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 |
AUA | IT | Autorizzazione Utenze Aziendali |
API | Int | Active Pharmaceutical Ingredients |
ASL | IT | Azienda Sanitaria Locale |
AR | Int | Assessment Report |
ASMF | Int | Active Substance Master Files |
BAID | Int | Medicinal Product Batch Identifier |
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 |
CAPA | Int | Corrective And Preventive Action |
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 |
CGMPs | Int | Current Good Manufacturing Practices |
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 |
CTA | Int | Clinical Trial Application |
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 |
EMVO | Int | European Medicines Verification Organisatio |
EMVS | | European Medicines Verification System |
EOQ | Int | European Organization for Quality |
EPAR | Int | European Public Assessment Report |
EPO | Int | European Patent Organisation |
ESOP | Int | Electronic Standard Operating Procedure |
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 |
EUNDB | | European Union Network Data Board |
EVCTM | Int | EudraVigilance Clinical Trial Module |
EVDAS | Int | EudraVigilance Data warehouse Analysis System |
EVI | | European Medicines Verification System Information |
FANS | IT | Farmaci Anti-infiammatori non Steroidei |
FDA | US | Food and Drug Administration |
FMD | | Falsified Medicines Directive |
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 |
GTIN | | Global Trade Identification Number |
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 |
IDMP | | Identification of Medicinal Products |
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 |
MDR | Int | Medical Devices Regulations |
MdS – MinSal | IT | Ministero della Salute |
MEA | Int | Managed Entry Agreements |
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 |
MPID | | Medicinal Product Identifier |
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 |
NMVO | | National Medicines Verification Organisations |
NOIS | IT | Nulla Osta Igienico Sanitario |
NPA | UK | National Pharmaceutical Association |
OBP | | On-Boarding Partner |
OD | Int | Orphan Drug |
ON | IT | Organismi Notificati |
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 |
PCID | | Packaged Medicinal Product Identifier |
PDCO | Int | Pediatric Committee |
PhPID | | Pharmaceutical Product Identifier |
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 |
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 |
SPOR | | Substance, Product, Organisations and Referentials |
SSN | IT | Servizio Sanitario Nazionale |
SUSAR | Int | Suspected, Unexpected, Serious Adverse Reaction |
SVHC | Int | Substances of Very High Concern |
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 |
VNR | IT | Valori Nutritivi di Riferimenti |
WHO | Int | World Health Organisation |