Achievements
Outreach
Articles published in scientific journals
New EDQM publications
- Guide to the preparation, use and quality assurance of blood components (21st Edition)
- Corneal transplants − All you need to know
- The implementation of pharmaceutical care in daily practice in SEEHN member states. Survey report
- EuroGTP II guide (2nd Edition)
- Variant Creutzfeldt–Jakob disease: deferral criteria for blood donors in European countries
- Safe cosmetics for young children (2nd Edition)
- Guide for the elaboration of monographs on herbal drugs and herbal drug preparations (2nd Edition)
- Fertility preservation: A guide for people facing an illness or life events that may affect their fertility (French translation 2023)
- Tissue donation. Everything you need to know (French translation 2023)
European Pharmacopoeia Commission members and observers (2023)
39 member states
31 observers
New observers in 2023: Egypt and the Kyrgyz Republic
39 member states
5 observer states
3 observer states
2 observer states
8 observer states
10 observer states
1 observer state
EU (member)*
TFDA and WHO (observers)*
*EU: European Union. TFDA: Taiwan Food and Drug Administration. WHO: World Health Organization.
Quality & use of medicines
European Pharmacopoeia
Selected European Pharmacopoeia texts adopted in 2023
- One new general chapter: Comparability of alternative analytical procedures (5.27)
- Two new monographs: Cannabis flower (3028) and Cannabidiol (3151)
Biological Standardisation Programme achievements
Total number of projects
21
Concluded projects
6
Projects still running
15
Standard Terms Database key figures
Registered users
43 000
Individual standard terms concepts
1 076
Entries
31 500
Languages
35
European Paediatric Formulary
PaedForm Online Platform
Activities
Laboratory verification conducted prior to public consultation in 2023, in line with the adapted procedure, for:
- Chloral hydrate 100 mg/mL oral solution (F0010),
- Clonidine hydrochloride 10 µg/mL oral solution (F0018),
- Furosemide 2 mg/mL oral solution (F0003).
The first text was published in the European Paediatric Formulary in October 2023, while the two others are pending adoption by the CD-P-PH.
The PaedF Working Party decided to routinely verify the test methods and the microbiological quality of preparations, where relevant. By confirming the microbiological quality of formulations, in addition to their chemical stability, the European Paediatric Formulary can provide additional backing to unlicensed formulations.
Work Programme 2023
- Amiodarone hydrochloride capsules
- Amiodarone oral solution
- Baclofen oral suspension
- Chloral hydrate rectal solution
- Clonidine hydrochloride oral solution
- Ethambutol hydrochloride oral solution
- Flecainide acetate oral solution
- Furosemide oral solution
- Isoniazid oral solution
- Lorazepam oral solution
- Nifedipine oral liquid
- Pyrazinamide oral suspension
- Simple syrup (with preservatives)
- Valaciclovir hydrochloride oral solution
Possible next candidates for addition to the work programme:
- Amlodipine oral liquid
- Phenytoin oral liquid
- Pyridoxine oral suspension
- Spironolactone oral suspension
Reference standards
Certification of suitability to the European Pharmacopoeia monographs (CEP)
Total valid and issued CEPs in 2023
442
new certificates
1 416
revised certificates
6 310
valid certificates
In 2023 there was a slight reduction in new certificates (down 4%) and revised certificates (down 8%).
There were also a total of 2 400 requests for revision of CEPs (up 10%) and 381 new applications (down 10%).
Finally, the following inspections were conducted in 2023: 26 on-site, 2 RTEMIS and 35 desktop assessments.
Network of Official Medicines Control Laboratories (OMCLs)
EU/EEA specific activities in 2023
Substances of human origin
Organs, tissues and cells
Blood transfusion
Nucleic amplification technique (NAT)
- B-PTS068 HBV/HCV/HIV NAT
Serology
- B-PTS069 Anti-HCV
- B-PTS070 HBsAg/Anti-HBc
- B-PTS071 Anti-Treponema
- B-PTS072 Anti-HIV/p24
Immuno-haematology
- B-PTS073 ABO, Rhesus, extended phenotyping and irregular antibodies
Pharmaceuticals and Pharmaceutical Care
recommendations on the classification of medicines and their supply conditions (prescription and non-prescription status) established by the CD-P-PH/PHO and entered into the Melclass database.
Quality management system
Quality management remains a high priority for the EDQM. In 2023, the EDQM maintained its ISO 9001:2015 certificate following audits from the certification body in February 2023 and in December 2023. In addition, the ISO 17025:2017 accreditation certificate was maintained by the accreditation body following the second surveillance audit held in May 2023. Twenty-one of the EDQM Laboratory’s techniques are covered by this certificate.
The EDQM makes all necessary efforts to continually develop and improve its quality management system. Its customers and interested parties can therefore have faith in the consistent quality of the goods and services provided by the EDQM.
