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)
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.
Active Pharmaceutical Ingredient (API)
Active Pharmaceutical Ingredients (API) refers to an active ingredient that is contained in the medication. See Drug Stubstance.
Abridged Application
Abridged applications are applications where, subject to certain conditions, the applicant is not required to provide the results of pharmacological and toxicological tests or the results of clinical trials. An…
Abbreviated New Drug Application (ANDA)
An ANDA (ANDA) is an abbreviated version of an New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved before October 10, 1962 and…
Adverse Drug Reaction (ADR)
Single or repeated drug administration as well as combination of different drugs administration can cause injury to patients. Adverse Drug Reaction: The detection, assessment, understanding and prevention of ADR are…
Signal Detection
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies,…