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Competent Authority
A medicine’s regulatory authority in the European Union.
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EMA Glossary
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Glossary
The Life Sciences glossary with terminology, acronyms, for
regulatory, quality, compliance, clinical trials,
and
pharmacovigilance
software.
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Found 371 Results
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Abbreviated New Drug Application (ANDA)
Abridged Application
Absolute Risk
Abuse
Academia
Acceptable Risk
Active Pharmaceutical Ingredient (API)
Active Substance
Active Substance Master File (ASMF)
Active Surveillance System
Adaptive Clinical Trial
Additional Risk Minimisation Measure
Adjuvant
ADME Study
Adoption
Adverse Drug Reaction (ADR)
Adverse Event (AE)
Adverse Event of Special Interest (AESI)
AGREE Instrument
Alert
Amendment
Analysis Data Model (AdAM)
Analysis Datasets
Analysis of covariance (ANCOVA)
Anatomical Therapeutic Chemical Classification System (ATC)
Annotated Case Report Form
Annotated ECG waveform data
Annual Report
Applicant
Application Number
Approval Letter
Arm
Artificial Intelligence (AI)
ASEAN Common Technical Document (ACTD)
Association
Audit Certificate
Auditor
Baseline characteristics
Bayesian
Bayesian confidence propagation neural network (BCPNN)
Benefit
Benefit-Risk Assessments
Benefit-Risk Balance (Effectiveness/Risk)
Binary Analysis
Bioavailability
Biologic Product
Biologics License Applications (BLA)
Biomarker
Blinding / Masking
Bonferroni Correction
Boxed warning (“black box warning”)
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Burden of a risk minimisation activity
Burden to patients
Candidate gene study
Caregiver
Case Report Form
Case report form (CRF)
Case Reports
Causal Relationship
Causality Assessment
Causality assessment
CE Mark (CE)
Censored/Censoring of Data
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
Checksum
Chemical Abstracts Service Registry Number (CAS Number)
Chemistry, Manufacturing and Controls (CMC)
Clinical Data Interchange Standards Consortium (CDISC)
Clinical Development Program
Clinical Study
Clinical Study Report
Clinical Trial Applications (CTA)
Clinical Trial Authorization (CTA)
Clinicaltrials.gov
CMC Supplement
Code of Federal Regulations (CFR)
Combination Product
Commitment
Committee for Medicinal Products for Human Use (CHMP)
Common Technical Document (CTD)
Company Core Data Sheet (CCDS)
Company Core Safety Information (CCSI)
Comparator
Competent Authority
Complete Response Letter
Concerned Member State (CMS)
Contract Research Organization (CRO)
Control
Controlled Study
Controlled Vocabulary
Core Data Sheet (CDASH)
Corrective And Preventative Action (CAPA)
Council for International Organizations of Medical Sciences (CIOMS)
Critical Terms
Crossover Study
DailyMed
Data Definition File
Data Listings
Data Lock Point (DLP)
Data Monitoring Committee
Data Monitoring Committee (DMC)
Data Tabulation Datasets
Decentralised Procedure (DCP)
Dechallenge
Define.xml
Designated Medical Event (DME)
Development core safety information (DCSI)
Development pharmacovigilance and risk management plan
Development Safety Update Report (DSUR)
Developmental International Birth Date (DIBD)
Device
Digital Application Dataset Integration (DADI)
Digital Signature
Disproportionality Analysis
Document Type Definition (DTD)
Dosage Form
Dosage Strength
Dose
Dose-Ranging Study
Double-Blind Research Design
Dropout
Drug Abuse
Drug Master File (DMF)
Drug Product (DP)
Drug Substance (DS)
eCopy
eCTD Backbone
eCTD Validation Criteria
Efficacy
Efficacy Supplement
Electronic Application Form (eAF)
