Month: May 2022

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

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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

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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

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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

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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

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Submission

A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application

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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)

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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;

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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

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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

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Sequence Number

The unque four digit number associated with an eCTD sequence, normally beginning with 0000 for the first sequence in an application.

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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

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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

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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

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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

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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

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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

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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

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Rapporteur

[EMA] One of the two members of a committee or working party who leads the evaluation of an application. Source: EMA Glossary

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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Indication

A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.

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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

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Guidance

A non-binding document issued by an agency representing their current thinking on best practices.

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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

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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,

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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.

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FDA 356h

FDA form: Application to Market a New or Abbreviated New Drug or Biologic for Human Use

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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.

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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,

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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

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