Table of abbreviations

TERMDESCRIPTION
3R principlesreplacement reduction and refinement (animal testing)
AAVadeno-associated virus
AESANAgencia Española de Seguridad Alimentaria y Nutrición
AnvisaAgência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency)
ATMPadvanced therapy medicinal product
BEblood establishment
BoMRABotswana Medicines Regulatory Authority
BRPbiological reference preparation
BSPBiological Standardisation Programme
BTCblood, tissues and cells
BWPBiologics Working Party
CAcompetent authority
CAPcentrally authorised product
CAS numberChemical Abstracts Service Registry number
CATCommittee for Advanced Therapies
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 Organ Transplantation
CD-P-TSEuropean Committee on Blood Transfusion
CEPCertificate of Suitability to the European Pharmacopoeia monographs
CETSCouncil of Europe Treaty Series
CIPCoalition of Interested Parties
CoPCommittee of the Parties
CPPSCentre for Pharmaceutical Products Safety
CRSchemical reference substance
CVUAChemisches und Veterinäruntersuchungsamt Karlsruhe (Chemical and Veterinary Investigation Office, Karlsruhe)
DCDdonation after circulatory death
DCPdecentralised procedure
EAEuropean Co-operation for Accreditation
EAHPEuropean Association of Hospital Pharmacists
ECBSExpert Committee on Biological Standardization
ECDCEuropean Centre for Disease Prevention and Control
ECSPPExpert Committee on Specifications for Pharmaceutical Preparations (WHO)
EDDEuropean Donation Day
EDQMEuropean Directorate for the Quality of Medicines & HealthCare
EEAEuropean Economic Area
EFSAEuropean Food Safety Authority
EFTAEuropean Free Trade Association
ELISAenzyme-linked immunosorbent assay
EMAEuropean Medicines Agency
EPCEuropean Pharmacopoeia Commission
EQAASExternal Quality Assurance Assessment Scheme
ESCPEuropean Society of Clinical Pharmacy
ESOPEuropean Society of Oncology Pharmacy
EUEuropean Union
FIPInternational Pharmaceutical Federation
GEONGeneral European OMCL Network
GMPgood manufacturing practice
GNPGlobal Network of NQCLs for Pharmaceuticals (WHO)
GSGGlobal Steering Group
GSMSGlobal Surveillance and Monitoring System for substandard and falsified medical products (WHO database)
GTMPgene therapy medicinal product
GTWGGene Therapy Products Working Group
HMAHeads of Medicines Agencies
HMA-WGEOEU Heads of Medicines Agencies’ Working Group of Enforcement Officers
HOPEEuropean Hospital and Healthcare Federation
ICHInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICRSInternational Chemical Reference Substance
IgGimmunoglobulin
IPCIndian Pharmacopoeia Commission
IPRPInternational Pharmaceutical Regulators Program
IRinfrared
ISAInternational Standards for Antibiotics
ISBTInternational Society of Blood Transfusion
ISOInternational Organization for Standardization
ISO/TCISO technical committee
IVMPimmunological veterinary medicinal product
IWPImmunologicals Working Party
JPJapanese Pharmacopoeia
LALlimulus amoebocyte lysate
LC-MS/MSliquid chromatography with tandem mass spectrometry
LMMlow-molecular mass
MA marketing authorisation
MATmonocyte-activation test
MEPmember of the European Parliament
MJAMutual Joint Audit
MJVMutual Joint Visit
MRPMutual Recognition Procedure
MSSmarket surveillance study
MSSFPmarket surveillance fingerprint study
MSSIPmarket surveillance study on suspected illegal products
MTSMedium-Term Strategy
NATnucleic amplification technique
NCAnational competent authority
NETTANetwork of National Focal Points on Travel for Transplantation
NFPnational focal point
NIFDCnational institute for food and drug control
NNBNCL Network for Biologicals
NPAnational pharmacopoeia authority
NCQLnational quality control laboratory
OBPROfficial Batch Protocol Review
OCABROfficial Control Authority Batch Release
OCCLofficial cosmetics control laboratory
OMCLofficial medicines control laboratory
ONTOrganización Nacional de Trasplantes (Spanish National Transplant Organisation)
PaedFEuroepan Paediatric Formulary Working Party
PaedFormEuropean Paediatric Formulary
PDCOPaediatric Committee (EMA)
PDGPharmacopoeial Discussion Group
PDMPplasma-derived medicinal product
PGEUPharmaceutical Group of the European Union
Ph. Eur.European Pharmacopoeia
PM RAPost-marketing risk assessment
PTSProficiency Testing Scheme
QMquality management
QMSquality management system
QWPQuality Working Party
RITTARegistry of International Travel for Transplantation Activity
RPTrabbit pyrogen test
RSreference standard
RSVrespiratory syncytial virus
RTEMISReal-Time Remote Inspection System
SAREsevere adverse reactions and events
SoHOsubstance of human origin
SOPstandard operating procedure
SUPsuspicious unknown product
TBEtick-borne encephalitis
TFDATaiwan Food and Drug Administration
TSEtransmissible spongiform encephalopathy
TVtraining visit
USPUnited States Pharmacopeia
VBRNVeterinary Batch Release Network
WGworking group
WHAWorld Health Assembly
WHOWorld Health Organization
WOAHWorld Organisation for Animal Health
WPworking party