Electronic Data Capture (EDC)
Electronic Patient Reported Outcome (ePRO)
Electronic Signature
Electronic Submissions Gateway (ESG)
Endpoint
Enrollment
Envelope
EUDRAGENE
EudraVigilance
European Directorate for the Quality of Medicines (EDQM)
European Economic Area (EEA)
European Medicines Agency (EMA)
Excipient
Exclusion Criteria
Expected Adverse Drug Reaction
Expedited Reporting
eXtended EudraVigilance Medicinal Dictionary (XEVMPD)
eXtended EudraVigilance Product Report Message (XEVPRM)
Fast Healthcare Interoperability Resources (FHIR)
FDA 1571
FDA 1572
FDA 2253
FDA 356h
File Tag
Food and Drug Administration (FDA)
Frequency of ADRs
Generic Drug
Global Trade Item Number (GTIN)
Good Clinical Practice (GCP)
Good Pharmacovigilance Practice
Grouped Submission
Guidance
Gulf Co-operation Council (GCC)
Harm
Hazard
Health Authority (HA)
Health Canada
ICH
ICH E3
Identification of Medicinal Products (IDMP)
Identified Risk
Important Medical Event (IME)
Important Protocol Deviation
Important Risk
Incidence
Inclusion Criteria
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 (or Intermediate Product)
International Birth Date (IBD)
International Council for Harmonisation (ICH)
International Nonproprietary Name (INN)
International Organization for Standardization (ISO)
International Serious Adverse Events Consortium (SAEC)
Interventional Study (Clinical Trial)
Investigation New Drug Application (IND)
Investigational Drug
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug Application (IND)
Investigational Product (IP)
Investigational Site
Investigator
Investigator’s Brochure (IB)
Label
Labeling Supplement
Labelling
Leaf Element
Leaf Title
Lifecycle Operations
Lost to Follow Up
Manufacturing Supplement
Marketing Authorisation Application (MAA)
Marketing Authorisation Holder (MAH)
Medical Device
Medical Dictionary for Regulatory Activities (MedDRA)
Medication Error
Medicines and Healthcare products Regulatory Agency (MHRA)
Minimum Criteria for Reporting
Missing Information
Module 1
Module 2
Module 3
Module 4
Module 5
Monitoring
Monitoring Visit
Monitoring Visit Report
Multicenter Trial
Mutual Recognition Procedure (MRP)
National Competent Authority (NCA)
National Pharmacovigilance Centers or National Competent Authority (NCA)
Nationally Authorised Product (NAP)
NCT Number
Near-Misses
New Drug Application (NDA)
Node Extension
Non eCTD Electronic Submission (NeeS)
Novel Excipient
Number Needed to Harm (NNH)
Observational Study
Odds and Odds Ratio
Off-Label Use or Misuse
Organisation Management Service (OMS)
Orphan Drug
Overdose
Packaged Medicinal Product Identifier (PCID)
Patient Package Insert (PPI)
Patient Registry
Patient-Reported Outcome (PRO)
Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Pharmaceuticals and Medical Devices Agency (PMDA)
Pharmacoepidemiology
Pharmacokinetics
Pharmacology
Pharmacopoeia
Pharmacovigilance
Pharmacovigilance Master File
Pharmacovigilance Risk Assessment Committee (PRAC)
Pharmacovigilance System
Phase
Phase 0 (aka Early Phase 1)
Phase 1
Phase 2
Phase 3
Phase 4
Pivotal Clinical Trial
Placebo
Plasma Master File (PMF)
Post-Authorization Safety Study (PASS)
Postmarketing Surveillance
Potential Risk
Predicate Rule
Predisposing Factors
Prescription Event Monitoring (PEM)
President’s Emergency Plan for AIDS Relief (PEPFAR)
Prevalence
Principal Investigator
Priority Review
Product Management Service (PMS)
Protocol
Protocol Amendment
Protocol Deviation
QPPV
Qualified Person Responsible For Pharmacovigilance (QPPV)
Quality Overall Summary (QOS)
Query
Randomization
Randomized Allocation
Rapporteur
Rational Drug Use
Real World Studies
Rechallenge
Recruitment
Reference Listed Drug
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