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ADE Adverse Drug Experience (US)
ADR Adverse Drug Reaction
AE Adverse Event (EU), Adverse Experience (US)
AR Assessment Report
ASMF Active Substance Master File
ASR Annual Safety Report
ATC-Code Anatomical Therapeutic Chemical-Code (WHO)
ATMP Advanced Therapy Medicinal Product
BE Bioequivalence
(C)CDS (Company) Core Data Sheet
CA Competent Authority
CAPA Corrective and Preventive Action
CBER Center for Biologics Evaluation and Research Committee for the evaluation of biologic products at the FDA
CCSI Company Core Safety Information
CDA Confidential Disclosure Agreement
CDER Center for Drug Evaluation and Research
CFR Code of Federal Regulations (US)
CHMP Committee for Medicinal Products for Human Use
CIOMS Council for International Organization of Medical Sciences
CMD(h) Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
CMS Concerned Member State
CTD Common Technical Document or Clinical Trial Document or Clinical Trials Directive (officially Directive 2001/20/EC)
CTDMB Clinical Trial Data Monitoring Board
DCP Decentralised Procedure
DCSI Development Core Safety Information
DLP Data Lock Point
DMC Data Monitoring Committee
DSMB Data Safety Monitoring Board
EBD European Birthdate
EC European Commission or Ethics Committee
eCTD electronic Common Technical Document
EEA European Economic Area
EEA European Economic Area
EMA European Medicines Agency
EPAR European Public Assessment Report
EU European Union
EudraCT European Clinical Trials Database
EV EudraVigilance
EVCT Eudravigilance Clinical Trial Module
EVMPD EudraVigilance Medicinal Product Dictionary
EVPM Eudravigilance Post-Authorisation Module
EVPRM EudraVigilance Product Report Message
FDA Food and Drug Administration (US)
FU(P) Follow up
GCP Good Clinical Practice
GL Guideline
GMP Good Manufacturing Practice
GVP Guideline on Good Pharmacovigilance Practices
HA Health Authority
HBD Harmonised Birth Date
HMA Heads of Medicines Agencies
HP Healthcare Professional
IB Investigator’s Brochure
IBD International Birthdate
IC Informed Consent
ICD Informed Consent Document or International Code of Diseases
ICF Informed Consent Form
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICH International Conference on Harmonization
ICSR Individual Case Safety Report
IDMB Independent Data Monitoring Board
IMP Investigational Medicinal Product
IND Investigational New Drug
IT Information Technology
LLT Low Level Term
LoQ List of Questions
M & S Marketing & Sales
MA Marketing Authorisation
MAA Marketing Authorisation Applicant
MAH Marketing Authorisation Holder
MedDRA Medical Dictionary for Regulatory Activities
MFR Manufacturer
MHRA Medicines and Healthcare products Regulatory Agency (UK)
MLM Medical Literature Monitoring
MP Medicinal Product
MRP Mutual Recognition Procedure
MS Member State
MSSO Maintenance and Support Services Organization (MedDRA)
N/A Not applicable
NCA National Competent Authority
NDA New Drug Approval or New Drug Application
NS Non-serious
NtA Notice to Applicants
OMP Orphan Medicinal Product
OTC Over-the-counter (non-prescription medicines)
PA(D)ER Periodic Adverse (Drug) Experience Report
PAES Post Authorisation Efficacy Study
PASS Post Authorisation Safety Study
PBRER Periodic Benefit-Risk Evaluation Report
PhV Pharmacovigilance
PI Package Insert or Product Information or Principle Investigator or Parallel Import
PIP Paediatric Investigation Plan
PK Pharmacokinetics
PL Package Leaflet
PQR Product Quality Review
PRAC Pharmacovigilance Risk Assessment Committee
PSMF Pharmacovigilance System Master File
PSUR Periodic Safety Update Report
PSUSA PSUR Single Assessment
PT Preferred Term
PUMA Paediatric Use Marketing Authorisation
PV Pharmacovigilance
PVA Pharmacovigilance Agreement
QA Quality Assurance
QA Quality Assurance
QC Quality Check
QC Quality Check or Quality Control
QM Quality Management
QP (GMP) Qualified Person (Good Manufacturing Practice)
QPPV Qualified Person responsible for Pharmacovigilance
QRD Quality Review of Documents
R & D Research & Development
RA Regulatory Affairs or Regulatory Authority
RAS Rapid Alert System
REG Regulation
RMP Risk Management Plan
RMS Reference Member State
RSI Reference Safety Information
SA Scientific Advice
SADR Serious Adverse Drug Reaction
SAE Serious Adverse Event
SC Study Coordinator
SD Source Data / Source Document or Single Dose or Standard Deviation
SDEA Safety Data Exchange Agreement
SDS Signal Detection Spreadsheet
SEQ Safety, Efficacy, Quality
SESAR Suspected Expected Serious Adverse Reaction
SME Significant Medical Event or Small and Medium Enterprises
SMF Site Master File
SmPC Summary of Product Characteristics
SMQ Standardised MedDRA Queries
SOP Standard Operating Procedure
SPC Supplementary Protection Certificate
SRC Safety Review Committee
SUSAR Suspected Unexpected Serious Adverse Reaction
TPM Third Party Manufacturer
VAERS Vaccine Adverse Event Reporting System
VeDDRA Veterinary Dictionary for Drug Related Affairs
VMP Veterinary Medicinal Product
WHO World Health Organisation
WP Working Procedure
XEVMPD eXtended Eudravigilance Medicinal Product Dictionary
XML Extensible Markup Language