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A
ADEAdverse Drug Experience (US)
ADRAdverse Drug Reaction
AEAdverse Event (EU), Adverse Experience (US)
ARAssessment Report
ASMFActive Substance Master File
ASRAnnual Safety Report
ATC-CodeAnatomical Therapeutic Chemical-Code (WHO)
ATMPAdvanced Therapy Medicinal Product
B
BEBioequivalence
C
(C)CDS(Company) Core Data Sheet
CACompetent Authority
CAPACorrective and Preventive Action
CBERCenter for Biologics Evaluation and Research Committee for the evaluation of biologic products at the FDA
CCSICompany Core Safety Information
CDAConfidential Disclosure Agreement
CDERCenter for Drug Evaluation and Research
CFRCode of Federal Regulations (US)
CHMPCommittee for Medicinal Products for Human Use
CIOMSCouncil for International Organization of Medical Sciences
CMD(h)Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
CMSConcerned Member State
CTDCommon Technical Document or Clinical Trial Document or Clinical Trials Directive (officially Directive 2001/20/EC)
CTDMBClinical Trial Data Monitoring Board
D
DCPDecentralised Procedure
DCSIDevelopment Core Safety Information
DLPData Lock Point
DMCData Monitoring Committee
DSMBData Safety Monitoring Board
E
EBDEuropean Birthdate
ECEuropean Commission or Ethics Committee
E
eCTDelectronic Common Technical Document
E
EEAEuropean Economic Area
EEAEuropean Economic Area
EMAEuropean Medicines Agency
EPAREuropean Public Assessment Report
EUEuropean Union
EudraCTEuropean Clinical Trials Database
EVEudraVigilance
EVCTEudravigilance Clinical Trial Module
EVMPDEudraVigilance Medicinal Product Dictionary
EVPMEudravigilance Post-Authorisation Module
EVPRMEudraVigilance Product Report Message
F
FDAFood and Drug Administration (US)
FU(P)Follow up
G
GCPGood Clinical Practice
GLGuideline
GMPGood Manufacturing Practice
GVPGuideline on Good Pharmacovigilance Practices
H
HAHealth Authority
HBDHarmonised Birth Date
HMAHeads of Medicines Agencies
HPHealthcare Professional
I
IBInvestigator’s Brochure
IBDInternational Birthdate
ICInformed Consent
ICDInformed Consent Document or International Code of Diseases
ICFInformed Consent Form
ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICHInternational Conference on Harmonization
ICSRIndividual Case Safety Report
IDMBIndependent Data Monitoring Board
IMPInvestigational Medicinal Product
INDInvestigational New Drug
ITInformation Technology
L
LLTLow Level Term
LoQList of Questions
M
M & SMarketing & Sales
MAMarketing Authorisation
MAAMarketing Authorisation Applicant
MAHMarketing Authorisation Holder
MedDRAMedical Dictionary for Regulatory Activities
MFRManufacturer
MHRAMedicines and Healthcare products Regulatory Agency (UK)
MLMMedical Literature Monitoring
MPMedicinal Product
MRPMutual Recognition Procedure
MSMember State
MSSOMaintenance and Support Services Organization (MedDRA)
N
N/ANot applicable
NCANational Competent Authority
NDANew Drug Approval or New Drug Application
NSNon-serious
NtANotice to Applicants
O
OMPOrphan Medicinal Product
OTCOver-the-counter (non-prescription medicines)
P
PA(D)ERPeriodic Adverse (Drug) Experience Report
PAESPost Authorisation Efficacy Study
PASSPost Authorisation Safety Study
PBRERPeriodic Benefit-Risk Evaluation Report
PhVPharmacovigilance
PIPackage Insert or Product Information or Principle Investigator or Parallel Import
PIPPaediatric Investigation Plan
PKPharmacokinetics
PLPackage Leaflet
PQRProduct Quality Review
PRACPharmacovigilance Risk Assessment Committee
PSMFPharmacovigilance System Master File
PSURPeriodic Safety Update Report
PSUSAPSUR Single Assessment
PTPreferred Term
PUMAPaediatric Use Marketing Authorisation
PVPharmacovigilance
PVAPharmacovigilance Agreement
Q
QAQuality Assurance
QAQuality Assurance
QCQuality Check
QCQuality Check or Quality Control
QMQuality Management
QP (GMP)Qualified Person (Good Manufacturing Practice)
QPPVQualified Person responsible for Pharmacovigilance
QRDQuality Review of Documents
R
R & DResearch & Development
RARegulatory Affairs or Regulatory Authority
RASRapid Alert System
REGRegulation
RMPRisk Management Plan
RMSReference Member State
RSIReference Safety Information
S
SAScientific Advice
SADRSerious Adverse Drug Reaction
SAESerious Adverse Event
SCStudy Coordinator
SDSource Data / Source Document or Single Dose or Standard Deviation
SDEASafety Data Exchange Agreement
SDSSignal Detection Spreadsheet
SEQSafety, Efficacy, Quality
SESARSuspected Expected Serious Adverse Reaction
SMESignificant Medical Event or Small and Medium Enterprises
SMFSite Master File
SmPCSummary of Product Characteristics
SMQStandardised MedDRA Queries
SOPStandard Operating Procedure
SPCSupplementary Protection Certificate
SRCSafety Review Committee
SUSARSuspected Unexpected Serious Adverse Reaction
T
TPMThird Party Manufacturer
V
VAERSVaccine Adverse Event Reporting System
VeDDRAVeterinary Dictionary for Drug Related Affairs
VMPVeterinary Medicinal Product
W
WHOWorld Health Organisation
WPWorking Procedure
X
XEVMPDeXtended Eudravigilance Medicinal Product Dictionary
XMLExtensible Markup Language