Abbreviations and Acronyms - pharmacovigilance-material

Abbreviations and Acronyms

A list of abbreviations and acronyms found in the field of, or connected with, pharmacovigilance.

ACSoMP       Advisory Committee on Safety of Medicinal Products (WHO)

ACT              Artemisinin-based combination therapy

ADE             Adverse drug event/effect

ADR             Adverse drug reaction

AEFI            Adverse event following immunisation

AEMPS        Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines

                                 andHealthcare Products Agency)

AFSSAPS     Agence française de sécurité sanitaire des produits de santé, France

API              Active pharmaceutical ingredient (WHO)

ART             Antiretroviral therapy

ARV             Antiretrovirals

ATC              Anatomical, Therapeutic, Chemical classification

BCPNN        Bayesian Confidence Propagation Neural Network

BfArM          Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs

                                    and Medical Devices in Germany)

BMA             British Medical Association

CDC              Centers for Disease Control and Prevention

CEM              Cohort Event Monitoring

CEN               Centre Européen de Normalisation (the European Committee for Standardization)

CHMP           Committee on Medicinal Products for Human use (EU), previously CPMP

CIOMS          Council for International Organizations of Medical Sciences

CRO              Contract research organisation (often responsible for clinical trials)

DDD                       Defined Daily Dose

DIA	Drug Information Association
DSRU	Drug Safety Research Unit, Southampton, UK
DTC	Direct to consumer
DTP	Direct to patient
EEA	European Economic Area
EMA	European Medicines Agency
EU	European Union
E2B	The current international standard for ADR reporting developed by ICH
FDA	Food and Drug Administration (USA regulatory body)
FIC	(WHO) Family of International Classifications
FIP	International Pharmaceutical Federation
	1/4	Prepared by the Uppsala Monitoring Centre, March 2011

FOI	Freedom of information
FTP	File transfer protocol
GACVS	Global Advisory Committee on Vaccine Safety (WHO)
GCP	Good clinical practice. For example:
	www.who.int/medicines/library/par/ggcp/GGCP0.shtml
GF	Gates Foundation (full name Bill and Melinda Gates Foundation) or Global Fund (see
	also GFTAM)
GFTAM	Global Fund to Fight AIDS, Tuberculosis and Malaria
GLP	Good laboratory practice For example:
	www.oecd.org/department/0,2688,en_2649_34381_1_1_1_1_1,00.html
GMP	Good manufacturing practice For example:
	www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/orggmp.shtml
GxP	generic term for good practice requirements in the pharmaceutical industry
HAI	Health Action International www.haiweb.org
HATC	Herbal ATC
HSA	Health Sciences Authority, Singapore
IC	Information Component (used in BCPNN) – Informed consent
ICD	International Classification of Diseases
ICDRA	International Conference for Drug Regulatory Authorities
ICH	International Conference on Harmonisation of Technical Requirements for
	Registration of Pharmaceuticals for Human Use
ICSR	Individual case safety report
IMB	Irish Medicines Board
IMMP	The Intensive Medicines Monitoring Programme, New Zealand
IMS	Not an acronym. Company providing statistics and information in the health
	care sector
INN	International non-proprietary names (for pharmaceutical substances)
IPCS	International Programme on Chemical Safety www.who.int/pcs
ISO	International Organization for Standardization www.iso.org
ISoP	International Society of Pharmacovigilance www.isoponline.org
ISPE	International Society for Pharmacoepidemiology www.pharmacoepi.org
JPMA
	Japan Pharmaceutical Manufacturer’s Association
Lareb	Netherlands Pharmacovigilance Foundation (Landelijke Registratie en Evaluatie van
	Bijwerkingen)
MAH	Market authorisation holder
MedDRA	Medical Dictionary for Drug Regulatory Affairs
MHRA	Medicines and Healthcare products Regulatory Agency (UK)
MSSO	Maintenance and Support Services Organization (for MedDRA)
MSF	Médecins Sans Frontières
NC	National centre (for pharmacovigilance)
	2/4	Prepared by the Uppsala Monitoring Centre, March 2011

NCE	New chemical entity
NDA	New Drug Application
NGO	Non-governmental organisation
NME	New molecular entity
NSAID	Non-steroidal anti-inflammatory drug
OTC	Over-the-counter
PCC	Poison Control Centre
PDR	Physician’s Desk Reference
PDS	Pharmacoepidemiology and Drug Safety (journal)
PEM	Prescription event monitoring
PEPFAR	US President’s Emergency Plan for AIDS Relief
PHRMA	Pharmaceutical Research and Manufacturers Association
PIL	Package insert leaflet
PMDA	Pharmaceuticals and Medical Devices Agency, Japan
PMS	Post-marketing surveillance
POM	Prescription only medicine
PPI	Proton Pump Inhibitor
PSM	Procurement and supply management
PSUR	Periodic safety update report
PV	Pharmacovigilance
QA	Quality Assurance
QSM-WHO	Quality Assurance and Safety of Medicines (WHO)
RCA	Root-cause analysis
SFDA	State Food and Drug Administration, China
SMQ	Standardized MedDRA Query
SOC	System organ class
SOP	Standard operating procedure
SPC	Summary of product characteristics (in the EU)
SSRI	Selective Serotonin Reuptake Inhibitor (group of anti-depressants)
TGA	Therapeutic Goods Administration, Australia
UMC	the Uppsala Monitoring Centre www.who-umc.org
UNITAID	Not an acronym. Organization cooperating with WHO and others on the WHO
	millennium goals
VAERS	Vaccine adverse event reporting system
WAHO	West African Health Organization
WHO	World Health Organization www.who.int
WHO-ART	WHO Adverse Reaction Terminology
WHO-CC	WHO Collaborating Centre
	3/4	Prepared by the Uppsala Monitoring Centre, March 2011

WHO-DD       WHO Drug Dictionary

WHO-DDE WHO Drug Dictionary Enhanced

XML                   Extensible Mark-up Language

4/4                       Prepared by the Uppsala Monitoring Centre, March 2011