ADME Study
A study characterizing absorption, distribution, metabolism, and excretion (ADME) properties help to explore and explain how pharmacokinetic processes happen, so as to provide safety considerations of a new drug on…
Adaptive Clinical Trial
Clinical trial design that uses accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and integrity of the trial. Source:…
Worksharing
The submission of a single application for a variation that affects more than one marketing authorisation from the same marketing authorisation holder. Source: Worksharing: questions and answers
WebTrader
[FDA] WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully encrypted message to the FDA,…
Veterinary Non eCTD Electronic Submission (vNeeS)
VNeeS format is the submission format for veterinary products in the EU.Electronic submission in the VNeeS format is mandatory for submissions to EMA as well as for submissions in the…
Variation
[EMA] a change to the terms of a marketing authorisation. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.…
Universally Unique IDentifier (UUID)
A universally unique identifier (UUID) is a 128-bit label used for information in computer systems. Ex: 123e4567-e89b-12d3-a456-426614174000 In eCTD EU dossiers, the UUID is linking the sequence to the eCTD…
Unique Ingredient Identifier (UNII)
A unique ingredient identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the…
Trade Name
The words, names, slogans, pictures or symbols that are used to identify a company. In common usage, trade name is often used inappropriately for brand name and trademark. This name…
Therapeutic Area
A grouping of similar diseases or conditions under a generalised heading, eg diabetes, oncology, cardiovascular.
Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)
Systemized NOmenclature of Medicine - Clinical Terms (SNOMED-CT) is the most precise, comprehensive, standardized, multilingual clinical health terminology product in the world, owned and distributed around the world by The…
Supplement
[FDA] A request to FDA to approve a change to an approved license application. See definitions for individual types of supplements. Source: SOPP 8401.2: Administrative Processing of BLA and NDA…
Summary of Product Characteristics (SmPC)
The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms, and known adverse reactions, amongst…
Substance, Product, Organization, Referentials (SPOR)
A Task Force of Industry, NCAs, EMA, and SMEs who advise and provide recommendations on planning, development, implementation, and maintenance of IDMP standards in the EU.
Submission
A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application
Subject Profiles
Subject profiles are displays of study data of various modalities collected for an individual subject and organized by time. Source: Study Data Specifications (FDA)
Study Tagging File (STF)
The Study Tagging File (STF) is an xml file that should be provided with the eCTD submission of any file, or group of files belonging to a study in Modules…
Study Data Tabulation Model (SDTM)
SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates…
Structured Product Labeling (SPL)
The electronic format by which content of labeling should be submitted to the FDA. SPL utilizes Extensible Markup Language (XML). Source: FDA
Statistical Analysis System (SAS)
SAS is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation, and predictive analytics. SAS datasets and other elements are…
Standard for Exchange of Nonclinical Data (SEND)
SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. SEND is one of the…
Sponsor
ICH: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. According to US 21 CFR 50.3, a corporation or agency…
Sequence Number
The unque four digit number associated with an eCTD sequence, normally beginning with 0000 for the first sequence in an application.
Sequence
A single set of information and / or electronic documents submitted at one particular time by the applicant as a part of, or the complete application .Any collection of content…
Route of Administration
A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the CDER Data…
Rolling Submission
[FDA] In a rolling submission (also known as rolling review), a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review…
Related Sequence
Sequences may be related to one another within one regulatory activity. The related sequence number should always be stated. In case of activities with only one sequence the same sequence…
Regulatory Intelligence
Act of gathering and analyzing regulatory information and monitoring current regulatory climate and using this data to generate creative and innovative regulatory strategies designed to obtain and maintain product approvals…
Regulatory Information Management System (RIM / RIMS)
Regulatory Information Management refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products across the life sciences value chain. Source: DIA - RIM…
Regulatory Affairs
The department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the…
Regulatory Activity
A public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity. An independent regulatory agency is a regulatory…
Regulated Product Submissions (RPS)
A Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. Now generally known as eCTD Version 4.
Reference Member State (RMS)
[EMA] The European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure. Source: EMA Glossary
Reference Listed Drug
[FDA] The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Source: 21 CFR 314.3(b)
Rapporteur
[EMA] One of the two members of a committee or working party who leads the evaluation of an application. Source: EMA Glossary
Quality Overall Summary (QOS)
The Quality Overall Summary (QOS) is a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications
Qualified Person Responsible For Pharmacovigilance (QPPV)
An individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU.
Priority Review
[FDA] Designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, where the time it takes FDA to review a new…
President’s Emergency Plan for AIDS Relief (PEPFAR)
United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease.
Predicate Rule
[FDA] A previously published set of rules with the exception of part 11 (such as GLPs, GCP, or cGMPs) that mandate what records must be maintained, the required contents of…
Plasma Master File (PMF)
The plasma master file (PMF) is a compilation of all the required scientific data on the quality and safety of human plasma relevant to the medicines, medical devices and investigational…
Pharmacovigilance Risk Assessment Committee (PRAC)
[EMA] The European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. Source: Pharmacovigilance Risk Assessment Committee (PRAC)
Pharmacopoeia
A pharmacopoeia is a book describing drugs, chemicals, and medicinal preparations which is issued by an officially recognized authority and serves as a standard.
Pharmaceuticals and Medical Devices Agency (PMDA)
The Pharmaceuticals and Medical Devices Agency is an Independent Administrative Institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan.
Patient Package Insert (PPI)
[FDA] Patient labeling that is part of the FDA-approved prescription drug labeling. PPIs are developed by the manufacturer, approved by the FDA, and are required to be dispensed with specific…
Packaged Medicinal Product Identifier (PCID)
[SPOR] Uniquely identifies a Medicinal Product based on its packaging. This implies one MPID can be associated with more than one PCID, if the same Medicinal Product has more than…
Organisation Management Service (OMS)
[SPOR] The OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes. It stores master data…
Novel Excipient
A material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive Ingredient Database (IID)) or that…
Non eCTD Electronic Submission (NeeS)
In general, a submission that uses the eCTD folder structure and file naming conventions but does not include an XML backbone.
Node Extension
Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the eCTD structure and should be…
New Drug Application (NDA)
A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. Source: New…
Nationally Authorised Product (NAP)
[EMA] A medicine authorised in a Member State in accordance with its national authorisation procedure. Source: Nationally Authorised Product
National Competent Authority (NCA)
[EMA] A medicines regulatory authority in a European Union Member State. Source: National Competent Authority
Mutual Recognition Procedure (MRP)
An EU Procedure Type in which the competent authority of the lead EU country reviews and approves the application. Other EU member states agree to “recognize” and approve the application…
Module 2
CTD Module of the quality/non clinical/clinical summaries documents.
Medicines and Healthcare products Regulatory Agency (MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that…
Medical Dictionary for Regulatory Activities (MedDRA)
A clinically validated international medical terminology dictionary used by regulatory authorities in the pharmaceutical industry during the regulatory process, e.g., pre-marketing, post-marketing, data entry.
Marketing Authorisation Holder (MAH)
The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. Source: Marketing Authorisation Holder
Marketing Authorisation Application (MAA)
An application made to a European regulatory authority for approval to market a medicine within the European Union. Also use din other markets and as a general term. Source: EMA…
Lifecycle Operations
The operation attribute gives the status of the new file (where applicable) in relation to what has been submitted previously, and it has the following possible values: "new" - the…
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…