Acronimi di interesse farmaceutico

TERM COUNTRY DEFINITION
AADA Int Abbreviated Antibiotic Drug Application
AAPS US American Association of Pharmaceutical Scientists
ABC US American Botanical Council
ABPI UK Association of British Pharmaceutical Industries
ACSI US American Customer Satisfaction Index
ADME Int Absorption, Distribution, Metabolism, and Excretion
ADR Int Adverse Drug Reaction
AF Int Application Form
AFI IT Associazione Farmaceutici Industria
AFSSPS FR Agence Francaise de Securite Sanitaire des Produits de Sante
AIC IT Autorizzazione Immissione in Commercio
AICQ IT Associazione Italiana per la Qualità
AICRC UK Association of Independent Clinical Research Contractors
AIFA IT Agenzia Italiana del Farmaco
AMG DE Arzneimittelgesetz (German Drug Law)
ANDA US Abbreviated New Drug Application
ANDS Int Abbreviated New Drug Submission
AO IT Azienda Ospedaliera
API Int Active Pharmaceutical Ingredients
ASL IT Azienda Sanitaria Locale
AR Int Assessment Report
ASMF Int Active Substance Master Files
BAPP UK British Association of Pharmaceutical Physicians
BfArM DE Bundesinstitut für Arzneimittel und Medizinprodukte (German: Federal Institute for Drugs and Medical Devices
BLA Int Biologics License Application
BP  UK British Pharmacopoeia
BPD Int Biocidal Products Directive
BPL IT Buona Pratica Laboratorio
BSE Int Bovine Spongiform Encephalopathy
CAPRA CND Canadian Association of Pharmaceutical Regulatory Affairs
CAT Int Committee for Advanced Therapies
CAS Number Int Chemical Abstracts Service Number
CBER US Center for Biologics Evaluation and Research
CDC US Centers for Disease Control
CDER US Center for Drug Evaluation and Research
CDRH US Center for Devices and Radiological Health
CE IT Consiglio Europeo
CEN Int Comité Européen de Normalisation
CEP Int Certificate European Pharmacopoeia
CES IT Comitato Economico e Sociale
CHMP Int Committee for Medicinal Products for Human Use
CIOMS Int Council for International Organizations of Medical Sciences
CIPE IT Comitato Interministeriale per la Programmazione Economica
CLP regulation Int Classification, Labelling and Packaging Regulation
CLV IT Certificato di Libera Vendita
CMC US Chemistry, Manufacturing, and Controls
CMD(h) Int Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
CMD(v) Int Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary
CMS Int Concerned Member State
CND IT Classificazione Nazionale dei Dispositivi Medici
COLIPA Int Comité de Liaison des Associations Européennes de LIndustrie de la Parfumerie, des Produits Cosmetiques et de Toilette
COMP Int Committee for Orphan Medicine Product
COPR Int Control of Pesticides Regulations
CoS Int Certificate of Suitability
CP Int Centralized Procedure
CPP IT Certificato di Prodotto Farmaceutico
CRC Int Clinical Research Coordinator
CRO Int Contract Research Organisation
CSD UK Committee on Safety of Medicines
CSR Int Clinical Study Report
CSS IT Consiglio Superiore di Sanità
CTD Int Common Technical Dossier
CTC UK Clinical Trial Certificate
CTS IT Commissione Tecnico Scientifica
CTX UK Clinical Trial Exemption
CUF IT Commissione Unica del Farmaco
CVMP Int Committee for Medicinal Products for Veterinary Use
DCP Int Decentralised Procedure
DD  Int Due Diligence
DDD Int Dear Doctor Letter
DDD Int Define Daily Dose/ Dose Define Die
DdL IT Disegno di Legge
DL IT Decreto Legge
D.Lgs. IT Decreto Legislativo
D.M. IT Decreto Ministeriale
DM IT Dispositivo Medico
DMF Int Drug Master File
DPI IT Dispositivi per la Protezione Individuale
DRG Int Diagnosis Related Groups
DDPS   Detailed Description Pharmacovigilance System
ECHA Int European Chemical Agency
ECM IT Educazione Continua in Medicina
eCTD Int electronic Common Technical Dossier
EDQM Int European Directorate for the Quality of Medicines & HealthCare 
EEA Int European Economic Area
EFPIA Int European Federation of the Pharmaceutical Industries and Associations
EFQM Int European Foundation for Quality Management
EFSA Int European Food Safety Authority
EFTA Int European Free Trade Association
EGA Int European Generic medicines Association
EINECS Int European Inventory of Existing Commercial Chemical Substances
EMA Int European Medicine Agency
EOQ Int European Organization for Quality
EPAR Int European Public Assessment Report
EPO Int European Patent Organisation
ESTRI Int Electronic Standards for the Transmission of Regulatory Information
ETOMEP Int European Technical Office for Medicinal Products
EUCOMED Int European Confederation of Medical Devices Association
EUDRA Int European Union Drug Regulatory Authorities
EVCTM Int EudraVigilance Clinical Trial Module 
EVDAS Int EudraVigilance Data warehouse Analysis System
FANS IT Farmaci Anti-infiammatori non Steroidei
FDA US Food and Drug Administration
FMEA Int Failure Mode and Effects Analysis
FSC Int Free Sale Certificate
FU IT Farmacopea Ufficiale
GCP Int Good Clinical Practice 
GDP Int Good Distribution Practice
GHS Int Globally Harmonised System
GHTS Int  Global Harmonisation Task Force
GLP Int Good Laboratory Practice 
GMDN Int Global Medical Device Nomenclature
