| 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 |
