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Sunday, 28 June 2020 Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations Pharmaceutical Regulatory Affairs - Glossary of acronyms and abbreviations A AADA Abbreviated antibiotic drug application ABHI Association of British Healthcare Industries ABPI Association of the British Pharmaceutical Industry ACTD ASEAN common technical dossier ADC Additional Data Collection ADI Acceptable daily Intake ADR Adverse drug reaction AE Adverse event AEFI Adverse event following immunization AEMPS Agencia Española de Medicamentos y Productos Sanitarios (Spanish Medicines and Healthcare Products Agency) AGES Austrian Agency for Health and Food Safety AIFA Agenzia Italiana del Farmaco (Italian Medicines Agency) AIM Active ingredient manufacturer AIMD Active implantable medical device ANDA Abbreviated new drug application ANSM Agence nationale de sécurité du médicament et des produits de santé (French Medicines Agency) API Active pharmaceutical ingredient AQL Acceptable quality level AR Assessment Report (European Union) ASMF Active Substance Master File ASR Annual safety report ATMPs Advanced therapy medicinal products ATC Anatomical Therapeutic Chemical B BA Bioavailability BAN British Approved Name BAP Biotechnology Action Programme BfArM Bundesinstitut für Arzneimittel und Medisinprodukte (Federal Institute for Drugs and Medical Devices in Germany) BIND Biological investigational new drug BNF British National Formulary BOS Break-out session (happens during a DCP/MRP/CP) BP British Pharmacopoeia BWP Biotech Working Party (EMA) C C&P Chemistry and Pharmacy CA Commercial appraisal CA Competent authority (a medicines regulatory authority in the European Union) CANDA Computer assisted new drug application CAP Centrally authorised product CAPA Corrective action and preventive action CAPLA Computer Assisted Product Licence Application CC Candidate country CCDS Company core data sheet CCG Clinical Commissioning Group (UK) CD Controlled drug CDSCO Central Drugs Standard Control Organisation CEP Certification of suitability to the Monographs of the European Pharmacopoeia CHMP Committee for Medicinal Products for Human Use cGLP Current good laboratory practice cGMP Current good manufacturing practice Cl Total body clearance CIOMS Council for International Organisations of Medical Sciences CLO Clinical overview CLS Clinical summary CMC Chemistry- manufacturing- controls CMDh Co-ordination group for Mutual recognition and Decentralised procedures – Human CMDv Co-ordination group for Mutual recognition and Decentralised procedures – Veterinary CMP Certificate of Medicinal Product CMS Concerned Member State (European Union) CO clinical overview COA Certificate of analysis CoFS Certificate of Free Sale COMP Committee on Orphan Medicinal Products CP Centralised procedure (European Union) CP Comparability protocol (USA) CPD Continuing professional development CPP Certificate of pharmaceutical product CPP Critical process parameter CQA Clinical quality assurance CR Controlled release CRF Case report form CRO Clinical Research Organisation CRO Contract research organisation CSI Core safety information CSP Core safety profile CSR Clinical study report (European Union) CT Clinical trial CTA Clinical trial application CTA Clinical trial authorisation CTC Clinical trial certificate (UK) CTD Clinical Trials Directive CTD Common technical document/dossier CTMS Clinical trial management system CTS Common technical specification CTX Clinical trial exemption (UK) CVM Center for Veterinary Medicine (US) D DACS Detailed and critical summary DAE Discontinuation due to an adverse event DCP Decentralised procedure DDD Defined daily dose DDPS Detailed description of pharmacovigilance system DMF Drug master file DMS Document management system DOE Design of experiments DP Drug product DS Drug substance DSUR Development safety update report DTC Direct-to-consumer DUS Drug utilisation study E EA Environmental assessment EC Ethics committee eCTD Electronic common technical document EDC Electronic data capture EDQM European Directorate for the Quality of Medicines & Healthcare EDMF European drug master file EDT Electronic data transfer EEA European economic area EMA European Medicines Agency ENS Early notification system EP European Pharmacopeia EPI Essential Program for Immunisation EPL Effective patent life ePSUR Eelectronic periodic safety update report ERA Environmental risk assessment ERB Ethical review board ESPAR Executive Summary Pharmacovigilance Assessment Report EWG Expert Working Group EWP Efficacy Working Party F FAMHP Federal Agency for Medicines and Health Products (of Belgium) FAR Final assessment report FAR Field Alert Report FDA Food and Drug Administration FMEA Failure mode and effects analysis FIMEA Finnish Medicines Agency FTE Full Time Equivalent G GCP Good clinical practice GDP Good distribution practice GGP Good guidance practice GLP Good laboratory practice GMO Genetically modified organism GMP Good manufacturing practice GMP Good management practice GPP Good paediatric practice GPP Good pharmacoepidemiology practice GpvP Good pharmacovigilance practice GRB Global Regulatory Board GRP Good regulatory practice GSL General sales list GSP Good statistics practice GVP Good pharmacovigilance practice H HCP Healthcare professional HEOR Health economics and outcomes research HMA Heads of