EDQM facts and figures for 2025
Global outreach and impact
Quality & use of medicines
European Pharmacopoeia
texts published in Pharmeuropa
Ph. Eur. work programme
Selected EPC session highlights
EPC adopts total organic carbon (TOC) as a modern, more sensitive test than the oxidisable substances test for ensuring the purity of sterilised water for injections.
Appointment of over 1 000 experts and chairs for more than 60 groups of experts and working parties for the next three-year term (2025-28).
Bacterial endotoxin testing in the European Pharmacopoeia: another milestone in offering sustainable alternatives to horseshoe crab reagents.
Biological Standardisation Programme achievements
Total number of projects
26
Concluded projects
2
Projects still running
24
Standard Terms Database key figures
Registered users
50 000
Individual standard terms concepts
1 099
Entries
32 200
Languages
35
Visitors
36 000
Sessions
95 000
Page views
380 000
European Drug Shortages Formulary
The EDQM set up the European Drug Shortages Formulary Working Party (EDSForm WP) in 2024 and launched the Pharmeuropa EDSForm platform in October 2025.
Public consultations in 2025
- Amoxicillin capsules monograph
- Introduction to the European Drug Shortages Formulary
- General principles of the European Drug Shortages Formulary
Seven other texts are currently on the work programme.
European Paediatric Formulary
PaedForm Online Platform
Activities
Practical evaluation of three monographs
- Ethambutol oral suspension (F0012)
- Amiodarone oral suspension (F0024)
- Amlodipine oral liquid (F0027)
New monographs published for public consultation
- Isoniazid oral solution (F0005)
- Lorazepam oral solution (F0014)
Monographs added to the work programme
- Phenytoin oral liquid (F0031)
- Nifedipine oral solid (F0032)
Work programme 2025
- Amiodarone oral solution (F0024)
- Amlodipine oral liquid (F0027)
- Azathioprine oral suspension (F0004)
- Chloral hydrate rectal solution (F0016)
- Ethambutol hydrochloride oral suspension (F0012)
- Flecainide acetate 2mg/mL oral solution (F0017)
- Lorazepam oral solution (F0014)
- Midazolam nasal spray (F0019)
- Nifedipine oral liquid (F0025)
- Nifedipine oral solid (F0032) (New)
- Omeprazole oral suspension (F0009)
- Phenytoin oral liquid (F0031)
- Prednisolone oral liquid (F0028)
- Pyrazinamide oral liquid (F0013)
- Pyridoxine oral liquid (F0030)
- Spironolactone oral liquid (F0026)
- Vehicle for oral solution or suspension, preserved (F0020)
- Warfarin oral liquid (F0029)
Reference standards
Certification of suitability to the European Pharmacopoeia monographs (CEP)
Total valid and issued CEPs in 2025
539
new certificates
1 742
revised certificates
>7 200
valid certificates
There was a noticeable decline in certificates issued (down 7%) in 2025, but the number of revised certificates increased slightly (up 1%).
Requests for a revision to CEPs increased to 2 630 (up 11%), and the number of new applications grew at a similar rate, i.e. up 12% (to 525).
Although no real-time remote inspections (RTEMIS) took place during 2025, the total number of inspections that were conducted during the year was higher than in 2024. Overall, inspection activities continue to grow, with 37 on-site inspections (compared to 30 in 2024) and 96 desktop assessments (79 in 2024).
Network of Official Medicines Control Laboratories (OMCLs)
The OMCL Network general activities
30th GEON Annual Meeting
The 30th Annual Meeting of the GEON took place in Oslo (Norway) from 19 to 23 May 2025, bringing together over 250 participants from 61 official medicines control laboratories (OMCLs) from 41 countries. The event was hosted by the Norwegian Medical Products Agency (NOMA).
EU/EEA specific activities in 2025
OCABR – Surveillance of biologicals for human use
Market surveillance programmes
CAP regular programme
CAP generics programme
MRP/DCP programme
projects
Substances of human origin
Organs, tissues and cells
Network of National Focal Points on Travel for Transplantation (NETTA)
9th technical meeting of NETTA
The 9th technical meeting of NETTA (12-13 June 2025) advanced the network’s ongoing work to monitor and analyse international travel for transplantation, promoting ethical practice and ensuring the protection of donors and recipients.
