Regulatory `jargon busters some key acronyms and abbreviations

510(K) ACP ADE ADEC ADR ADRAC AE AEM AFSSAPS AESGP AIDS AIM AMM ANDA ANDS AODM API APMA AR ASAP ATC AUC BA BAN BE BfArM BGTD BID BLA BMF Pre-market notification in US (devices) Associates of Clinical Pharmacology Adverse Drug Event/Adverse Drug Experience Australian Drug Evaluation Committee Adverse Drug Reaction Australian Drug Reactions Advisory Committee Adverse Event Agencia Espanola del Medicamento (Spanish Agency for Drugs) Agence Franaise de Securit Sanitaire des Produits de Sant Association Europenne des Societs Grands Publiques Acquired Immunodeficiency Syndrome Active Ingredient Manufacturer (EC) Autorisation Mise sur le March (French Marketing Authorisation) Abbreviated New Drug Application (US) Abbreviated New Drug Submission (Canada) Adult Onset Diabetes Mellitus Active Pharmaceutical Ingredient (FDA) Australian Pharmaceutical Manufacturers Association Assessment Report (EC) As Soon As Possible Anatomical Therapeutic Chemical Classification (WHO Code) Area under Curve Bioavailability British Approved Name Bioequivalence Bundesinstitut fr Arzneimittel und Medizinprodukte Biologics and Genetic Therapies Directorate (Canada) Two Times a Day Biologics Licence Application (US) Biologics Master File (US) BNF BP BPH BPM BRAS BT C&S CAGR CANDA CAP CAPLA CBC CBER CCRC CDC CDER CDRH CE CE CEN British National Formulary British Pharmacopoeia Benign Prostatic Hyperplasia/Hypertrophy Beats Per Minute Belgian Regulatory Affairs Society Biotechnology Culture & Sensitivity Cumulative Average Growth Rate Computer Aided New Drug Application (US) now ELA Color Additive Petition (US) Computer Assisted Product Licence Application (EC) Complete Blood Count Center for Biologics Evaluation & Research (FDA) Certified Clinical Research Coordinator Centers for Disease Control (US) Center for Drug Evaluation & Research (FDA) Center for Radiologic Health (US) Chemical Entity (Canada) Device marking in EU Comit Europen de Normalisation (European Committee for Standardisation) Code of Federal Regulations (US) Current Good Manufacturing Practice Council for International Organisations of Medical Science Chemistry, Manufacturing and Controls (US) Concerned Member State (EC) Central Nervous System Committee for Orphan Medicinal Products Clinical Operating Plan Dictionary used to code adverse experiences Central Pharmaceutical Affairs Council (Japan) Committee for Proprietary Medicinal Products (EC)

CFR cGMP CIOMS CMC CMS CNS COMP COP COSTART CPAC CPMP

CPS

CRA CRC CRF CRO CS CSA CSI CSM CSO CTC CTD CTD-E CTD-Q CTD-S CTE CTMP CTN CTX CUF CV CVMP CXR CY DAB DB DB DG DHHS/HHS DIA DIN DMF DNA DRG DRG DTD EC EC

Chemistry, Pharmacy and Standards Sub-Committee of the UK Committee on Safety of Medicines Clinical Research Associate Clinical Research Co-ordinator Case Report Form Contract Research Organisation Clinically Significant Clinical Support Associate Consulting Statisticians International Committee on Safety of Medicines (UK) Consumer Safety Officer Clinical Trial Certificate (UK) Common Technical Document Common Technical Document (Clinical Efficacy File) Common Technical Document (Quality File) Common Technical Document (Nonclinical Safety File) Clinical Trial Exemption (Australia) Clinical Trial on Marketed Product (UK) Clinical Trial Notification (EU and other countries) Clinical Trial eXemption (UK) Italian Drug Commission Curriculum Vitae Committee for Veterinary Medicinal Products (EC) Chest x-ray Calendar Year Deutsche Arzneibuch (German Pharmacopoeia) double-blind Dunn & Bradstreet (EC) Directorate General Department of Health & Human Services (US) Drug Information Association Drug Identification Number (Canada) Drug Master File Deoxyribonucleic Acid Data Review Guideline Diagnosis Related Group (used in hospitals, insurance term) Document Type Definition defines tags in an XML file European Community Ethics Committee

