Leaf Title
The eCTD content is made up of multiple files. The eCTD contains a """ element for each of these files. The leaf title is used to easily identify the file…
Labelling
All written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.…
Labeling Supplement
According to the FDA, a Labeling Supplement is a supplement to an approved application that contains labeling changes only. Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Label
Display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a…
Investigator’s Brochure (IB)
The Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Includes a…
Investigational Medicinal Product Dossier (IMPD)
The IMP dossier (IMPD) gives information related to the quality of any IMP (i.e. including reference product and placebo), manufacture and control of the IMP, and data from non-clinical studies…
Investigation New Drug Application (IND)
[FDA] An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug…
International Organization for Standardization (ISO)
The International Organization for Standardization (ISO) is a worldwide federation from some 100 countries, with one standards body representing each member country. Member organizations collaborate in the development and promotion…
International Nonproprietary Name (INN)
International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary…
International Council for Harmonisation (ICH)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical…
Intermediate (or Intermediate Product)
For biotechnological/biological products, a material produced during a manufacturing process that is not the drug substance or the drug product but for which manufacture is critical to the successful production…
Integrated Summary of Safety (ISS)
An overall analysis and summary of the safety data required by the FDA for an NDA or BLA.
Integrated Summary of Efficacy (ISE)
[FDA] The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available information regarding effectiveness, delineate strengths…
Indication
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.
Identification of Medicinal Products (IDMP)
Identification of Medicinal Products (IDMP) is a set of international standards that define, characterize and uniquely identify regulated pharmaceutical products during their lifecycles.
ICH E3
ICH guidance on the Structure and content of clinical study reports; aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the…
Health Canada
The department of the Government of Canada responsible for national health policy.
Gulf Co-operation Council (GCC)
The Gulf Co-operation Council (GCC) includes: State of United Arab Emirates, Kingdom of Bahrain, State of Kuwait, Sultanate of Oman, State of Qatar, Kingdom of Saudi Arabia, Republic of Yemen.…
Guidance
A non-binding document issued by an agency representing their current thinking on best practices.
Grouped Submission
A grouped submission is a single submission unit that is applied to more than one submission. Grouped submissions are the only business case for sending a submission unit with more…
Global Trade Item Number (GTIN)
A Global Trade Item Number (GTIN) is a unique and internationally recognized identifier for a product.
Generic Drug
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended…
Food and Drug Administration (FDA)
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and…
File Tag
An identifier chosen from a defined list that is applied to an element in a Study Tagging File that identifies the type of the file. File Tags are defined by…
FDA 356h
FDA form: Application to Market a New or Abbreviated New Drug or Biologic for Human Use
FDA 2253
FDA Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use form submitted to the FDA with all promotional material sequences.
FDA 1571
FDA Investigational New Drug application form. The cover sheet for a US Investigational New Drug (IND) Application, which reports the phase of a proposed study, outlines the allocation of responsibility…
Fast Healthcare Interoperability Resources (FHIR)
The HL7® FHIR® (Fast Healthcare Interoperability Resources 1 ) standard defines how healthcare information can be exchanged between different computer systems regardless of how it is stored in those systems.…
eXtended EudraVigilance Product Report Message (XEVPRM)
The eXtended EudraVigilance Product Report Message (XEVPRM) is the message format for sending XEVMPD messages to EMA.
eXtended EudraVigilance Medicinal Dictionary (XEVMPD)
The Extended EudraVigilance Medicinal Dictionary (XEVMPD) is the EMA’s current database for tracking pharmaceutical product data for drug safety monitoring and tracking. XEVMPD will gradually be phased out and replaced…
Excipient
Any ingredient intentionally added to a drug or biologic that is not intended to have a therapeutic effect but may improve product delivery. Examples of excipients are diluents to increase…
European Medicines Agency (EMA)
An agency of the European Union in charge of the evaluation and supervision of medicinal products.