Registry of International Travel for Transplantation Activity (RITTA)
CD-P-TO position papers
Blood transfusion
B-PTS programme
*Calculation of the average number of participants does not take into account the study on bacterial testing of platelet components since it was the first full-fledged study of this kind.
B-PTS studies conducted
Nucleic Amplification Technique (NAT)
- B-PTS081 Bacterial testing of platelet components
- B-PTS082 HBV/HCV/HIV NAT
Serology
- B-PTS083 Anti-HCV
- B-PTS084 HBsAg/Anti-HBc
- B-PTS085 Anti-Treponema
- B-PTS086 Anti-HIV/p24
Immuno-haematology
- B-PTS087 ABO, Rhesus, extended phenotyping and irregular antibodies
B-QM programme
B-QM assessments conducted
On-site
- B-MJV033, MJV, Hospital blood bank
- B-MJV034, MJV, Blood establishment
- B-MJV036, MJV, Hospital blood bank
- B-MJV039, MJV, Blood establishment
- B-TV015, TV, Hospital blood bank
Virtual
- B-TES003, Tailored Expert Support Scheme, Blood establishment
Pharmaceuticals and Pharmaceutical Care
The CD-P-PH/PHO has made 89 recommendations on the classification of medicines and their supply conditions (prescription or non-prescription status), which have been entered into the Melclass database.
Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)
These new guidelines introduce a new approach by CD-P-PH/PHO for assessing medicines with a view to their classification. They are intended to help all interested parties establish whether a medicinal product should be available with or without a prescription, representing a decision that is dependent on several factors.
Herbal food supplements
A guide on herbal food supplements that targeted healthcare professionals and a similar leaflet for consumers were published to provide healthcare professionals with structured, practical recommendations and enable consumers to make informed choices.
The plenary meeting of this network was held in Warsaw (Poland) on 4 and 5 March 2025. A dedicated session on substances of human origin (SoHO) took place, in which the European Commission’s DG SANTE participated.
Melclass database
The Melclass database contains the legal classification of medicines regarding their supply conditions and details of prescription/non-prescription status. Biannual updates were carried out in 2025, and 3 058 users consulted the database (33 462 page views).
Consumer health protection
Cosmetics
16th meeting of the European OCCL Network
The Croatian Institute of Public Health (HZJZ) hosted the 16th meeting of the European Network of Official Cosmetics Control Laboratories (OCCLs) on 7 and 8 October 2025 in Zagreb (Croatia). The meeting brought together 45 participants from the national authorities of 27 countries, who attended either in person or online.
Cosmetics and the green transition
The Croatian Society of Cosmetic Chemists, HZJZ, and the Croatian Chamber of Economy jointly hosted a regional event on cosmetics and the green transition in Zagreb (Croatia) in October 2025.
Studies
COS PTS 026
Determination of hydrogen peroxide in cosmetics; 27 participants from 19 countries (completed)
COS PTS 027
Identification and determination of precursors of oxidative hair colorants; 14 participants from 12 countries (in progress, due for completion in 2026)
COS MSS 002
Cosmetic products for children, 4th round (in progress)
COS MSS 006
Nitrosamines in nail varnishes (in progress)
Food contact materials
12th meeting of the EFSA FCM Network
The EFSA FCM Network is an important platform for co-operation on risk-assessment activities and harmonisation of risk-assessment methodologies, enabling member states to share their expertise and find opportunities for collaboration. This meeting, held from 21 to 23 October 2025 in Parma (Italy), brought together 26 EU member states, two EFTA member states (Norway and Switzerland), the Council of Europe/EDQM, the European Chemicals Agency (ECHA), and the European Commission’s DG SANTE and Joint Research Centre.
Cork materials and articles for contact with food
This technical guide prepared by the CD-P-MCA aims to ensure the safety and suitable quality of food contact materials and articles made from cork. It presents scientific information, recommendations for compliance testing and features a list of evaluated substances used in the manufacture of cork materials and articles.
Outreach
EDQM events
Webinars
- Medication reviews in Europe and their role in optimising the use of medicines by patients
- Sterile substance CEPs
- Unlocking the potential of the European Pharmacopoeia Online
- Joint EDQM–USP Webinar on “Orthogonal Analytical Methods for the Characterisation of Pharmacopoeial Reference Standards”
- How to read a CEP
Conferences, symposiums, meetings, workshops, etc.
