Acronyms
|
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 |
|
USP |
US |
United States Pharmacopeia |
|
USR |
Int |
Urgent Safety Restriction |
|
VAMF |
Int |
Vaccine Antigen Master File |
|
WHO |
Int |
World Health Organisation |