GMP Int Good Manufacturing Practice 
GPvP Int Good Pharmacovigilance Practise
GVP Int Good Vigilance Practises
GU IT Gazzetta Ufficiale
HACCP Int Hazard Analysis Critical Control Point
HMA Int Heads of Medicines Agency
HMPC Int Committee on Herbal Medicinal Products
HPFB Int Health Products and Food Branch
HPLC Int High-performance liquid chromatography
HSE UK Healthy Survey for England
ICDRA Int International Conference of Drug Regulatory Authorities
ICH Int International Conference on Harmonisation 
ICSR Int Individual Case Safety Report
IDE US Investigational Device Exemption
IFPMA Int International Federation of Pharmaceutical Manufacturers & Associations
IfU Int Istruction for Use
INCI Int International Nomenclature of Cosmetic Ingredients
IND US Investigational New Drug Application
IRD Int Initial Receipt Dates
ISBN Int International Standard Book Number
ISO Int International Organization for Standardization
ISPRA IT Istituto Superiore per la Protezione e la Ricerca Ambientale
ISS IT Istituto Superiore di Sanità
ISTAT IT Istituto Nazionale di Statistica
IUCLID Int International Uniform Chemical Information Database
IUPAC Int International Union of Pure and Applied Chemistry
IVD Int In Vivo Diagnostic
JPMA Int Japan Pharmaceutical Manufacturers Association
LARN IT Livelli di Assunzione giornalieri Raccomandati di energia e Nutrienti
LoA Int Letter of Access
MA Int Marketing Authorization 
MAA Int Marketing Authorization Application
MAH Int Marketing Authorization Holder
MBTC Int Management Board Telematics Committee
MCA UK Medicines Control Agency
MD  Int Medical Device
MDMA US Medical Device Manufacturers Association
MdS - MinSal IT Ministero della Salute
MedDRA Int Medical Dictionary for Drug Regulatory Affairs
MHRA UK Medicines and Healthcare Products Regulatory Agency
MIUR IT Ministero dell'Istruzione, dell'Università e della Ricerca
MND SGP Ministry of National Development
MRP Int Mutual Recognition Procedure
NAS IT Nucleo Antisofisticazione e Sanità
NAS Int New Active Substance
NB   Int Notified Body
NBF IT Norme di Buona Fabbricazione
NCA UK National Competent Authority
NCI US National Cancer Institute
NCNPR Int National Center Natural Products Research
NDA US New Drug Application
NDS Int New Drug Submission
NIH Int National Institutes of Health
NOIS IT Nulla Osta Igienico Sanitario
NPA UK National Pharmaceutical Association
OD Int Orphan Drug
NSAID Int Nonsteroidal Anti-inflammatory Drug
OGD US Office of Generic Drugs
OGM IT Organismo Geneticamente Modificato
OMCL Int Official Medicines Control Laboratories
OMS IT Organizzazione Mondiale della Sanità
OTC Int Over the Counter
PAT Int Process Analytical Technology
PDCO Int Pediatric Committee
PHT IT Prontuario ospedale-territorio
PhVWP Int Pharmacovigilance Working Party
PICS FR Programmes Internationaux de Coopération Scientifique
PICS Int Pharmaceutical Inspection Cooperation Scheme
PIL Int Product Information Label
PIM  Int Product Information Management
PIP Int Pediatric Investigation Plan
PMA US Pre-market Authorization for approval of class III devices
PMC IT Presidio Medico Chirurgico
PMI IT Piccole e Medie Imprese
PRR Int Proportional Reporting Ratio
PRAC   Pharmacovigilance Risk Assessement Committee
PSMF Int Pharmacovigilance Sistem Master File
PSUR Int Product Safety Update Report
PVAR Int Preliminary Variation Assesment Report
RMS Int Reference Member State
QA Int Quality Assurance
QC Int Quality Control
QOS Int Quality Overall Summary
QP Int Qualified Person
QPPV Int Qualified Person Pharmacovigilance
QRD Int Quality Review of Documents 
RAEE IT Rifiuti di Apparecchiature Elettriche ed Elettroniche
RAPEX Int Rapid Exchange about Safety Product
RAPS Int Regulatory Affairs Professionals Society
RCP IT Riassunto delle Caratteristiche del Prodotto
RDA Int Recommended Daily Allowance
REACH Int Registration, Evaluation, Authorisation and Restriction of Chemicals
R&D Int Research and Development
RMP Int Risk Management Plan
RPSGB UK Royal Pharmaceutical Society of Great Britain
SAE Int Serious Adverse Event
SAG Int Scientific Advisory Group
SCI IT Società Chimica Italiana
SDRs Int Signals Disproportionate Reporting
SMF Int Site Master File
SME Int Small and Medium-sized Enterprise 
SOP US Standard Operating Procedure
SOP IT Senza Obbligo di Prescrizione
SIAF IT Sistema Informatico Anagrafe Fondi
SIAR IT Società Italiana Attività Regolatorie
SPC Int Summary of Product Characteristics
SSN IT Servizio Sanitario Nazionale
SUSAR Int Suspected, Unexpected, Serious Adverse Reaction
THR  Int Traditional Herbal Registration
THRMS Int Traditional Herbal Medicines Registration Scheme
TNG Int Technical Note for Guidance
ToC Int Table of Contents
TOPRA Int The Association for Regulatory Affairs Professionals
TRACS US Transit Rail Advisory Committee for Safety
TSE0 Int Transmissible Spongiform Encephalopathy
USAN US United States Adopted Names
USMAF IT Uffici Sanità Marittima Aerea e di Frontiera
USP US United States Pharmacopeia
USR Int Urgent Safety Restriction 
VAMF Int Vaccine Antigen Master File
WHO Int World Health Organisation