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Abbreviated New Drug Application (ANDA)

Abridged Application

Active Pharmaceutical Ingredient (API)

Active Substance

Active Substance Master File (ASMF)

Adjuvant

Adverse Drug Reaction (ADR)

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)

Biologic Product

Biologics License Applications (BLA)

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

CE Mark (CE)

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)

Checksum

Chemical Abstracts Service Registry Number (CAS Number)

Chemistry, Manufacturing and Controls (CMC)

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Trial Applications (CTA)

CMC Supplement

Code of Federal Regulations (CFR)

Commitment

Committee for Medicinal Products for Human Use (CHMP)

Common Technical Document (CTD)

Competent Authority

Complete Response Letter

Concerned Member State (CMS)

Controlled Vocabulary

Core Data Sheet (CDASH)

DailyMed

Data Definition File

Data Listings

Data Tabulation Datasets

Decentralised Procedure (DCP)

Define.xml

Device

Digital Application Dataset Integration (DADI)

Digital Signature

Document Type Definition (DTD)

Dosage Form

Dosage Strength

Drug Master File (DMF)

Drug Product (DP)

Drug Substance (DS)

eCopy

eCTD Backbone

eCTD Validation Criteria

Efficacy Supplement

Electronic Application Form (eAF)

Electronic Signature

Electronic Submissions Gateway (ESG)

Envelope

European Directorate for the Quality of Medicines (EDQM)

European Economic Area (EEA)

European Medicines Agency (EMA)

Excipient

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)

Generic Drug

Global Trade Item Number (GTIN)

Grouped Submission

Guidance

Gulf Co-operation Council (GCC)

Health Canada

ICH E3

Identification of Medicinal Products (IDMP)

Indication

Integrated Summary of Efficacy (ISE)

Integrated Summary of Safety (ISS)

Intermediate (or Intermediate Product)

International Council for Harmonisation (ICH)

International Nonproprietary Name (INN)

International Organization for Standardization (ISO)

Investigation New Drug Application (IND)

Investigational Medicinal Product Dossier (IMPD)

Investigator’s Brochure (IB)

Label

Labeling Supplement

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)

Module 1

Module 2

Module 3

Module 4

Module 5

Mutual Recognition Procedure (MRP)

National Competent Authority (NCA)

Nationally Authorised Product (NAP)

New Drug Application (NDA)

Node Extension

Non eCTD Electronic Submission (NeeS)

Novel Excipient

Organisation Management Service (OMS)

Packaged Medicinal Product Identifier (PCID)

Patient Package Insert (PPI)

Pharmaceuticals and Medical Devices Agency (PMDA)

Pharmacopoeia

Pharmacovigilance Risk Assessment Committee (PRAC)

Plasma Master File (PMF)

Predicate Rule

President’s Emergency Plan for AIDS Relief (PEPFAR)

Priority Review

Qualified Person Responsible For Pharmacovigilance (QPPV)

Quality Overall Summary (QOS)

Rapporteur

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

Route of Administration

Sequence

Sequence Number

Signal Detection

Sponsor

Standard for Exchange of Nonclinical Data (SEND)

Statistical Analysis System (SAS)

Structured Product Labeling (SPL)

Study Data Tabulation Model (SDTM)

Study Tagging File (STF)

Subject Profiles

Submission

Substance, Product, Organization, Referentials (SPOR)

Summary of Product Characteristics (SmPC)

Supplement

Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)

Therapeutic Area

Trade Name

Unique Ingredient Identifier (UNII)

Universally Unique IDentifier (UUID)

Variation

Veterinary Non eCTD Electronic Submission (vNeeS)

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