Let’s Talk Regulatory: A Glossary of the most important Regulatory Abbreviations and Definitions
API
Active Pharmaceutical Ingredient
Biologically active component in a pharmaceutical drug product, responsible for its therapeutic effect.
ASMF
Active Substance Master File
Document containing detailed information about the manufacturing, control, and properties of an active substance used in a pharmaceutical product.
ADR
Adverse Drug Reaction
Harmful and unintended reaction that occurs at a dose normally used for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.
AE
Adverse Event
Any unfavorable and unintended sign (incl. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether related to the medicinal (investigational) product.
AEMPS
Agencia Española de Medicamentos y Productos Sanitarios
The Spanish Medicines Agency
AMA
African Medicines Agency
Proposed specialized agency of the African Union (AU) intended to facilitate the harmonization of medical regulation. Following a similar model to that of the EMA, it is intended to have a wide scope covering medicines, traditional medicine, and medical devices.
AMRH
African Medicines Regulatory Harmonisation
Initiative to respond to national medicines regulatory challenges. Its main aim is to create more effective, efficient, and transparent regulatory mechanisms in various African markets through collaborative regional mechanisms that, among others, achieve faster medical product approvals. Proposes to serve as foundation for the establishment of the African Medicines Agency (AMA). The goals of the model law include increasing collaboration across countries and facilitation of the overall regional harmonization process.
ANDA
Abbreviated New Drug Application
Contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
ANDS
Abbreviated New Drug Submission
Written request to Health Canada to obtain marketing approval for a generic drug.
API (Regulatory)
Active Product Ingredient
Substance in a pharmaceutical product that is biologically active.
API (Software)
Application programming Interface
Specification intended to be used as an inter-face by software components to communicate with each other.
Application
Collection of electronic documents compiled by a pharmaceutical company or its agent in compliance with the (national) legislation and guidelines.
APQR
Annual Product Quality Review
Prepared in pharmaceutical to review the consistency of the products annually regarding their quality including the deviations, change controls and market complaints.
ASM
Active Substance Manufacturer
Company that produces and sells substances.
ASMF
Active Substance Master File
Drug substance documentation; formerly known as European Drug Master File (EDMF). US equivalent: DMF.
ATC
Anatomical, Therapeutic, ChemicalCompany that produces and sells substances.
WHO’s classification of drug substances that divides drugs into different groups according to organ or system on which they act and/or their therapeutic and chemical characteristics.
Audit Trail
Secure, computer-generated, time-stamped record of events, changes, or actions within a system, essential for traceability and accountability.
Backbone
XML backbone of an eCTD dossier forms the container for the contained files, information and hyperlinks that make up the submission.
BAID
Medicinal Product Batch Identifier used in IDMP to identify medicinal products
BAID (1) = Medicinal Product Batch Identifier (outer packaging) BAID (2) = Medicinal Product Batch Identifier (immediate packaging)
Baseline eCTD
Used for submission to the drug regulatory authority to switch to the eCTD format for an already approved drug with a dossier in an old format.
CAP
Centralized Authorized Product
EU-wide procedure for the authorization of medicines, where there is a single application, a single evaluation, and a single authorization throughout the EU. Only certain medicines are eligible for it.
CAPLA/CANDA
Computer Assisted Product Licence Application/ Computer Assisted New Drug Application
Means of submitting product license applications by computer.
CBE
Changes Being Effected
The CBE-0 is a supplement submission for certain moderate changes for which distribution can occur when FDA receives the supplement as provided in 21 CFR 314.70 and 21 CFR 601.12.
CCDS
Company Core Data Sheets
Prime reference document of drugs, the central document regulators and resellers rely on to label and manage the drug's use.
CDER
Center for Drug Evaluation and Research
Part of the U.S. FDA regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
CEP
European Certificate of Suitability
Certifies the suitability of the relevant Ph. Eur. monograph to control the quality of the Active Product Ingredient produced by the manufacturer specified in the CEP.
CMS
Concerned Member State
Member state involved in European mutual recognition procedures (MRP & DCP) with the licensing process but not the state doing the assessment (RMS).
CAPA
Corrective and Preventive Action
Systematic processes to identify, correct, and prevent deviations or issues in a regulated environment.
