videoconference meeting
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia with WHO as observer, held its interim videoconference in two sessions on 15 and 28 March 2022. During this videoconference, the PDG discussed...
BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...
Call for experts: join the Ph. Eur. network
Quality control of inorganic substances and synthetic and semi-synthetic organic substances
EDQM ISO 9001:2015 certification renewed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....
NEW 5th European Training Course on Quality Management for Blood Establishments
The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe (CoE) is organising a FREE training course on audit practices for blood establishments, with the support of the European Commission. Auditing, in addition to being a key driver in the continual improvement...
Pharmeuropa Bio & Scientific Notes now accessible without registration
Pharmeuropa Bio & Scientific Notes, a free online journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM) indexed in Medline/PubMed®, can be consulted without prior registration as of 13 June 2022. The journal seeks to disseminate knowledge on methods of analysis...
2021 Highlights – EDQM annual report now available
Download: 2021 Highlights – EDQM annual report The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities and achievements. New to this edition is a four-page summary of key facts and...
New option for shipments to Ukraine and the Republic of Moldova
The EDQM is now able to offer a new option for shipments to Ukraine and the Republic of Moldova. Ukrainian and Moldovan users will receive a dedicated e-mail explaining how to proceed. If you would like more information, please contact us through our HelpDesk.
Certification monthly report of activities: End of May 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of May Certification Monthly Report For more information, access the Certification Database.
16 replacement batches released in May 2022
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 Medicines...
OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...
Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs
8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...
Temporary job offer: Assistant
Salary: from €2 460 (netto/month) Contract type: temporary (until end of 2022, renewable in 2023) Place: Strasbourg (France) We're looking for several individuals to operate secretarial duties, highly motivated and who can quickly slot in to our existing structure and immediately operate...
Call for experts: join the Ph. Eur. network!
The European Pharmacopoeia (Ph. Eur.) is seeking independent scientific experts to join its groups of experts and working parties. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the...
Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs). The adoption of...
European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!
The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...
Certification monthly report of activities: End of April 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.
New BSP study publication: Heparin Low-Molecular-Mass for Assay BRP
An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 is now available online. The article has been published in Pharmeuropa...
24 replacement batches released in April 2022
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 EDQM announces the release of: 24 replacement...
New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates
At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form. This policy differentiates between hydrates, which have...
New OCABR guideline on inactivated COVID-19 vaccines
The new Official Control Authority Batch Release (OCABR) “Guideline for Pandemic COVID-19 Vaccine, Inactivated”, containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 4 May 2022. The availability of...
Council of Europe adopts recommendation on developing and optimising programmes for the donation of organs after the circulatory determination of death
The Committee of Ministers of the Council of Europe adopted Recommendation CM/Rec(2022)3 on the development and optimisation of programmes for the donation of organs after the circulatory determination of death in February 2022. Each year thousands of patients die or endure poor quality of life...
New general text on comparability of alternative analytical procedures: European Pharmacopoeia launches public consultation
The European Pharmacopoeia (Ph. Eur.) at the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on its new general text on the comparability of alternative analytical procedures (5.27). The draft text elaborates on the requirement expressed more succinctly...
New Pharmeuropa Bio & Scientific Notes article now online: Human immunoglobulin for ACA BRP
A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022. Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human...
Proceedings of Workshop on alternatives to animal testing in Quality Control of Veterinary Vaccines now available
The proceedings of the workshop "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" have been published in FreePub, a free online EDQM journal. The event, held in March 2021, was jointly organised by the European Directorate...
EDQM sticker no longer to appear on Certificates of suitability
As of the 1 May 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) sticker will no longer appear on Certificates of suitability to the European Pharmacopoeia monographs (CEPs). This adhesive sticker (see picture) will no longer be pasted on CEPs next to the wet...
European Pharmacopoeia 11th Edition International Conference: early-bird registration now available
Registration is now open for the international conference to mark the launch of 11th Edition of the European Pharmacopoeia (Ph. Eur.). The conference will take place from 19 to 21 September 2022, both in-person, in Strasbourg (France), and virtually. The main themes of the conference are...
Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022
The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd session on 22 and 23 March 2022. The Commission adopted 78 texts at this session, to be published in Ph. Eur. Supplement 11.1 and be effective as of 1 April 2023. These 78 texts included six new monographs and one new general...
Certification monthly report of activities: End of March 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2022 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. Commission elects its new Chair at 172nd Session
The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd Session on 22 and 23 March 2022. Among other decisions, the Commission elected its new Chair, Professor Salvador Cañigueral. Professor Cañigueral has been first Vice-chair to the Commission since June 2019. He will take up his duties...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.2
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 34.2. The table below lists the substances...
EDQM helping increase tissue donation thanks to a better understanding of post-mortem blood testing practices
Tissue from one deceased donor may be transplanted into as many as 100 individuals, improving their quality of life and even saving their lives (e.g. in the treatment of catastrophic burns). However, the use of tissues of human origin can result in unintentional transmission of disease. Such...
