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International Harmonization and Cooperation in the Validation of Alternative Methods

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Book cover Validation of Alternative Methods for Toxicity Testing

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.

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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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