CoA
Certificate of Analysis
Document that manufacturers produce to verify the product they manufactured conforms to their customer’s requirements.
CPP
Critical Process Parameter
Key variables in a manufacturing process that significantly affect the quality and characteristics of a pharmaceutical product.
CTD
Common Technical Document
Set of specifications for an application dossier for the registration of Medicines, designed to be used across Europe, Japan and the U. S. and beyond. It basically defines structure and format of the submission dossier.
CV
Controlled Vocabulary
Lists of terms that refer to attributes of medicinal and pharmaceutical products, e.g. dosage form, route of administration, unit of measurement.
DADI
Digital Application Dataset Integration
DADI will replace current PDF-based electronic application forms (eAF) with new web-forms in a new eAF portal.
DCP
Decentralised Procedure
Applicable in cases where an authorization does not yet exist in any of the EU Member States.
DMF
Drug Master File
Submission to regulatory authorities providing detailed information about the manufacturing, composition, and quality of a drug substance.
Dossier
Collection of documents and information submitted to regulatory authorities for product approval or compliance.
eAF
electronic application form
Word-based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardized catalogue terms, built in business rule validation, and support for validation of form, etc.
eCTD
electronic Common Technical Document
Digital format for the submission of regulatory information that is used in electronic submissions to regulatory authorities.
EDQM
European Directorate for the Quality of Medicines
Directorate of the Council of Europe, the continent's leading human rights organization, in charge of ensuring the basic human right of access to good quality medicines and healthcare in Europe.
eDMS
electronic Document Management System
System for managing, storing, and tracking electronic documents in a regulated environment.
Envelope
Region/country specific (as part of the administrative information), contains information requested by the specific authority (e.g. Applicant, ATC, Invented Name). The "eu-envelope" element is designed to be used for all types of submissions (initial, variations, renewals, etc.) for a given medicinal product. Mainly used for the first simple processing at the agency level
EOF
National Organization for Medicines, Greece
eOB
electronic Orange Book
List of approved drugs (U. S.)
EoP
End of Procedure
At the end of a MR or DC procedure, the RMS sends an EoP letter to the Applicant with some details as discussed during the procedure, e.g. start and end date, common renewal date (CRD), procedure number, RMS & CMS, etc
EUA
Emergency Use Authorization for medicinal products
EUDRA
European Union Drug Regulatory Authorities
Drug regulatory authorities of the European Union
EUDAMED
European Database on Medical Devices
EudraGMP
Community database containing information on all pharmaceutical manufacturers. It includes details of Manufacturing and Importation Authorizations and GMP Certificates. Typically accessed by Inspectorates; write access requires user authentication.
EUDRALINK
Secure message transfer application for communication between EMA, EU Member State drug regulatory agencies and the industry.
EudraVigilance
Data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorization of medicinal products in the EEA
eSignatures
Electronic signatures used to authenticate and validate documents within a regulatory context.
EMA
European Medicines Agency
Regulatory agency responsible for evaluation and supervision of medicinal products in the EU.
XML
Extensible Mark-up Language
Markup language that defines rules for encoding documents in a format that is both human-readable and machine-readable.
FHIR
Fast Healthcare Interoperability Resources
HL7 (messaging) standard for exchanging healthcare information electronically. A set of XML (and/or JSON) health data resources, plus a REST API for accessing them. It describes data formats and elements as so-called "resources" and offers an interface to exchange them.
FDA
Food and Drug Administration
Regulatory agency in the U. S. responsible for protecting and promoting public health through control and supervision of food and drugs.
GCC
Gulf Cooperation Council
A co-operative organization in different domains including health: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE and Yemen
GCC-DR
Drug Registration Initiative of the Gulf Cooperation Council
Initiative to provide Gulf States with safe and effective medications with reasonable price.
Generic Drug Product
Medicine that is developed to be the same as one that has already been authorized. Its authorization is based on efficacy and safety data from studies on the authorized medicine.
GL
“Gelbe Liste” (Yellow List)
Deals with indications for correct use, divisibility, side effects and interactions, dosage information and contraindications of medicinal products. Information on medical devices and non-medicinal products is also listed.
GMO
Genetically Modified Organism
Organism in which the genetic material has been altered in a way that does not occur naturally.
