Abbreviations, links
& helpful information

Structured

  • Agencies and Organisations
  • Procedures and Submissions
  • Clinical Trials and Development
  • Chemistry – Manufacturing – Controls (CMC)
  • GxP and Quality Management
  • Pharmacovigilance
  • Product Information
  • Health Technology Assessment
  • Intellectual Property
  • Other

Regulatory Legislation

accronyms-definitions-medical-regulatory-shortform

Regulatory and Clinical Glossary

Acronyms and Abbreviations

Please use ctrl + F to search through the Glossary

Alphabetical

A

  • AADA – Abbreviated antibiotic drug application
  • ABHI – Association of British Healthcare Industries
  • ABPI – Association of the British Pharmaceutical Industry
  • ACTD – ASEAN Common Technical Dossier
  • ADI – Acceptable Daily Intake
  • ADR – Adverse Drug Reaction
  • AEMPS - Spanish Agency of Medicines and Medical Devices - aemps.gob.es
  • AE – Adverse Event
  • AIFA - Italian Medicines Agency - aifa.gov.it
  • AIM – Active Ingredient Manufacturer
  • ANDA – Abbreviated New Drug Application
  • ANMAT - National Administration of Drugs, Foods and Medical Devices (Argentine) - anmat.gov.ar
  • ANSM - National Security Agency of Medicines and Health Products (France) - ansm.sante.fr
  • ANVISA - Brazilian Health Regulatory Agency - anvisa.gov.br
  • API – Active Pharmaceutical Ingredient
  • AQL – Acceptable Quality Level
  • AR – Assessment Report (European Union)
  • ASCPT – American Society for Clinical Pharmacology and Therapeutics
  • ASMF – Active Substance Master File
  • ATMPs – Advanced Therapy Medicinal Products

B

  • BA – Bioavailability
  • BAP – Biotechnology Action Programme
  • BfArM – Federal Institute for Drugs and Medical Devices (Germany) - bfarm.de
  • BIND – Biological Investigational New Drug
  • BWP – Biotech Working Party (EMA)

C

  • C&P – Chemistry and Pharmacy
  • CA – Competent Authority
  • CANDA – Computer Assisted New Drug Application
  • CAP – Centrally Authorised Product
  • CAPA – Corrective Action and Preventive Action
  • CC – Candidate Country
  • CCDS – Company Core Data Sheet
  • CCG – Clinical Commissioning Group (UK)
  • CD – Controlled Drug
  • cGLP – Current Good Laboratory Practice
  • cGMP – Current Good Manufacturing Practice
  • Cl – Total Body Clearance
  • CLO – Clinical Overview
  • CLS – Clinical Summary
  • CMC – Chemistry – Manufacturing – Controls
  • CMP – Certificate of Medicinal Product
  • COA – Certificate of Analysis
  • CoFS – Certificate of Free Sale
  • CP – Centralised Procedure (European Union)
  • CP – Comparability Protocol (USA)
  • CPP – Certificate of Pharmaceutical Product
  • CQA – Clinical Quality Assurance
  • CR – Controlled Release
  • CRF – Case Report form
  • CRO – Clinical 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
  • CTR – Clinical Trial Regulation (EU 536)
  • CTS – Common Technical Specification
  • CTX – Clinical Trial Exemption (UK)
  • CVM – Center for Veterinary Medicine (US)

D

  • DAE – Discontinuation due to an Adverse Event
  • DDD – Defined Daily Dose
  • DDPS – Detailed Description of Pharmacovigilance System
  • DGRA – German Association Regulatory Affairs – dgra.de
  • DIA – Drug Information Association - diaglobal.org
  • DMF – Drug Master File
  • DMS – Document Management System
  • 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
  • EDMF – European Drug Master File
  • EDT – Electronic Data Transfer
  • EMA – European Medicines Agency - ema.europa.eu
  • EPL – Effective Patent Life
  • ePSUR – electronic Periodic Safety Update Report
  • ERB – Ethical Review Board
  • ESPAR – Executive Summary Pharmacovigilance Assessment Report
  • EWG – Expert Working Group
  • EWP – Efficacy Working Party

F

  • FDA – Food and Drug Administration (US) – fda.gov
  • FTE – Full Time Equivalent

G

  • GCP – Good Clinical Practice
  • GDP – Good Distribution Practice
  • GGP – Good Guidance Practice
  • GLP – Good Laboratory Practice
  • GMP – Good Manufacturing practice
  • G(P)VP – Good Pharmacovigilance Practice
  • GRB – Global Regulatory Board
  • GRP – Good Regulatory Practice
  • GSP – Good Statistics Practice

