Workshop Waiving animal testing for regulatory purposes

Paris (France), September 1st, 2011

Ministère de l'Enseignement Supérieur et de la Recherche
Amphithéâtre Gay-Lussac
1 rue Descartes 75005 Paris

Please, note that you will need an ID to enter in the meeting room



Why this workshop?
To gather scientists and regulatory experts in charge of the development of tools and methodologies necessary for regulatory files experts or experts in charge of the regulatory control of products in order to exchange on the existing possibilities for waiving animal testing.

Questions to be addressed:

  • What are the current uses of waiving?
  • What efficiency in terms of reduction?
  • Which are the barriers to overcome?
  • What are the current scientific and technological needs?
The concept of waiving

 In the field of chemicals and therapeutic drugs regulations, the concept of waiving aims at eliminating animal testing in specific cases or at replacing animal testing by other approaches. These different approaches for waiving animal testing may be:
  • The weight of evidence
  • A negligible and/or non relevant exposure
  • The use of alternative in vitro tests
  • The use of in silico methods (QSARs) and read-across
Waiving is applicable in a regulatory framework only.
Waiving may be defined as the possibility to avoid animal testing required by the regulation and thus is considered as an alternative method.
It potentially affects 3 millions of animals per year in the European Union.

The context of waiving

Except for the cosmetic products domain, all regulations and guidelines assessing the efficacy and/or safety of human and veterinary medicines, chemicals, food additives, biocides, plant protection products (crops) require animal testing. However, the limitation and/or substitution of animal experimentation are currently largely promoted and encouraged by regulatory bodies.
This position is included in a general strategy of the Commission and member states on animal experimentation by encouraging the development of alternative methods (art 47 of the European Directive 2010/63/UE adopted on the 22 of September 2010 which revise the Directive 86/609/CEE on the protection of animals used for experimental and other scientific purpose.

Summary of the workshop program

In the first session, representatives from international and European agencies will present the regulatory context of the limitation of animal testing and the progress already achieved in the different sectors.
Representatives from industry will present in a second session concrete examples of waiving, in particular with regard to the availability of alternative in vitro methods. Scientific strategies and regulatory aspects will be discussed.
This workshop will end by a round table, and the outcome of the discussion will result in a report and recommendations published by FRANCOPA.