GMP
Good Manufacturing Practice
Set of quality assurance guidelines and procedures to ensure the consistent production of safe and effective pharmaceuticals.
GRAS
Global Substance Registration System
FDA’s GRAS enables efficient and accurate exchange of information on substances through their Unique Ingredient Identifiers (UNIIs) which can be generated in the regulatory life cycle
GPvP
Good Pharmacovigilance Practice
The MHRA Pharmacovigilance Inspectorate is part of the Inspections, Enforcement and Standards Division. It assesses pharmaceutical companies' compliance with UK and EU legislation relating to the monitoring of the safety of medicines.
GIDWG
Global IDMP Working Group
Formed in October 2021 as an outcome of the 2019 IDMP Workshop hosted in Geneva by WHO. Set up to pursue projects leading to the establishment of a framework for the global implementation of the ISO IDMP standards and maintenance of global identifiers. It works with the ISO Technical Committee on Health Informatics Working Group 6 (ISO TC 215 WG6) and the Health Level Seven (HL7) Working Group on global health data interoperability. Members come from EMA, US FDA and UMC, the goal is to expand to a larger working group as IDMP implementation picks up pace.
GSID
General Substance Identifie
GSID is based on ISO 11238 and TS 19844
HAC
Health Authority Commitment
Finalizing a procedure, Agencies may agree that the applicant/MAH must provide additional data at a later stage. They are obliged to later submit further documentation to fulfill the commitment. This can be done e.g. as FUM (Follow-up measure), variation, or as part of another regulatory activity, e.g. renewal. HAC is also known as PAC (Post-Approval Commitment), PAM (Post-Approval Measure), FUM (Follow-up Measure), PMD (Post-Marketing Requirement), PMC (Post-Marketing Commitment), depending on the commitment type and the market.
HHS
United States Department of Health and Human Services
HL7
Health Level 7
Standards development organization (SDO) accredited by ANSI active in healthcare, focusses on development of administrative and clinical standards as CDISC, SPL or RPS.
HMA
Heads of Medicines Agency
Network of the Heads of the NCAs whose organizations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area.
ICD
International Classification of Diseases
Standard diagnostic tool for epidemiology, health management and clinical purposes. This includes the analysis of the general health situation of population groups. It is used to monitor the incidence and prevalence of diseases and other health problems.
ICH
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
Global organization that develops guidelines/ standards for the pharmaceutical industry to ensure safety, efficacy, and quality of medicines
ICH M2 EWG
ICH Multi-disciplinary group 2 (M2) Expert Working Group (EWG)
Group responsible for evaluation and recommendation of Electronic Standards for Transmission of Regulatory Information (ESTRI) between pharmaceutical companies and regulatory authorities.
IDMP
Identification of medicinal products
The ISO IDMP standards specify the use of standardized definitions for identification and description of medicinal products for human use. Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner. They help to ensure wide interoperability across global regulatory and healthcare communities.
IMCA
Icelandic Medicines Control Agency
IMP
Investigational Medicinal Product
Medicinal product that is not yet approved by a health authority. It is a new drug or device which must be authorized for a clinical study.
IMPD
Investigational Medicinal Product Dossier
Document containing information about an IMP to be marketed in the EU. It includes various summaries of information related to quality, manufacture, and control of an IMP (incl. reference product and/or placebo), data from non-clinical studies and from its clinical use, and the product’s developmental phase.
IND
Investigational New Drug
Regulatory submission seeking authorization to conduct clinical trials with an experimental drug in humans.
INFARMED
National Authority of Medicines and Health Products, Portugal
INN
International Nonproprietary Name (WHO)
Used to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name, globally recognized and public property. Also known as a generic name.
IPI
Inactive Pharmaceutical Ingredient
Substance or compound used in manufacture of a pharmaceutical product and does not contribute to the therapeutic effect, but is intended to enhance the consistency, appearance, integrity, stability, release characteristics, or other features of the product.
IRIS
EMA’s online platform to support product-related scientific and regulatory procedures with EMA.
LL
Local Language code (as per Appendix 2.2)
In the context of the eCTD, LCM represents the evolution of a regulatory application including post marketing activities. Technically, the lifecycle is represented by eCTD sequences and operation attributes.
