Overview

Laptop with screen showing VMRA-SAT Desktop Full Version

The Veterinary Medicines Regulatory Agency Self-Assessment Tool (VMRA-SAT)

The Veterinary Medicines Regulatory Agency Self-Assessment Tool (VMRA-SAT) is a structured, globally applicable diagnostic instrument designed specifically for national authorities responsible for regulating veterinary medicinal products. 

Its primary purpose is to help regulators systematically evaluate the performance and maturity of their veterinary medicines regulatory systems through a self-led, evidence-based process. 

VMRA-SAT is explicitly designed to be country-owned, voluntary and focused on learning and continuous improvement. 

 

Inside the Tool

The video animation below shows the VMRA-SAT desktop software, which is the full version of the tool used by regulatory authorities to undertake a structured self-assessment of their veterinary medicines regulatory systems. 

How it works

The VMRA-SAT assesses the implementation of all core regulatory functions involved in the veterinary medicines lifecycle, including:

  • governance and legal foundations
  • registration and marketing authorisation
  • manufacturing oversight
  • distribution controls
  • pharmacovigilance
  • inspection
  • laboratory testing
  • enforcement


By encompassing these functions within a single framework, VMRA-SAT provides a holistic view of how the regulatory systems operate in practice, highlighting interdependencies and areas where weaknesses in one function may undermine others. 

The VMRA-SAT uses clear indicators and structured guidance to support consistent interpretation across countries and users. This helps regulators to move beyond informal, reactive self-reflection to a more systematic understanding of regulatory performance.

The structured design of the tool enables effective dialogue across the departments and organisations involved in implementing the national veterinary medicines regulatory framework. It promotes organisational alignment, strengthens institutional memory, and helps address challenges arising from fragmented documentation and inconsistent application of processes.

VMRA-SAT is available as the Full Version (Desktop) and as the Lite Web Version (WebApp). You can read about the two versions here.

VMRA-SAT Versions »

 

The VMRA-SAT structure

VMRA-SAT uses a clear and structured assessment hierarchy based on functions, indicators and sub-indicators.


VMRA-SAT uses a clear assessment structure that moves from broad regulatory responsibilities to detailed requirements. It is organised into Functions, Indicators and Sub-indicators, allowing a national regulatory authority to examine both its overall regulatory system and the individual arrangements that support it. This structure helps users identify strengths, recognise gaps and understand where improvement may be needed.

Functions

The eight functions represent the main responsibilities involved in regulating veterinary medicines. They cover the national regulatory system, registration and marketing authorisation, pharmacovigilance, market surveillance and control, licensing of establishments, regulatory inspection, laboratory testing and batch release. Together, they provide a comprehensive view of the veterinary medicines regulatory system.

Indicators

Each Function is divided into indicators. Indicators describe the main elements that should be in place for a regulatory responsibility to operate effectively. These may relate to areas such as legislation, governance, leadership, quality management, human resources, procedures, infrastructure, transparency and monitoring of performance. There are 13 indicators in total, and not all are included in every function.

Sub-indicators

Indicators are assessed through more detailed sub-indicators. Each of the 235 sub-indicators describes a specific requirement or practice that can be examined during the assessment. Users consider whether the requirement has been implemented and record the information and evidence supporting their judgement.

Each sub-indicator is supported by a Fact Sheet containing information such as its purpose, requirements, suggested evidence, references, assessment criteria and relevant limitations or explanatory notes. This guidance helps users interpret the requirements consistently and base their assessment on verifiable information.

Maturity Levels

Every sub-indicator is assigned to one of five maturity levels. These levels provide a pathway showing how a regulatory system can develop from basic operating arrangements towards more advanced and integrated performance.

Pre-bronze represents the minimum operating capability and the essential foundations needed for a regulatory system to function.

Bronze indicates that elements of a regulatory system exist beyond the minimum foundations.

Silver represents an evolving system that is able to perform essential regulatory functions.

Gold represents a stable, well-functioning and integrated regulatory system.

Gold-plus represents an advanced level of regulatory performance and continuous improvement.

The levels are progressive. Requirements assigned to the earlier levels establish the foundations needed to support the more advanced requirements at later levels. They help an authority understand its current position, establish realistic priorities and monitor regulatory improvement over time.

 

vmra-sat-tool-infographic The VMRA-SAT desktop tool can generate reports (in Word or PowerPoint) that bring together the completed self-assessment into a structured view of the authority’s regulatory maturity. These reports show the assessment results across the core regulatory functions, highlight strengths and gaps, and provide a basis for internal review, discussion with function leads and senior management, and prioritisation of improvement actions. Output: report Self-assessment process Once the software and country data file are open, the user works through each regulatory function, indicator and sub-indicator in turn, using the guidance to judge the authority’s current position. For each sub-indicator, they select the appropriate status, such as implemented, partially implemented, not implemented or not applicable, then record the supporting evidence and a short narrative explaining the basis for that judgement. Where gaps are identified, the user adds proposed improvement actions, responsibilities or timelines as part of the Institutional Development Plan. Regulatory maturity feedback Pre Bronze Bronze Silver Gold Gold + Minimum operating capability Elements of regulatory system exist Evolving system that performs essential regulatory functions Stable well- functioning and integrated regulatory system Advanced level of performance Regulatory functions Major regulatory activities an authority is expected to have, each function representing a distinct area of mandate or responsibility (e.g. marketing authorisation). 8 Indicator areas Translating regulatory functions into assessable areas, reflecting essential system elements (legal provisions, governance, procedures, resources and operational practices). 13 235 Sub-indicators The most granular level of assessment in VMRA-SAT, designed to be objectively verifiable through documentation, processes, records or observed practice.

VMRA-SAT framework

The eight regulatory functions in the VMRA-SAT

Click a card to open the relevant fact sheet in a new tab

01-VRS

Veterinary Medicines National Regulatory System

The overarching framework that underpins all core veterinary medicines regulatory functions.
02-VMA

Veterinary Medicines Registration and Marketing Authorisation

Assessment and authorisation of veterinary medicinal products before they are placed on the market.
03-VPV

Veterinary Medicines Pharmacovigilance

Detection, assessment and prevention of adverse events and other product-related problems.
04-VMS

Veterinary Medicines Market Surveillance and Control

Monitoring products on the market and controlling quality, compliance and substandard products.
05-VLE

Veterinary Medicines Licensing of Establishments

Licensing manufacturers, distributors, wholesalers, importers and retailers across the supply chain.
06-VRI

Veterinary Medicines Regulatory Inspection

Inspection of establishments and activities to verify compliance with regulatory standards and good practices.
07-VLT

Veterinary Medicines Laboratory Testing

Independent quality control and testing to support regulatory oversight and product assurance.
08-VBR

Veterinary Medicines Batch Release

Independent regulatory batch release, particularly for vaccines and other immunological products.