Medicines Agencies (EU) HPRA Health Product Regulatory Authority HREC Human Research Ethics Committee HTA Health technology assessment HTS High-throughput screening I IB Investigator’s brochure IC Informed consent ICH International Council on Harmonisation ICD Informed consent document ICSR Individual case safety report IDE Investigational Device Exemption IDMP Identification of medicinal products IEC Independent ethics committee IM Issue management IMA Icelandic Medicines Agency IMI Innovative Medicines Initiative IMP Investigational medicinal product IMPD Investigational medicinal product dossier IMRDF International Medical Device Regulatory Forum IMS Information management strategy INN International non –proprietary names INDA Investigational new drug application (USA) INDC Investigational New Drug Committee IP Intellectual property IPO Intellectual Property Office IPR Intellectual property rights IQM Integrated quality management IRB Institutional review board IRD International registration document IRN Incident Review Network IS Internal standard ISE Integrated summary of efficacy ISRB Integrated summary of risk benefit ISS Integrated summary of safety K KIT Key intelligence topic KM Knowledge management KOL Key opinion leader L LCM Lifecycle management LED Least Effect Dose LLL Lifelong learning LOA letter of authorisation M MA Marketing authorisation MAA Marketing authorisation application (EU) MAH Marketing authorisation holder MAIL Medicines act information letter (UK) MAL Medicines Act Leaflet (UK) MAT Marketing authorisation transfer MDCG Medical Device Coordination Group MDD Medical Device Directive MDEG Medical Device Expert Group MDLO Medical Device Liaison Officer MDR Medical device reporting MedDRA Medical Dictionary for Regulatory Activities MERS Multi-agency electronic regulatory system MHRA Medicines and Healthcare products Regulatory Agency (UK) ML Manufacturer’s licence (UK) MOU Memorandum of Understanding MRA Mutual recognition agreement MRP Mutual recognition procedure MS Member state(EU) N NAP Nationally authorised product NBE New biological entity NCA National Competent Authority NCE New chemical entity NCO Non clinical overview NCS Non clinical summary NDAC New Drug Advisory Committee (India) NED Non effect dose NIMP Non-investigational medicinal product NME New molecular entity NOMA The Norwegian Medicines Agency O OD Orphan drug ODA Orphan Drugs Act (USA) ODD Orphan drug designation OIA Official action indicated OOS Out of specification OPD Original pack dispensing OTC Over-the-counter P P&R Pricing and reimbursement P Pharmacy only P to GSL Pharmacy to General Sales List PA Product authorization PAI Pre-approval inspection PAR Preliminary assessment report PASS Post authorisation safety study PAT Process analytical technology PCT Primary care trust PDE Personal daily exposure PER Pharmaceutical evaluation report PGD Patient group direction PI Prescribing information PI Production information PIL Patient information leaflet PIM Product information management (EMA) PIP Paediatric investigation plan PMS study Post-marketing safety study PMS Postmarket(ing) surveillance POM Prescription-only medicine POM to P Prescription-only medicine to pharmacy PPI Patient and Public Involvement (UK) PRAC Pharmacovigilance Risk Assessment Committee PRSPH Potential serious risk to public health PSMF Pharmacovigilance system master file PTE Patent term extension PUMA Paediatric-use marketing authorization PV Pharmacovigilance PVAR Preliminary Variation Assessment Report Q QA Quality assurance QbD Quality by design QC Quality control QMS Quality management system QOL Quality of life QoS Quality overall summary QP Qualified person QPPV Qualified person for pharmacovigilance QRD Quality review of documents R RA Regulatory affairs RCFID Registration Certificate for Import of Drug RCT Randomised controlled trial RDE Remote data entry RDS Repeat dose study RDT Rising-dose tolerance REACH Registration, evaluation, authorisation and restriction of chemicals RI Regulatory intelligence RING Regulatory Intelligence Network Group rINN Recommended international non-proprietary name RMM Risk minimisation measure RMP Reference medicinal product RMR Reaction monitoring report RMS Reference Member State ROI Return on investment RoW Rest of world RP Responsible person RPS Regulated product submission Rx Prescription S S+T Sampling and testing SAG Scientific Advisory Group SAP Scientific advice procedure SAWP Scientific Advice Working Party SI Statutory instrument SLA Service level agreement SME Significant medical event SMF Site master file SMO Site management organization SMQ Standardised MedDRA query SOP Standard operating procedure SPIN Special interest network SSC Scientific Steering Committee SWOTs Strengths – weaknesses – opportunities – threats T TAG Therapeutic Advisory Group TLV Threshold limit value TOC Table of contents TOD Table of decisions TOPRA The Organisation for Professionals in Regulatory Affairs TPP Target product profile TSE Transmissible Spongiform Encephalopathy U USP United States Pharmacopeia V VAMF Vaccine antigen master file VAI Voluntary action indicated W WC Written confirmation WHO World Health Organization WL Wholesale dealer’s licence WRAC Worldwide Regulatory Affairs Committee Posted by Don at 03:08 87 comments: Email This BlogThis! 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