LCM
Lifecycle Management
In the context of the eCTD, LCM represents the evolution of a regulatory application including post marketing activities. Technically, the lifecycle is represented by eCTD sequences and operation attributes.
Leaf element
In the context of the eCTD, LCM represents the evolution of a regulatory application including post marketing activities. Technically, the lifecycle is represented by eCTD sequences and operation attributes.
MA
Marketing Authorization
Authorization granted by regulatory authorities to market and sell a pharmaceutical product.
MAA
Marketing Authorization Application
The process to retrieve a Marketing Authorization. The term may be different in different regions.
MAH
Marketing Authorization Holder
Company or other legal entity that has the authorization to market a medicine in a country.
MCC
Medicines Control Council
Established to oversee the regulation of medicines in South Africa.
MDM
Master Data Management
Single master record for each person, place, or thing in a business, from internal and external data sources and applications. This information has been de-duplicated, reconciled and enriched, thus a consistent, reliable source.
MD5
Message-Digest Algorithm 5
Widely used cryptographic hash function used in a variety of security applications and to check the integrity of files, including eCTD dossiers.
MedDRA
Medical Dictionary for Regulatory Activities
International medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process.
MedWatch
FDA’s reporting system for adverse events. It collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products
Metadata
Descriptive information about documents or data, including details like authorship, creation date, and version.
MHLW
Ministry of Health, Labour and Welfare, Japan
MHRA
Medicines and Healthcare products Regulatory Agency, Great Britain
ML
Manufacturer's Licence
Required by manufacturers of medicinal products in the UK
Module
Main sections of the CTD and the eCTD. Modules 3, 4 and 5 present detailed data related to the Quality, Nonclinical and Clinical information, respectively, of a medicinal product. Module 2 summarizes this information and provides an integrated overall analysis. Module 1 contains administrative and regional information (including the Product Information) and does not belong to the common CTD part.
MPA
Medical Products Agency, Sweden
MRA
Agreements between the EU and third countries to recognize each other’s GMPs.
MRP
Mutual Recognition Procedure
Submission type of the eCTD Lifecycle Management. Procedure type: mutual-recognition. Mutual recognition means EU countries may approve the decision made about a medicinal product by another EU country. The pharmaceutical company submits their application to the country chosen to carry out the assessment work, which then approves or rejects the application. The Concerned Member States (CMS) must decide within 90 days whether they approve or reject the decision made by the Reference Member State (RMS).
NAS
New Active Substance
New chemical or new biological substance.
NB
Notified Body
Certification organization which the Competent Authority of a Member State has designated to carry out in an independent manner one or more of the Conformity Assessment Procedures described in the annexes of the Directives.
NCA
National Competent Authority
Organizations with legally delegated or invested authority, or power to perform a designated function, normally monitoring compliance with the national statutes and regulations.
NDA
New Drug Application
Submitted by a sponsor to FDA when enough evidence on the drug's safety and effectiveness has been obtained. It must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics.
NDS
New Drug Submission
When applying for a medicinal product (with an ingredient not yet approved in CA), an NDS must be submitted. (Compare: ANDS: for an ingredient already on the market > generic application).
NeeS
Non-eCTD electronic Submission
Electronic submission without XML components, developed as a transitional format towards the eCTD (EU only). The structure and naming conventions for files and folders must comply with the eCTD specification.
Node Extension
A way of providing extra organizational information to the eCTD. It should be visualized as an extra heading in the CTD structure and displayed as such when the XML backbone is viewed.
NME
New Molecular Entity
Active ingredient that has never been marketed in the U.S. in any form. It contains no active moiety previously approved by the Agency in an application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act or has been previously marketed as a drug in the U. S
NtA
Notice to Applicants
Document developed to provide applicants for medicinal products clear guidance on the format of submission documents. Also used as term to describe the format of the dossier used prior to CTD and eCTD.
OMS
Organisation Management Services
Services part of the SPOR project to maintain organization related CVs as master data.
Orphan Drug
Drug for a rare disease. The indications for which the product is intended are encountered so rarely that the applicant cannot be expected to provide comprehensive evidence.
OTC
Over-The-Counter products
Medications available without a prescription or intermediary, directly for consumer purchase.