ECG ECJ e-CTD ECU EEA EEC EFPIA EFTA EGA EIR ELA EMEA EOF EOS EP EPAR ESRA ESTRI

ETT ETT EU EU Euro FAP FCI FD&C FDA FDA 1572 FDA 1639 FEDESA FOI FPL FR FTC FTIR

Electrocardiogram European Court of Justice Electronic Common Technical Document (ICH) European Currency Unit European Economic Area European Economic Community European Federation of Pharmaceutical Industry Associations European Free Trade Area European Generic Medicines Association Establishment Inspection Report (US) Electronic Licence Application (US) European Medicines Evaluation Agency National Drug Organisation (Greece) End of Study European Parliament European Public Assessment Report (EU) European Society for Regulatory Affairs Electronic Secure Transmission of Regulatory Information (ICH Working Group) Exercise Tolerance Test Endotrachael Tube European Union Evaluation Unit in the Therapeutic Goods Administration (Australia) European Currency (Euroland) Food Additive Petition (US) For Cause Inspection Federal Food, Drug & Cosmetic Act (US) Food and Drug Administration (US) Statement of Investigator Serious Adverse Event Reporting Form Fedration Europenne de la Sant Animale (Europe) Freedom of Information (US) Final Printed Labeling Federal Register Federal Trade Commission (US) Fourier Transform Infra Red

FU FUM FY GCP GdN

GGT GI GLC GLP GMO GMP GRAS GSL HCQIA HIV HPB HPLC HR HTN IC ICD 9 ICH IDDM IDE IM IMB IND INN IPRO IR IRB ISO ISBR ISE

Farmacopoeia Ufficiale (Italian Pharmacopoeia) Follow up Measure (EMEA) Fiscal Year Good Clinical Practices Guidizio de Notorietia (clinical trial notification sent to a registered Italian Ethics Committee) Gamma Glutamyl Transpeptidase Gastrointestinal Gas Liquid Chromatography Good Laboratory Practices Genetically Modified Organism Good Manufacturing Practices Generally Recognized As Safe (food additives in US) General Sales List (legal status for medicine in the UK) Health Care Quality Improvement Act Human Immunodeficiency Virus Health Protection Branch (Canada) High Pressure Liquid Chromatography Human Resources Hypertension Informed Consent International Classification of Diseases dictionary International Conference on Harmonisation Insulin Dependent Diabetes Mellitus Investigational Device Exemption (US) Intramuscular Irish Medicines Board Investigational New Drug Application (US) International Nonproprietary Name Independent Pharmaceutical Research Organisation Infra Red Institutional Review Board International Standards Organisation Integrated Summary of Benefit Risk (FDA) Integrated Summary of Efficacy (FDA)

ISS IV K+ KIKOU LD LKP LOA LOI MA MAA MAH MCA MCC MDL MEB MedDRA MHW MIMS MPA MPAR MR MRA MS MSC NA NAF NAI NAS NC NCE NCI NCS NDA NDS NEJM NF

Integrated Summary of Safety (FDA) Intravenous Potassium see OPSR (Japan) Lethal Dose Lnder Ethical Committee (Germany) Letter of Agreement Letter of Intent Marketing Authorisation (EC) Marketing Authorisation Application (EC) Marketing Authorisation Holder Medicines Control Agency (UK) Medicines Control Council (South Africa) Monitoring Deficiency List Medicines Evaluation Board (Netherlands) Medical Dictionary for Regulatory Activities (ICH) Ministry of Health & Welfare (Japan) Monthly Index of Medical Specialities (UK) Medicinal Products Agency (Sweden) Mutual Recognition Public Assessment Report (EC) Mutual Recognition (EC) Mutual Recognition Agreement (MRA) Member States (EC) Ministerio de Sanidad y Consumo (Spanish Ministry of Health) Not Applicable Notice of Adverse Findings (letter from FDA) No Action Indicated, FDA compliance code New Active Substance (EC) Notifiable Change (Canada) New Chemical Entity National Cancer Institute (US) Not Clinically Significant New Drug Application (US) New Drug Submission (Canada) New England Journal of Medicine National Formulary (US)

