Abstract
The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Such an approach is critical to achieve harmonized and more transparent approaches to method validation, peer-review and recommendation, which will ultimately expedite the international acceptance of valid alternative methods or strategies by regulatory authorities and their implementation and use by stakeholders. It also allows achieving greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources. In view of achieving these goals, the International Cooperation on Alternative Test Methods (ICATM) was established in 2009 by validation centres from Europe, USA, Canada and Japan. ICATM was later joined by Korea in 2011 and currently also counts with Brazil and China as observers. This chapter describes the existing differences across world regions and major efforts carried out for achieving consistent international cooperation and harmonization in the validation and adoption of alternative approaches to animal testing.
Keywords
- International cooperation
- Harmonization
- ICATM
- Validation
- Alternative methods
- ECVAM
- ICCVAM
- NICEATM
- JaCVAM
- Health Canada
- KoCVAM
- BraCVAM
- CFDA
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Abbreviations
- AM:
-
Alternative method
- ANVISA:
-
Brazil National Sanitary Agency
- BraCVAM:
-
Brazilian Center for Validation of Alternative Methods
- BSRC:
-
Biological Safety Research Center
- CDC:
-
Centre for Disease Control and Prevention
- CFDA:
-
China Food Drug Administration
- CIQ:
-
China Inspection and Quarantine Bureaux
- CONCEA:
-
Brazilian National Council of the Control of Animal Experimentation (Conselho Nacional de Controle da Experimentação Animal)
- ESAC:
-
EURL ECVAM Scientific Advisory Committee
- ESTAF:
-
EURL ECVAM Stakeholder Forum
- EU-NETVAL:
-
European Union Network of Laboratories for the Validation of Alternative Methods
- EURL ECVAM:
-
European Union Reference Laboratory for Alternatives to Animal Testing
- GLP:
-
Good Laboratory Practice
- HC:
-
Health Canada
- ICATM:
-
International Cooperation on Alternative Test Methods
- ICCR:
-
International Cooperation on Cosmetics Regulation
- ICCVAM:
-
U.S. Interagency Coordinating Committee on the Validation of Alternative Methods
- ICH:
-
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
- JaCVAM:
-
Japanese Center for the Validation of Alternative Methods
- JRC:
-
European Commission Joint Research Centre
- KoCVAM:
-
Korean Center for the Validation of Alternative Methods
- MAD:
-
Mutual Acceptance of Data
- MFDS:
-
Ministry of Food and Drug Safety
- MHLW:
-
Ministry of Health, Labour and Welfare
- MoC:
-
Memorandum of Cooperation
- MoST:
-
Chinese Ministry of Science and Technology
- NC:
-
National Coordinator for the OECD Test Guidelines Programme
- NICEATM:
-
U.S. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods
- NIEHS:
-
National Institute of Environmental Health Sciences
- NIFDS:
-
National Institute of Food and Drug Safety Evaluation
- NIHS:
-
National Institute of Health Sciences
- NTP:
-
National Toxicology Program
- OECD:
-
Organisation for Economic Cooperation and Development
- PARERE:
-
EURL ECVAM Network for Preliminary Assessment of Regulatory Relevance
- REACH:
-
Registration, Evaluation, Authorisation and Restriction of Chemicals
- RENAMA:
-
Brazilian National Network of Alternative Methods (Rede Nacional de Métodos Alternativos)
- SACATM:
-
Scientific Advisory Committee on Alternative Toxicological Methods
- SPSF:
-
Standard Project Submission Form
- TG:
-
Test Guideline
- TGP:
-
Test Guidelines Programme
- TPF:
-
Test Pre-submission Form
- TST:
-
Test Submission Template
- VMG:
-
Validation Management Group (means the same as VMT)
- VMT:
-
Validation Management Team (means the same as VMG)
- WNT:
-
Working Group of the National Coordinators for the Test Guidelines Programme
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Barroso, J. et al. (2016). International Harmonization and Cooperation in the Validation of Alternative Methods. In: Eskes, C., Whelan, M. (eds) Validation of Alternative Methods for Toxicity Testing. Advances in Experimental Medicine and Biology, vol 856. Springer, Cham. https://doi.org/10.1007/978-3-319-33826-2_14
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