Glossary

Abbreviated New Drug Application (ANDA)
Abridged Application
Active Pharmaceutical Ingredient (API)
Active Substance
Active Substance Master File (ASMF)
Adaptive Clinical Trial
Adjuvant
ADME Study
Adverse Drug Reaction (ADR)
Adverse Event
Adverse Event (AE)
Amendment
Analysis Data Model (AdAM)
Analysis Datasets
Anatomical Therapeutic Chemical Classification System (ATC)
Annotated Case Report Form
Annotated ECG waveform data
Annual Report
Applicant
Application Number
Approval Letter
ASEAN Common Technical Document (ACTD)
Audit Certificate
Bioavailability
Biologic Product
Biologics License Applications (BLA)
Blinding / Masking
Case Report Form
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Drug Evaluation and Research (CDER)
Centralised Procedure (CP)
Centrally-Authorised Procedure (CAP)
Certificate of Suitability (CEP)
Certified Copy
Chemical Abstracts Service Registry Number (CAS Number)
Chemistry, Manufacturing and Controls (CMC)
Clinical Data Interchange Standards Consortium (CDISC)
Clinical Study
Clinical Study Report
Clinical Trial Applications (CTA)
Clinical Trial Authorization (CTA)
CMC Supplement
Code of Federal Regulations (CFR)
Combination Product
Committee for Medicinal Products for Human Use (CHMP)
Common Technical Document (CTD)
Complete Response Letter
Concerned Member State (CMS)
Contract Research Organization (CRO)
Controlled Study
Controlled Vocabulary
Core Data Sheet (CDASH)
Corrective And Preventative Action (CAPA)
Crossover Study
DailyMed
Data Definition File
Data Monitoring Committee (DMC)
Data Tabulation Datasets
Decentralised Procedure (DCP)
Digital Application Dataset Integration (DADI)
Digital Signature
Document Type Definition (DTD)
Dosage Form
Dosage Strength
Dose Ranging Study
Double Blind Research Design
Drug Master File (DMF)
Drug Product (DP)
Electronic Application Form (eAF)
Electronic Data Capture (EDC)
Electronic Patient Reported Outcome (ePRO)
Electronic Signature
Electronic Submissions Gateway (ESG)
Electronic Trial Master File (eTMF)
European Directorate for the Quality of Medicines (EDQM)
European Medicines Agency (EMA)
eXtended EudraVigilance Medicinal Dictionary (XEVMPD)
eXtended EudraVigilance Product Report Message (XEVPRM)
Fast Healthcare Interoperability Resources (FHIR)
Food and Drug Administration (FDA)
Generic Drug
Global Trade Item Number (GTIN)
Good Clinical Practice (GCP)
Grouped Submission
Gulf Co-operation Council (GCC)
Health Authority (HA)
Health Canada
Identification of Medicinal Products (IDMP)
Important Protocol Deviation
Independent Ethics Committee
Indication
Informed Consent
Informed consent form (ICF)
Inspection
Inspector
Institutional Review Board (IRB)
Integrated Summary of Efficacy (ISE)
Integrated Summary of Safety (ISS)
Interim Analysis
Intermediate Product
International Council for Harmonisation (ICH)
International Nonproprietary Name (INN)
International Organization for Standardization (ISO)
Interventional Study
Investigation New Drug Application (IND)
Investigational Drug
Investigational Medicinal Product Dossier (IMPD)
Investigational Product (IP)
Investigational Site
Investigator
Investigator’s Brochure (IB)
Label
Labelling
Leaf Element
Leaf Title
Lifecycle Operations
Manufacturing Supplement
Marketing Authorisation Application (MAA)
Marketing Authorisation Holder (MAH)
Medical Device
Medical Dictionary for Regulatory Activities (MedDRA)
Medicines and Healthcare products Regulatory Agency (MHRA)
Monitoring
Monitoring Visit
Monitoring Visit Report
Mutual Recognition Procedure (MRP)
National Competent Authority (NCA)
Nationally Authorised Product (NAP)
New Drug Application (NDA)
Non eCTD Electronic Submission (NeeS)
Observational Study
Organisation Management Service (OMS)
Orphan Drug
Packaged Medicinal Product Identifier (PCID)
Patient Package Insert (PPI)
Patient Registry
Patient-Reported Outcome (PRO)
Pharmaceuticals and Medical Devices Agency (PMDA)
Pharmacopoeia
Pharmacovigilance Risk Assessment Committee (PRAC)
Pivotal Clinical Trial
Placebo
Plasma Master File (PMF)
Predicate Rule
President’s Emergency Plan for AIDS Relief (PEPFAR)
Principal Investigator
Priority Review
Protocol
Protocol Amendment
Protocol Deviation
Qualified Person Responsible For Pharmacovigilance (QPPV)
Quality Overall Summary (QOS)
Query
Randomization
Randomized Allocation
Real World Studies
Reference Listed Drug
Reference Member State (RMS)
Regulated Product Submissions (RPS)
Regulatory Activity
Regulatory Affairs
Regulatory Information Management System (RIM / RIMS)
Regulatory Intelligence
Related Sequence
Rolling Submission
Signal Detection
Single-Blind Research Design
Sponsor
Standard for Exchange of Nonclinical Data (SEND)
Statistical Analysis System (SAS)
Structured Product Labeling (SPL)
Study Coordinator
Study Data Tabulation Model (SDTM)
Study Tagging File (STF)
Subinvestigator
Subject
Subject Number
Subject Profiles
Submission
Substance, Product, Organization, Referentials (SPOR)
Summary of Product Characteristics (SmPC)
Supplement
Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)
Therapeutic Area
TMF Reference Model
Trade Name
Uncontrolled Study
Unique Ingredient Identifier (UNII)
Universally Unique IDentifier (UUID)
Variation
Veterinary Non eCTD Electronic Submission (vNeeS)