Table of abbreviations

TERMDESCRIPTION
3R principlesreplacement, reduction and refinement (animal testing)
AIartificial intelligence
AMAAfrican Medicines Agency
AMQFAfrican Medicines Quality Forum
AMRHAfrican Medicines Regulatory Harmonisation
ANSMFrench National Agency for Medicines and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé)
APIactive pharmaceutical ingredient
ASMFActive Substance Master File
ATDanti-tampering device
B-MJVBlood Mutual Joint Visit
B-PTSBlood Proficiency Testing Scheme
B-QMBlood Quality Management Programme
BRPbiological reference preparation
BSPBiological Standardisation Programme
B-TESBlood Tailored Expert Support
B-TVBlood Training Visit
CAPcentrally authorised product
CAS numberChemical Abstracts Service Registry number
CD-P-COSEuropean Committee for Cosmetics and Consumer Health
CD-P-MCAEuropean Committee for Food Contact Materials and Articles
CD-P-PHEuropean Committee on Pharmaceuticals and Pharmaceutical Care
CD-P-PH/CMEDCommittee of Experts on Minimising the Public Health Risks Posed by Falsification of Medical Products and Similar Crimes
CD-P-PH/PCCommittee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care
CD-P-PH/PHOCommittee of Experts on the Classification of Medicines as Regards their Supply
CD-P-TOEuropean Committee on Organs, Tissues and Cells
CD-P-TSEuropean Committee on Blood Transfusion
CEPCertificate of Suitability to the European Pharmacopoeia monographs
CLPRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
COS MSScosmetics market surveillance study
COS PTScosmetics proficiency testing scheme
COVID-19coronavirus disease
CRSchemical reference substance
DCDdonation after circulatory death
DCPdecentralised procedure
DG SANTEDirectorate General for Health and Food Safety
DMFDrug Master File
DNAdeoxyribonucleic acid
EAHPEuropean Association of Hospital Pharmacists
ECHAEuropean Chemicals Agency
EDAEgyptian Drug Authority
EDDEuropean Donation Day
EDQMEuropean Directorate for the Quality of Medicines & HealthCare
EDSFormEuropean Drug Shortages Formulary
EDSForm WPEuropean Drug Shortages Formulary Working Party
EEAEuropean Economic Area
EFSAEuropean Food Safety Authority
EFTAEuropean Free Trade Association
EHMAEuropean Health Management Association
EMAEuropean Medicines Agency
EPCEuropean Pharmacopoeia Commission
ESCPEuropean Society of Clinical Pharmacy
EUEuropean Union
FIPInternational Pharmaceutical Federation
GEONGeneral European OMCL Network
GMPgood manufacturing practice
HBchepatitis B core antigen
HBsAghepatitis B surface antigen
HCVhepatitis C virus
HIVhuman immunodeficiency virus
HMAHeads of Medicines Agencies
HMA-WGEOEU Heads of Medicines Agencies’ Working Group of Enforcement Officers
HTShigh-throughput sequencing (see also NGS)
HZJZHrvatski zavod za javno zdravstvo
Croatian Institute of Public Health
IgGimmunoglobulin
IPCIndian Pharmacopoeia Commission
IRinfrared
ISAInternational Standards for Antibiotics
ISBTInternational Society of Blood Transfusion
IVDRRegulation (EU) 2017/746 on in vitro diagnostic medical devices
JPJapanese Pharmacopoeia
LALlimulus amoebocyte lysate
LNALaboratory of Dutch Pharmacists (Farmaceutisch Laboratorium)
LNPlipid nanoparticle
mAbmonoclonal antibody
MATmonocyte-activation test
MDRRegulation (EU) 2017/745 on medical devices
MJAMutual Joint Audit
MJVMutual Joint Visit
mRNAmessenger ribonucleic acid
MRPMutual Recognition Procedure
MSSmarket surveillance study
NATnucleic amplification technique
NCAnational competent authority
NETTANetwork of National Focal Points on Travel for Transplantation
NFPnational focal point
NGSnext-generation sequencing (see also HTS)
NOMANorwegian Medical Products Agency
NPAnational pharmacopoeia authority
OCABROfficial Control Authority Batch Release
OCCLofficial cosmetics control laboratory
OMCLofficial medicines control laboratory
ONTOrganización Nacional de Trasplantes (Spanish National Transplant Organisation)
PaedF WPEuroepan Paediatric Formulary Working Party
PaedFormEuropean Paediatric Formulary
PDGPharmacopoeial Discussion Group
PDMPplasma-derived medicinal product
Ph. Eur.European Pharmacopoeia
PTSProficiency Testing Scheme
rFCrecombinant factor C
RITTARegistry of International Travel for Transplantation Activity
RPTrabbit pyrogen test
RTEMISReal-Time Remote Inspection System
SoHOsubstance of human origin
TFDATaiwan Food and Drug Administration
TNFtumour necrosis factor
TOCtotal organic carbon
TVtraining visit
USPUnited States Pharmacopeia
UVultraviolet
VBRNVeterinary Batch Release Network
WGworking group
WHOWorld Health Organization
WPworking party