Glossary

3

3Rs

Replacement, Reduction and Refinement

The 3Rs stand for:

  • Replacing the use of animals with non-animal methods where possible.
  • Reducing the number of animals to the minimum necessary to obtain scientifically valid results.
  • Refining practices to minimise the stress and improve the welfare of study animals.
3RsWP

European Medicines Agency (EMA) 3Rs Working Party

The 3Rs Working Party is a platform for 3Rs activities at EMA and across the European Medicines Regulatory Network (EMRN).

The goal of the 3RsWP is to encourage and support increased 3Rs-compliant methodologies.

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A

ASCEPT

Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists

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C

CiVM

Complex in Vitro Models

Complex in vitro models (CIVMs) are advanced 3D lab systems, like organoids, spheroids, bioprinted tissues, and organ-on-a-chip, that mimic the structure, function, and microenvironment of human tissues and organs, providing more physiologically relevant data than traditional 2D cultures for drug development, disease research, and personalised medicine, while reducing reliance on animal testing.

Complement-ARIE

Complement- Animal Research In Experimentation program

CSIRO

Commonwealth Scientific and Industrial Research Organisation

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E

ECCC

Environment and Climate Change Canada

EFPIA

The European Federation of Pharmaceutical Industries and Associations

EMA

European Medicines Agency

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F

FDA

American Food and Drug Agency

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G

GIVIMP

Guidance document on good in vitro method practices

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H

HC

Health Canada

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I

IMRWG3R

International Medicines Regulator's Working Group on 3 Rs

To achieve international 3Rs harmonisation of the requirements for regulatory acceptance of NAMs in the global context, this group consists of regulatory representatives from international medicines regulators, including:

  • USA FDA
  • Canadian Health Canada
  • Switzerland Swissmedic
  • Australian TGA
  • Japan PMDA

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N

NATs, NAMs

NAT: Non-Animal Technologies

NAM: New Approach Methodologies / New Alternative Methods

Non-Animal Technologies, New Approach Methodologies and New Alternative Methods all refer to novel approaches and technologies that are 3Rs-compliant.
They all embrace numerous scientific methodologies aimed to accurately model human biology, including:

  • Laboratory developed and engineered in vitro cellular models such as organoids and organs on a chip.
  • Computational models utilising in silico development of machine learning and artificial intelligence.
  • In chemico methods such as biochemical assays to assess potency.

These methods represent potential alternatives to animal testing to enhance the efficiency and effectiveness of drugs in the non-clinical development phase of new medicines and therapies.

NHMRC

The National Health and Medical Research Council

NIH

American National Institutes of Health

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O

OECD

The Organisation for Economic Co-operation

Organoid

Organoids are small, lab-grown cellular structure that mimic the structure and function of human organs.

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S

SOM

Standardised Organoid Modelling Centre

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T

TGA

Australian Therapeutic Goods Administration

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