PAC
Post-Approval Commitment
Pls. see HAC (Health Authority Commitment)
PAM
Post-Approval Measure
Pls. see HAC (Health Authority Commitment)
Parallel Import
Pharmaceutical product therapeutically equivalent to an existing licensed UK product and licensed in the UK in accordance with the rules of the parallel import scheme.
PAS
Prior Approval Supplement
Submission to regulatory authorities seeking approval for changes to an already approved drug or medical product, requiring prior authorization before implementation.
PEI
Paul-Ehrlich-Institut
Federal Agency for Sera and Vaccines, Germany
Pharmacovigilance
Technical term used for identifying and responding to risk/benefit issues emerging for authorized medicines as used in clinical practice and including the effective dissemination of such information to optimize the safe and effective use of medicines.
PhPID
Pharmaceutical Product Identification
Unique identifier calculated by an algorithm based on substance identification (ISO 11238), dosage form (ISO 11239) and strengths with units of measurement (ISO 11240), to associate group of relevant medicinal products at specific levels.
PIL
Patient Information Leaflet
Document (leaflet) to be submitted by drug manufacturers and be read before prescribing or taking drugs; provides information such as indications for the respective drug use, adverse effects, and dosage schedules; designed and written for the patient.
PIM
Product Information Management
System for management and exchange of XML-based structured product information in the EU between regulators and applicants to be used within or outside the eCTD. Currently implemented by the EMEA for the Centralized Procedure.
PLM
Product Lifecycle Management
Following the launch of the web-based Human Variation electronic Application Form (eAF) for Centrally Authorized Products (CAPs) on the Product Lifecycle Management (PLM) Portal, users have accessed the PLM Portal to work on variation applications using the new web-form.
PMC
Post-Marketing Commitment
Refer to HAC (Health Authority Commitment)
PMDA
Pharmaceuticals and Medical Devices Agency, Japan
PMR
Post-Marketing Requirement
Refer to HAC (Health Authority Commitment)
PMS
Product Management Services
Services part of the SPOR project to maintain product related CVs as master data.
PPL
Patient Package Insert
Contains information for patients' under-standing of how to safely use a drug product (US Term).
Procedure
Community registration procedure for the authorization of medicinal products in the European Community. There are 4 types of procedure that operate within the EC – Centralised, Decentralised, Mutual Recognition and National.
PSMF
Pharmacovigilance System Master File
Comprehensive document containing the detailed description of a Marketing Authorization Holders' (MAH's) pharmacovigilance (PV) system ensuring the safety of their products.
PSUR
Periodic Safety Update Reports
Must be submitted once a medical product is registered in the EU. They provide an update of the worldwide safety experience of a medicinal product to Competent Authorities at defined time points post-authorization and are safety documents that refer to Active Ingredients.
PSUSA
PSUR Single Assessment
In the past, PSURs had to be submitted by MAHs to NCAs in regular timeframes, which were calculated according to the initial authorization date. As this caused a heavy workload, it was decided to harmonize the submission dates and check the provided documentation in one single assessment. Submission dates and concerned products (ingredients) are published in the EURD list. PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. EMA carries out PSUSA procedures to assess PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorizations and are authorized in different EU Member States.
PQR
Product Quality Review
Periodic assessment of the quality and performance of a pharmaceutical product throughout its lifecycle.
QbD
Quality by Design
Approach to pharmaceutical development that emphasizes the understanding and control of the product's critical quality attributes
QMS
Quality Management System
Structured system of policies, processes, and procedures designed to ensure quality throughout all stages of a pharmaceutical product's lifecycle.
QOS
Quality Overall Summary
Summary of the quality data included in support of a marketing authorization application for a medicinal product
QPPV
Qualified Person responsible for Pharmacovigilance Activities
Regulatory Activity
Comprises a collection of eCTD lifecycle sequences covering the start to the end of a specific business process, e.g. an initial MA application or Type II variation. A concept used in some review tools to group together several business-related sequences
Regulatory Agency
Federal agency that promulgates and oversees regulations covering a particular aspect of life.
Renewals
A marketing authorization is valid for a specified time only and may be renewed based on a reevaluation of the benefit/risk balance by the competent authority of the authorizing Member State.