European Economic Area (EEA)
The European Economic Area (EEA) is a collection of European countries, primarily made up of the EU nations with the addition of other participating countries who share economic and regulatory…
European Directorate for the Quality of Medicines (EDQM)
The EDQM is a leading organisation that protects public health by: enabling the development,supporting the implementation andmonitoring the applicationof quality standards for safe medicines and their safe use which are…
Envelope
Structured information part of the eCTD module 1 specific to the product and the application information (full name, applicant, regulatory activity, type of application, procedure number, etc.).
Electronic Submissions Gateway (ESG)
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions [including eCTD]. The FDA ESG enables the secure submission of premarket…
Electronic Signature
[FDA] Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the…
Electronic Application Form (eAF)
PDF fillable form included in EMA human and vet MAAs and Variations, which will be replaced by DADI. Source: http://esubmission.ema.europa.eu/eaf/
Efficacy Supplement
[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling: Add or modify an indication or claim;Revise…
eCTD Validation Criteria
Criteria published by various Health Authorities that define technical criteria for accepting an eCTD submission. Validation criteria may apply to XML backbones, files, folder structures or other components of the…
eCTD Backbone
The Submission XML Table of Contents file which provides an interface for industry-to-agency transfer of regulatory information that takes into consideration the facilitation of the creation, review, lifecycle management and…
eCopy
An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For details on the eCopy program,…
Drug Product (DP)
[A] finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. Source: 21 CFR 314.3(b)
Drug Master File (DMF)
A drug master file (DMF) is a master file that provides a full set of data on an API. In some countries, the term may also comprise data on an…
Dosage Strength
(1) The proportion of active drug substance to excipient, measured in units of volume or concentration.(2) The strength of a drug product, which indicates the amount of active ingredient in…
Dosage Form
The physical state in which a drug is dispensed for use. For example: a frequent dosage form of procaine is a sterile solution of procaine. The most frequent dosage form…
Document Type Definition (DTD)
A DTD defines the structure and the legal elements and attributes of an XML document. In particular, the XML eCTD DTD (Document Type Definition) defines the overall structure of the…
Digital Signature
An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and…
Digital Application Dataset Integration (DADI)
Network project led by EMA which will replace current PDF based electronic application forms with new web forms.
Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis,…
Medical Device
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis,…
Define.xml
"Define-XML is a file tha metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it provides the metadata for human and animal model datasets using…
Decentralised Procedure (DCP)
An EU Procedure Type in which the competent authority of the lead country reviews and approves the application. Participating EU member states review the application concurrently and agree to approve…
Data Tabulation Datasets
Data tabulations are datasets in which each record is a single observation for a subject. Source: Study Data Specifications (FDA)
Data Listings
"Data listings are datasets in which each record is a series of observations collected foreach subject during a study or for each subject for each visit during the study organizedby…
Data Definition File
The data definition file describes the format and content of the submitted datasets. Source: Study Data Specifications (FDA)
DailyMed
DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements, and medical foods.
Core Data Sheet (CDASH)
Core Data Sheet is an unofficial working document prepared by marketing authorization holders typically containing material relating to safety, indications, dosing, pharmacology, and other information concerning the product. Source: Law…
Concerned Member State (CMS)
In the EU, other countries that review the Application during or after the Reference Member State review.
Complete Response Letter
[FDA] A written communication to an applicant from FDA usually describing all of the deficiencies that the agency has identified in an application or abbreviated application that must be satisfactorily…
Competent Authority
A medicine's regulatory authority in the European Union. Source: EMA Glossary
Common Technical Document (CTD)
The Common Technical Document (CTD) is a format for marketing applications submitted to ICH participating regions, controlling the organization of information in an application.