- EDQM Blood Conference
- EDQM Plasma Supply Continuity – Stakeholder Event
- Certified for success: using the CEP Procedure to elevate quality and drive trust
- 30th GEON annual meeting
- 16th OCCL Network meeting
- European Pharmacopoeia 12th Edition launch event
- Council of Europe Conference on Health Protection
Full information on EDQM events is available on our “Events & training” page.
Participation
The EDQM also participated in the following external events:
- European Association of Hospital Pharmacists (EAHP) 2025 Congress
- European Health Management Association (EHMA) 2025 Conference
- International Pharmaceutical Federation (FIP) 2025 World Conference
- European Society of Clinical Pharmacy (ESCP) 2025 Symposium
- EU Heads of Medicines Agencies’ Working Group of Enforcement Officers (HMA-WGEO), 37th & 38th meetings
- International Society of Blood Transfusion (ISBT) Congress, Milan (Italy), 1-4 June 2025
- One World, One Blood – International Cooperation in Transfusion Medicine Conference, Bologna (Italy), 15 October 2025
- TAIEX Multi-country Workshop on the implementation of the new EU Regulation on substances of human origin (SoHO), Brussels (Belgium), 19-20 November 2025
- SoHO oversight system: the implementation of the new EU Regulation with a focus on the obligations for competent authorities, 8 April 2025, Rome (Italy)
- Medicine Shortages Single Point of Contact Working Party meeting, Amsterdam (Netherlands), 14 and 15 October 2025
- Drug Information Association Europe 2025
- CPhI Worldwide, Frankfurt (Germany), October 2025
- CPhI China & CCCMPHIE Symposium
Training sessions
EDQM Virtual Training Programme
Independent training modules on the Ph. Eur., reference standards and the CEP Procedure
- Module 1: General methods, general chapters and general monographs
- Module 2: Individual monographs - Focus on chemically defined active substances and medicinal products containing them
- Module 3: Impurity control in the Ph. Eur.
- Module 4: Ph. Eur. reference standards
- Module 5: Fundamentals of the CEP Procedure
- Module 6: Building successful CEP dossiers: new applications
- Module 7: Building successful CEP revision applications
- Module 8: Control of impurities: CEP approach
- Module 9: The EDQM inspection programme
CombiStats training
Two sessions were conducted in 2025
EDQM On Air podcast
EDQM On Air is a podcast on public health brought to you by the EDQM. Tune in for expert insights, engaging discussions and inspiring stories to discover how, together with our stakeholders, we are safeguarding public health through our work in medicines, pharmaceutical care, substances of human origin and consumer health.
A win for animals – Phasing out the rabbit pyrogen test
Discover how viable, modern alternatives made it possible to remove the decades‑old rabbit pyrogen test from the European Pharmacopoeia.
COVID-19 – Rising to the challenge of a global crisis
How did the EDQM’s extensive networks of experts, partners and stakeholders contribute to the fight against COVID-19?
AI in public health – Innovations, ethics and the road ahead, with Eric Sutherland
Artificial intelligence is a source of both great hope and concern in healthcare. How can we realise its potential and avoid the inherent risks?
The OMCL Network – A story of collaboration for safe and good quality medicines
This episode highlights the story of collaboration built through the years by the OMCL Network, ensuring the safety and quality of medicines.
The evolution of biologicals in the European Pharmacopoeia
Find out how biological medicinal products have evolved, highlighting work on vaccines, cell‑based products and molecular techniques.
Articles published in scientific journals
EDQM publications in 2025
- Guide to the preparation, use and quality assurance of blood components, (22nd edition)
- Guide pour la préparation, l’utilisation et l’assurance qualité des composants sanguins, 22e édition
- Guide to the quality and safety of organs for transplantation, 9th edition
- The collection, supply and use of blood and blood components in Europe (2020-2023)
- Newsletter Transplant, volume 30
- Add-ons in medically assisted reproduction treatments – A guide for those seeking fertility care
- Orientations sur la revue de médication (French edition 2025, English edition 2024)
- Herbal food supplements – Guide for healthcare professionals
- Herbal food supplements – Leaflet for consumers – Understanding herbal food supplements
- Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)
- Cork materials and articles for contact with food – A technical guide for manufacturers and regulators