H

  • HCP – Healthcare Professional
  • HEOR – Health Economics and Outcomes Research
  • HREC – Human Research Ethics Committee
  • HTA – Health Technology Assessment
  • HTS – High-Throughput Screening

I

  • IB – Investigator’s Brochure
  • ICD/F – Informed Consent Document/Form
  • ICSR – Individual Case Safety Report
  • IDE – Investigational Device Exemption
  • IDMP – Identification of Medicinal Products
  • IEC – Independent Ethics Committee
  • IMI – Innovative Medicines Initiative
  • IMP – Investigational Medicinal Product
  • IMPD – Investigational Medicinal Product Dossier
  • IMRDF – International Medical Device Regulatory Forum
  • IMS – Information Management Strategy
  • 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
  • IRN – Incident Review Network
  • IS – Internal Standard
  • ISE – Integrated Summary of Efficacy
  • ISRB – Integrated Summary of Risk Benefit
  • ISS – Integrated Summary of Safety

K

  • KOL – Key Opinion Leader

L

  • LCM – Lifecycle Management
  • LED – Least Effect Dose

M

  • MA – Marketing Authorisation
  • MAA – Marketing Authorisation Application (EU)
  • MAH – Marketing Authorisation Holder
  • MAIL – Medicines Act Information Letter (UK)
  • MAL – Medicines Act Leaflet (UK)
  • MDCG – Medical Device Coordination Group
  • MDD – Medical Device Directive
  • MDEG – Medical Device Expert Group
  • MDLO – Medical Device Liaison Officer
  • MDR – Medical Device Reporting
  • MERS – Multi-agency Electronic Regulatory System
  • MFDS - Ministry of Food and Drug Safety (Korea) - mfds.go.kr/eng
  • MHRA – Medicines and Healthcare Products Regulatory Agency (UK) - gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
  • ML – Manufacturer’s Licence (UK)
  • MOU – Memorandum of Understanding
  • MPA – Medicines Product Agency (Sweden) - lakemedelsverket.se
  • MRA – Mutual Recognition Agreement

N

  • NAP – Nationally Authorised Product
  • NBE – New Biological Entity
  • 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
  • NMPA - National Medical Products Administration (China) - english.nmpa.gov.cn

O

  • OD – Orphan Drug
  • ODA – Orphan Drugs Act (USA)
  • ODD – Orphan Drug Designation
  • OIA – Official Action Indicated
  • OOS – Out of Specification
  • OTC – Over-the-Counter

P

  • P&R – Pricing and Reimbursement
  • P – Pharmacy only
  • P to GSL – Pharmacy to General Sales List
  • PA – Product Authorisation
  • PAI – Pre-Approval Inspection
  • PAR – Preliminary Assessment Report
  • PASS – Post Authorisation Safety Study
  • PAT – Process Analytical Technology
  • PDE – Personal Daily Exposure
  • PFDD - Patient-Focused Drug Development
  • PI – Prescribing Information
  • PI – Production Information
  • PIL – Patient Information Leaflet
  • PIM – Product Information Management (EMA)
  • PIP – Paediatric Investigation Plan (EMA)
  • PMDA - Pharmaceuticals and Medical Devices Agency (Japan) - pmda.go.jp
  • 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)
  • PRSPH – Potential Serious Risk to Public Health
  • PSMF – Pharmacovigilance System Master File
  • PSP – Paediatric Study Plan (FDA)
  • PTE – Patent Term Extension
  • PUMA – Paediatric-Use Marketing Authorisation
  • 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 [template]

R

  • RA – Regulatory Affairs
  • RCT – Randomised Controlled Trial
  • RDE – Remote Data Entry
  • RDS – Repeat Dose Study
  • 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
  • ROI – Return on Investment
  • RoW – Rest of World
  • RP – Responsible Person
  • RWD – Real World Data
  • RWE – Real World Evidence
  • Rx – Prescription

S

  • S+T – Sampling and Testing
  • SAG – Scientific Advisory Group
  • SAP – Scientific Advice Procedure
  • SAWP – Scientific Advice Working Party
  • SMF – Site Master File
  • SMO – Site Management Organisation
  • SmPC – Summary of Product Characteristics
  • SMQ – Standardised MedDRA query
  • SOP – Standard Operating Procedure
  • SPC - Supplementary Protection Certificate
  • SPIN – Special Interest Network
  • SSC – Scientific Steering Committee
  • SWOTs – Strengths – Weaknesses – Opportunities – Threats

T

  • TAG – Therapeutic Advisory Group
  • TGA – Therapeutic Goods Administration (Australia) - tga.gov.au
  • TOC – Table of Contents
  • TOPRA – The Organisation for Professionals in Regulatory Affairs
  • TPP – Target Product Profile

V

  • VAI – Voluntary Action Indicated