RIMS
Regulatory Information Management System
Systems in the regulatory field were built as silos for a specific purpose. RIMS allows the interaction of the system among each other to allow efficient end-to-end processes.
“Rote Liste” (Red List)
List of medicinal products. Contains brief information on medicinal products for human use marketed in Germany (incl. EU MAs) and certain medical devices, compiled from technical, use, and product information. Aims at medical-pharmaceutical professionals. Find more information here: https://www.rote-liste.de/.
RMS
Referential Management Services
Services part of the SPOR project to maintain referential related CVs as master data.
RMS
Reference Member State
EU Member State that leads the review of an application in a mutual recognition procedure or decentralized procedure. Also refer to: CMS.
RPS
Regulated Product Submission
FDA sponsored project (currently RPS R2) for a submission standard developed by HL7 to support all types of products (drugs, vet meds, devices, food), two-way communication between regulators and applicants and referencing to other applications. Planned to be the basis for an eCTD version 4.0.
RUP
Repeat Use Procedure
A Mutual Recognition Procedure (MRP) may be used after completion of a first MRP or a Decentralised (DCP) procedure for the recognition of a marketing authorization by other Member States (MS) for the same veterinary medicinal product. This procedure is known as 'Repeat Use'.
SAE
Serious Adverse Events
SAR
Serious Adverse Reaction
SARG
South African Regulatory Guidelines
SCP
Submission Content Plan
Place to prepare future submissions, collecting and maintaining the information of what documents are required and when it needs to be created, reviewed, or ready.
SDEA
Safety Data Exchange Agreement
Legal written contractual agreement between two or more parties that ensures that all necessary information on the safety of medicine reaches the MAH quickly and safely so that he can fulfil his legal obligations on time. It defines each party’s responsibilities in PV activities, and it prevents the duplication of activities between different partners.
Section
Structure entities defined in the eCTD standard (approximately 200 depending on the region). They are used to group a dossier.
Sequence
Represents a single set of information/documents in the context of the eCTD that are submitted in 1 lifecycle step of the eCTD at one time. Consecutively numbered in 4 digits, starting with sequence 0000 (initial MAA or baseline) and followed by subsequent sequences (0001, 0002, 000n). They constitute the submission granularity level of a regulatory activity.
SFDA
Saudi Food and Drug Authority
SIAMED
EMA’s product information and application tracking system. Developed as a joint project by EMEA (EMA today) and WHO. Provided free of charge to interested national authorities for any not-for-profit use. EMA´s own database, containing information on CAPs only.
SLC
Structured Labelling Content
Helps to reduce non-compliance risk by eliminating redundant sources of product information, ensuring all documents always contain the correct information and adhere to emerging health authority standards.
SmPC
Summary of Product Characteristics
Document describing a pharmaceutical product in terms of its properties, chemical, pharmacological and pharmaceutical etc. and the clinical use. Contains the properties and the officially approved conditions of use of a medicine. Required within the European Commission before any medicinal product is authorized for marketing and designed and written for the use of the physician. The basis for the PL (Package Information Leaflet). Sometimes referred to as SPC.
SMS
Substance Management Services
Services part of the SPOR project to maintain substances related CVs as master data. CV is used for IDMP and other initiatives in future.
SPC
Supplementary Protection Certificate
An intellectual property right that serves as an extension to a patent right. Applies to specific pharmaceutical and plant protection products that have been authorized by regulatory authorities.
SPL
Structured Product Labeling
Document markup standard approved by Health Level Seven (HL7) and adopted by the FDA as mechanism for exchanging product information between applicants and the FDA. It is included in the US Module 1 (ZIP and image files).
SOP
Standard Operating Procedure
Documented procedure providing step-by-step instructions on how to perform a specific task or process in a consistent and standardized manner.
SPOR
Substances, Products, Organizations, Referentials
Used in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the regulatory and the e-health world. While the ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains. Human and veterinary medicines will use the same SMS, OMS and RMS services in terms of data, format, and processes for submitting/maintaining master data.
STF
Study Tagging File
Specification developed by ICH M2 Working Groups that provides additional heading elements and attributes currently not provided by eCTD DTD. An XML instance controlled by ICH STF DTD, should be provided with the submission of any file, or group of files belonging to a study in Modules 4 & 5. Only required in US, optional, not recommended, in EU.