Committee for Medicinal Products for Human Use (CHMP)
"The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. The CHMP plays a vital role in the authorisation of…
Commitment
"Activities to be performed by or on behalf of a Party or its Affiliates as a condition or in connection with receipt of Regulatory Approval of a Licensed Product in…
Code of Federal Regulations (CFR)
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the United States…
CMC Supplement
See Manufacturing Supplement. [FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in the manufacturing…
Manufacturing Supplement
[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in the manufacturing of the product…
Clinical Trial Applications (CTA)
"In the EU, individual member states review and approve individual applications to run clinical trials within that country. One application is submitted for each clinical trial protocol in each country…
Clinical Data Interchange Standards Consortium (CDISC)
The Clinical Data Interchange Standards Consortium is a standards developing organization dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related…
Chemistry, Manufacturing and Controls (CMC)
That part of pharmaceutical development that deals with the nature of the drug substance and drug product, the manner in which both are made, and the manner by which the…
Chemical Abstracts Service Registry Number (CAS Number)
Chemical Abstracts Service (CAS) Number: A unique accession number assigned by the Chemical Abstracts Service, a division of the American Chemical Society. Other than being guaranteed unique to a given…
Checksum
A checksum is a sequence of numbers and letters used to check data for errors. If the checksum of an original file is known, an algorithm can be used to…
Certificate of Suitability (CEP)
Certificate of Suitability to the monographs of the European Pharmacopoeia. A certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid…
Centrally-Authorised Procedure (CAP)
Another term for Centralised Procedure (CP). "An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs,…
Centralised Procedure (CP)
"An EU Procedure type in which the EMA (European Medicines Agency) reviews and approves the application on behalf of all European Union countries.Certain drugs, such as biotech, HIV, cancer and…
Center for Drug Evaluation and Research (CDER)
The Center for Drugs Evaluation and Research (CDER) is the division of FDA that is responsible for the licensing and regulation of pharmaceuticals (with the exception of biologics).
Center for Devices and Radiological Health (CDRH)
FDA Division that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Source: FDA
Center for Biologics Evaluation and Research (CBER)
The Center for Biologics Evaluation and Research (CBER) is the division of FDA that is responsible for the licensing and regulation of biologic drug products. These are pharmaceuticals that have…
CE Mark (CE)
Authorisation in the European Economic Area (EEA) for the marketing and sale of devices, and specifically within Life Sciences, Medical Devices.
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health in…
Biologics License Applications (BLA)
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Source: FDA
Biologic Product
[FDA] FDA: A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of…
ASEAN Common Technical Document (ACTD)
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted…
Approval Letter
[FDA] A written communication to an applicant from FDA approving an application or an abbreviated application. Source: 21 CFR 314.3(b)
Application Number
The identifier assigned to an application by a Health Authority. Source:
Applicant
"A pharmaceutical company or its agent that is submitting information in support of an application." Source: Harmonised Technical Guidance for eCTD Submissions in the EU
Annual Report
[FDA] Post-NDA report (submission) providing the FDA with a summary of new research data, distribution information and labeling changes plus certain other information form manufacturers. These reports must be filed…
Annotated ECG waveform data
"Annotated ECG waveform data are raw voltage-versus-time data comprising the electrocardiogram recording, to which have been attached the identification of various intervals or other features." Source: Study Data Specifications (FDA)
Annotated Case Report Form
An annotated case report form (CRF) is a blank CRF with annotations that document the location of the data with the corresponding names of the datasets and the names of…
Anatomical Therapeutic Chemical Classification System (ATC)
The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines that is maintained by the World Health Organisation (WHO). The WHO assigns ATC codes to all…
Analysis Datasets
Analysis datasets are datasets created to support results presented in study reports, the ISS and the ISE and to support other analyses that enable a thorough regulatory review. Analysis datasets…
Analysis Data Model (AdAM)
ADaM defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the…
Amendment
"[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally submitted. Major Amendment - an…
Adjuvant
An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s immune response. Source: EMA Glossary
Active Substance Master File (ASMF)
Documentation providing detailed information on the manufacturing of the active substance of a medicine. Source: Electronic Active Substance Master Files (eASMF)
Drug Substance (DS)
[FDA] [An] active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure…
Active Substance
The substance responsible for the activity of a medicine. See Drug Stubstance.