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

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