| TERM |
COUNTRY |
DEFINITION |
| AADA |
Int |
Abbreviated Antibiotic Drug Application |
| AAPS |
US |
American Association of Pharmaceutical Scientists |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Acronyms