Tools to support contingency and emergency planning for blood systems
In emergency situations, it is vital to ensure a safe and adequate supply of blood for all essential transfusions. Join our Webinar to learn more! The Blood Supply Contingency and Emergency Plan (B-SCEP) Project was launched by the European Directorate for the Quality of Medicines & HealthCare...
13 replacement batches released in March 2022
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...
New EDQM website, redesigned to better serve your needs – Now online!
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...
Pharmeuropa 34.2 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 34.2 is 30 June 2022. Users and interested parties are welcome to comment on these drafts. It should be...
Metals and alloys used in food contact materials and articles: updated technical guide released for consultation
The 1st edition of the technical guide “Metals and alloys used in food contact materials and articles” (2013) has been completely reviewed by the European Committee for Food Contact Materials and Articles (Partial Agreement) (CD-P-MCA) to account for regulatory developments and recent risk...
Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections
The experts of the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidisable substances by the test for total organic carbon (TOC) in the Tests section of the “Sterilised water for injections” part of the monograph on Water for injections (0169). This change has been...
EDQM event "Quality requirements for nanomedicines"
The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations – especially lipid-based systems – used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes around the globe has demonstrated that these...
Certification monthly report of activities: End of February 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2021 Certification Monthly Report For more information, access the Certification Database.
Full OCABR Guideline for Pandemic COVID-19 vaccine (Recombinant Spike Protein) now available
The Pandemic COVID-19 vaccine (Recombinant Spike Protein) guideline, in force since 30 November 2021, 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 been updated to include a model...
SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)
After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...
20 replacement batches released in February 2022
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...
Suspension of shipments
Due to the recent events in Ukraine, all carriers have suspended their activities in Belarus, Moldova, Russia and Ukraine until further notice. Therefore, the EDQM can no longer proceed with any shipments for Reference Standards, Publications or PTS to these countries.
Update of application forms for Certificate of Suitability applications
The forms for the submission of Certificate of Suitability to the European Pharmacopoeia monographs (CEP) applications (new applications, revisions and sister files) have been updated in order to facilitate their handling and the transfer of the collected data in the new IT tools implemented at...
PHARMEUROPA BIO & SCIENTIFIC NOTES publication – Weighing according to the European Pharmacopoeia
An article on weighing according to the European Pharmacopoeia has been published in Pharmeuropa Bio & Scientific Notes and is referenced in Medline/PubMed®. Weighing is a key activity in every quality control laboratory as it is one of the first steps in the preparation of samples and reagents...
EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme!
In March 2020 travel restrictions, designed to minimise the spread of SARS-CoV-2, interrupted the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which monitors compliance with both Good Manufacturing Practice (GMP) and applications for...
Webinar: How to communicate efficiently with the EDQM on CEP applications
In October 2021, the CEP Department of the EDQM started using a new IT application for the management of its activities. The implementation of this new tool entailed specific changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia...
New Webinar: What has changed in the Ph. Eur. General Notices?
The General Notices is the European Pharmacopoeia (Ph. Eur.) go-to chapter that contains important information applicable to all Ph. Eur. texts. Its content is relevant for any user seeking to understand not just the conventional expressions and terminology used throughout the Ph. Eur. but also...
Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques
At its 171st session in November 2021, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new version of one of its widely used general chapters, Chromatographic separation techniques (2.2.46). The text has been revised to take account of the pharmacopoeial harmonisation text, signed-off...
Certification monthly report of activities: End of January 2022
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. January 2022 Certification Monthly Report For more information, access the Certification Database.
Ph. Eur. tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances – End of trial period postponed
When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS. The trial period for this policy has been prolonged until the end of February 2023,...
EDQM reminds CEP holders of their responsibilities towards their customers
CEP holders have obligations towards the marketing authorisation holders in order to enable them to fulfil their respective legal responsibilities. Recent issues have demonstrated the lack of knowledge of some CEP holders regarding those obligations. In order to clarify the issue, EDQM has...
2 new reference standard and 19 replacement batches released in January 2022
New Ph. Eur. reference standards 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...
EDQM OCCL study reports low compliance of “kids’ cosmetics”
A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that “kids’ cosmetics” continue to fail to comply with European quality and safety regulations, finding that 25% of samples were non-compliant with legislative requirements. Decorative cosmetics,...
How to use the EDQM DCEP sharing tool
The EDQM DCEP sharing tool is a new IT tool used to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. Specific instructions are given to the intended users for the creation and the...
Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders
Supplement 10.8 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 2022, and to follow the...
CEP holders invited to comment on draft monographs published in Pharmeuropa 34.1
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 34.1. The table below lists the substances...
European Paediatric Formulary: two draft texts released for public consultation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric...
Find information on the EDQM's responses to N-nitrosamine contamination and the COVID-19 pandemic.