NHIS NIH NLM NLT NME NMR NMT NPAR NSAID NSR OE OHA OI OJ OPPR OPSR OTC P PAI PC PDF

PDR PEI PERF PEFRAS Ph. Eur Ph. Fr. PHS PI PLA PMA PMS PO

National Hygienic Sciences Institute (Japan) National Institutes of Health (US) National Library of Medicine (US) Not Less Than New Molecular Entity Nuclear Magnetic Resonance Not More Than National Public Assessment Report Nonsteroidal AntiInflammatory Drug Nonsignificant Risk Oral Explanation (EMEA) Office of Health Affairs (FDA) Outstanding Issues (EMEA) Official Journal of the European Communities Office for Protection from Research Risks (US) Office for Pharmaceutical and Safety Research (KIKOU) (Japan) Over the Counter Pharmacy Sale (legal status for medicine in the UK) Pre-Approval Inspection Personal Computer Portable Document Format Adobe proprietary standard for electronic transfer of documents Physician's Desk Reference (US) Paul Ehrlich Institut (Germany) Pan-European Regulatory Forum Pan-European Federation of Regulatory Affairs Societies Pharmacope Europen (European Pharmacopoeia) Pharmacope Franaise (French Pharmacopoeia) Public Health Service (US) Principal Investigator Product License Application in US (for biologics) Pre-Market Approval (for devices, sometimes PMAA) Post-Marketing Surveillance Per Os (by mouth)

POM PR PR PRN PTC QA QC QD QID QNS R&D RAPID RAPS RDE rDNA RMS RNA SAE SANDS SAS SAS SBA SCOTT SD SGML

SGOT/(AST) SGPT/(ALT) SIAR SLK SNDA SNDS

Prescription Only Medicine (legal status for medicine in UK) Pulse Rate Public Relations As Needed Points to consider (FDA) Quality Assurance Quality Control Once Daily Four Times a Day Quantity Not Sufficient Research and Development Rapid Access Physician Investigator Data Base Regulatory Affairs Professional Society Remote Data Entry recombinant DNA Reference Member State (EC) Ribonucleic Acid Serious Adverse Event Supplemental Abbreviated New Drug Submission (Canada) Special Access Scheme (named patient usage in Australia) Statistical Analysis Software (commercial software from SAS Corporation) Summary Basis of Approval (drugs, US) Standing Committee on Therapeutic Trials (New Zealand) Source Document Standard Generalised Markup Language (a metalanguage to construct other markup languages) Serum Glutamic Oxalacetic Transaminase/Aspartate Transaminase Serum Glutamic Pyruvic Transaminase/Alanine Transaminase Societa Italiana Attiva Regolatore Norwegian Medicines Control Agency Supplemental NDA (US) Supplemental New Drug Submission (Canada)

SNIP

SO SOP SPC (SmPC) SPC SC SSE TGA TID TLC

Syndicat National de lIndustrie Pharmaceutique (French pharma industry association) Specific Obligations (EMEA) Standard Operating Procedure Summary of Product Characteristics (EC) Supplementary Patent Certificate (EC) Subcutaneous Summary of Safety and Effectiveness (devices) Therapeutic Goods Administration (Australia) Three Times a Day Thin Layer Chromatography

TPD TSH UA UK URI USA USAN USP UTI VAR VICH WHO WNL XML

Therapeutic Products Directorate (Canada) Thyroid Stimulating Hormone Urinalysis United Kingdom Upper Respiratory Infection United States of America United States Approved Name U.S. Pharmacopeia Urinary Tract Infection Variation Assessment Report (EC) Veterinary International Conference on Harmonisation World Health Organisation Within Normal Limits eXtensible Markup Language a dialect of SGML