research

Regulatory tests using animals are mandatory tests performed by companies/industries to evaluate the safety and the toxicity of new drugs, pharmaceuticals, cosmetics, toiletries, agro-chemicals, etc.

Every new chemical substance/molecule must be tested on animals.

Millions of animals are used each year in regulatory tests across the world.

Each substance/molecule is subjected to a series of test protocols that involve rodents, rabbits, dogs and primates.

Companies have no choice and cannot make independent decisions and have to comply with the regulatory protocols of its country.

If an alternative method is to be used instead of animals, this test must be:
1) Validated by specific scientific centres
2) Accepted by national regulatory agencies.

1) Scientific centres

The European Centre for the Validation of Alternative Methods (ECVAM) and the Interagency Co-ordination Committee for the Validation on Alternative Methods (ICCVAM), based in Europe and USA respectively, have been established with the singular purpose to facilitate the development, validation and regulatory acceptance of new and revised regulatory test methods that reduce, refine, and replace the use of animals in testing.

Only methods that are validated by ECVAM and/or ICCVAM can be used instead of animals in regulatory tests.

2) Regulatory agencies

Methods, once validated, have to be accepted by regulatory authorities like OECD (Organisation for Economic Co-operation and Development), FDA (Food and Drug Administration), USDA (U.S. Department of Agriculture's), EPA (Environmental Protection Agency) and other relevant national regulatory agencies. Then, these tests become replacement alternative tests in regulatory protocols.

Resources

To see the list of validated methods:

iccvam.niehs.nih.gov/methods/review.htm
ecvam.jrc.cec.eu.int

For more information:
IVTIP - In Vitro Testing Industrial Platform: a forum of European companies with an active interest in in vitro testing to replace the use of animals in research, development and regulatory testing.