Dec 16, 2018

Pharmacovigilance Abbreviations / Acronyms


Term Description
ADCO Addendum to Clinical Overview
ADRs Adverse Drug Reactions
AE Adverse Event
AERS Adverse Event Reporting System
ANDA Abbreviated New Drug Application
ATC Anatomical Therapeutic Chemical  (in Anatomical Therapeutic 
Chemical
Classification System)
ATMP Advanced Therapy Medicinal Product
CAPA Corrective And Preventive Action
CCDS Company Core Data Sheet
CCSI Company Core Safety Information
CHMP Committee for Medicinal Products for Human Use
CIOMS Council for International Organizations of Medical Sciences
CMDh Coordination Group for Mutual Recognition and Decentralised
 Procedures - Human
CMS Concerned Member State
CRO Contract Research Organization
CT Clinical Trial
CTD Common Technical Document
DCP Decentralised Procedure
DDD Defined Daily Dose
DHPC Direct healthcare professional communication
DIBD Development international birth date
DLP Data Lock Point
DME Designated Medical Event
DSUR Development safety update report
DUS Drug Utilization Study
EMA European Medicine Agency
EU European Union
EURD European Union Reference Date
EV Eudravigilance
FDA Food and Drug Administration
GCP Good Clinical Practice
GMP Good Manufacturing Practice
GVP Good Pharmacovigilance Practice
IB Investigator´s Brochure
IBD International birth date
ICH  International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
ICSRs Individual Case Safety Reports
IME Important Medical Event
IND Investigational New Drug
INN International Non-proprietary Name
LBI Late Breaking Information
MA Marketing Authorisation
MAH Marketing Authorisation Holder
MedDRA Medical Dictionary for Regulatory Activities
MHRA Medicines and Healthcare Products Regulatory Agency
MRP Mutual Recognition Procedure
NAP National Authorised Product
NCA National Competent Authority
NDA New Drug Application
PASS Post-authorisation safety study
PBRER Periodic Benefit-Risk Evaluation Report
PI Product Information
PIL Product Information Leaflet
PL Package Leaflet
PRAC Pharmacovigilance Risk Assessment Committee
PSMF Pharmacovigilance system master file
PSUR Periodic Safety Update Report
PSUSA Periodic Safety Update Single Assessment
PT Preferred Term
PTD Patient Treatment Days
PTY Patient Treatment Years
PV Pharmacovigilance
QPPV Qulified Person responsible for Pharmacovigilance
REMS Risk Evaluation & Mitigation Strategies
RMM Risk Minimisation Measure
RMP Risk Management Plan
RMS Reference Member State
RSI Referenced Safety Information
SAE Serious Adverse Event
SAR Serious Adverse Reaction
SDEA Safety Data Exchange Agreement
SmPC Summary of Product Characteristics
SMQ Standardized MedDRA Query
SOC System Organ Class
SOP Standard Operating Procedure
TSSS Tabular Summary of Safety Signals
WHO World Health Organization 
XEVIMPD Extended EudraVigilance Investigational Medicinal Product Dictionary
XEVPRM eXtended EudraVvigilance Product Report Message