SUSAR
Suspected Unexpected Serious Adverse Reaction
Serious adverse drug reaction (SAR) that is unexpected or for which the development is uncommon (unexpected issue) observed during a clinical trial and for which there is a relationship with the experimental drug, whatever the tested drug or its comparator.
Swissmedic
Swiss Agency for Therapeutic Products
TGA
Therapeutic Goods Administration
Regulatory body responsible for the oversight and approval of therapeutic goods in Australia.
TIGes
Telematics Implementation Group for electronic submission and ICH Implementation
Responsible in the EU for the development of the eCTD regional standards and their implementation. All National Competent Authorities and the EMA are represented. Works in close collaboration with the ICH M2 EWP responsible for the ICH eCTD specification.
TOC
Table of Content
TOM
Target Operating Model
Serves to define and document future optimization strategies for a company and includes one or more dimensions. These can be processes, operational capabilities, employees, or the organization’s infrastructure. There are different levels of detail possible, from a rough outline of a strategy to a detailed framework that outlines all change activities.
UCOM
Unified Code for Units of Measure
Short form of the Unified Code for Units of Measure – by the Regenstrief Institute. A system of codes for unambiguously representing measurement units to both humans and machines.
UDI
Unique Device Identifier
Unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. it comprises a device identifier (UDI-DI) as well as a production identifier (UDI-PI).
USP DI
United States Pharmacopoeia Drug Index
USR
Urgent Safety Restriction
Util
Utility folder in the eCTD Sequence. Contains technical files (comprises a DTD file and a style sheet to verify that the XML file is syntactically correct, and to visualize it).
UUID
Universally Unique Identifier
Computer-generated number, based on an algorithm to identify the instances submitted by eCTD v4.0, e. g. Submission unit, submission, application, document, etc.
UNICOM
Up-scaling the global univocal identification of medicines
Project helping to ensure that any medicine and its content can be accurately identified anywhere in the world. Focuses on the implementation of the International Organization for Standardization (ISO) suite of IDMP standards.
VAMF
Vaccine Antigen Master File
Variations
Amendment to an existing product license by a license holder or the licensing authority. Variation Type IA, IB, II
Version Control
Systematic management of document versions to ensure that the most current and approved version is used.
VNeeS
Veterinary Non eCTD electronic Submission
Electronic submission format for veterinary products. The folder structure follows NTA Volume 6B. The technical specification for an XML based submission format (eNTA) is currently under development.
WHO
World Health Organization
WinMD5
Tool to generate and compare the MD5 checksum of your copy with this MD5 checksum, to ensure that the DTD has remained unchanged. (The checksum for eCTD DTD is: 1d6f631cc6b6357f0f4fe378e5f79a27)
XEVMPD
Extended EudraVigilance Medicinal Product Dictionary
New term introduced to emphasize the new scope of the EVMPD as defined by Article 57(2) second subparagraph of Regulation (EC) 726/2004 as amended by Regulation (EC) 1235/2010 in course of the new EU Pharmacovigilance legislation. Designed to obtain and manage product report messages for authorized and development medicinal products in EEA according to the XEVPRM specification.
XEVPRM
Extended EudraVigilance Product Report Message
Message format defined for the electronic submission of information on medicines that are authorized in EEA or are used as Investigational (Development) Medicinal Products during a Clinical Trial, developed by EMA. An XML-based message format that defines the structure and data elements required to unambiguously identify a medicinal product. It currently comprises two schema files: one schema defining the overall product report message and one schema defining the data elements for substances included in the medicinal product - the Structured Substance Information (SSI). Can contain references to multiple SSIs as well as attachments in form of electronic documents can be referenced from the XEVPRM. Serves as sort of interim standard until the implementation of the ISO IDMP standards.
XEVPRM_ACK
Extended EudraVigilance Product Report Acknowledgement Message
ZAZIBONA
The Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration where national regulatory authorities jointly assess medicinal product dossiers. Active members include Zambia, Zimbabwe, Botswana, Namibia, Tanzania, Democratic Republic of Congo, Malawi, Mozambique, and South Africa.