International Harmonization and Cooperation in the Validation of Alternative Methods

  • João Barroso
  • Il Young Ahn
  • Cristiane Caldeira
  • Paul L. Carmichael
  • Warren Casey
  • Sandra Coecke
  • Rodger Curren
  • Bertrand Desprez
  • Chantra Eskes
  • Claudius Griesinger
  • Jiabin Guo
  • Erin Hill
  • Annett Janusch Roi
  • Hajime Kojima
  • Jin Li
  • Chae Hyung Lim
  • Wlamir Moura
  • Akiyoshi Nishikawa
  • HyeKyung Park
  • Shuangqing Peng
  • Octavio Presgrave
  • Tim Singer
  • Soo Jung Sohn
  • Carl Westmoreland
  • Maurice Whelan
  • Xingfen Yang
  • Ying Yang
  • Valérie Zuang
Chapter

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 

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

References

  1. Adler S et al (2011) Alternative (non-animal) methods for cosmetics testing: current status and future prospects. Arch Toxicol 85:367–485CrossRefPubMedGoogle Scholar
  2. Brasil (2008) Lei No. 11.794, de 08 de outubro de 2008. Diário Oficial [da República Federativa do Brasil], de 09 de outubro de 2008, Brasília, Brasil: República Federativa do Brasil (In Portuguese)Google Scholar
  3. Cardoso C, Presgrave O (2010) Princípios éticos na experimentação animal. In: Biologia, Manejo e Medicina de Primatas Não Humanos na Pesquisa Biomédica (Orgs Andrade A, Andrade MCR, Marinho AM, Filho JF). Editora FIOCRUZ, Rio de Janeiro, pp 435–449 (In Portuguese)Google Scholar
  4. CFDA (2011) Note on the management and the notification process of domestic non-special use cosmetics. Record: [2011] No. 181, issued on 21st April 2011 (In Chinese)Google Scholar
  5. CFDA (2014) A further clarification letter on the implementation issues of cosmetic registration and notification. Record: [2014] No. 70, issued on 11th April 2014 (In Chinese)Google Scholar
  6. Curren R, Jones B (2012) China is taking steps toward alternatives to animal testing. Altern Lab Anim 40:1–2PubMedGoogle Scholar
  7. Eskes C, Sá-Rocha V, Nunes J, Presgrave O, de Carvalho D, Masson P, Rivera E, Coecke S, Kreysa J, Hartung T (2009) Proposal for a Brazilian centre on alternative test methods. ALTEX 26:303–306PubMedGoogle Scholar
  8. European Commission (1986) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Off J Eur Union L358:1Google Scholar
  9. European Commission (1991) Establishment of a European Centre for the Validation of Alternative Methods (CEVMA). Communication from the Commission to the Council and the European Parliament, 6pp. Brussels, Belgium: Commission of the European CommunitiesGoogle Scholar
  10. European Commission (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union, L396, 1Google Scholar
  11. European Commission (2009) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Off J Eur Union L342:59–209Google Scholar
  12. European Commission (2010) Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. Off J Eur Union L276:33–79Google Scholar
  13. Guo J et al (2013) Role of PGC-1α and mitochondrial biogenesis in cardiovascular diseases. Chinese J Pharmacol Bullet 29:1–5 (In Chinese)Google Scholar
  14. Hartung T, Bremer S, Casati S, Coecke S, Corvi R, Fortaner S, Gribaldo L, Halder M, Hoffmann S, Roi AJ, Prieto P, Sabbioni E, Scott L, Worth A, Zuang V (2004) A modular approach to the ECVAM principles on test validity. Altern Lab Anim 32:467–472PubMedGoogle Scholar
  15. ICCVAM (2003) ICCVAM guidelines for the nomination and submission of new and revised alternative test methods. NIH publication No. 03-4508. National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, 50 ppGoogle Scholar
  16. MoST of P. R. China (1997) “Opinions on laboratory animal science development”, the Ninth Five-Year Plan on National Economy and Social Development. Policy No (1997—No. 432) (In Chinese)Google Scholar
  17. National Research Council (2007) Toxicity testing in the twenty-first century: a vision and a strategy. The National Academies Press, Washington, DCGoogle Scholar
  18. Ni X (2015) China’s research and development spend. Nature 520:S8–S9. doi:10.1038/520S8a CrossRefPubMedGoogle Scholar
  19. OECD (2005) Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. OECD Series on Testing and Assessment No. 34. ENV/JM/MONO(2005)14, 96pp. Organisation for Economic Co-operation and Development, ParisGoogle Scholar
  20. Presgrave O (2008) The need for the establishment of a Brazilian Center for the Validation of Alternative Methods (BraCVAM). Altern Lab Anim 36:705–708PubMedGoogle Scholar
  21. Presgrave O, Bhogal N (2005) EMALT: a Brazilian meeting on alternative methods to animal use for regulatory purposes. Altern Lab Anim 33:670–672PubMedGoogle Scholar
  22. Presgrave O, Eskes C, Presgrave R, Alves E, Freitas J, Caldeira C, Gimenes I, Silva R, Nogueira S, Nunes J, Rivera E, Sá-Rocha V, Coecke S, Hartung T (2010) A proposal to establish a Brazilian Center for Validation of Alternative Methods (BraCVAM). ALTEX 27:47–51Google Scholar
  23. Stokes WS, Schechtman LM, Hill RN (2002) The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): a review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM). Altern Lab Anim 30(S2):23–32PubMedGoogle Scholar
  24. Yang X et al (2009a) Preliminary study on neutral red uptake assay as an alternative method for eye irritation test. AATEX 14(Special Issue):509–514Google Scholar
  25. Yang Y et al (2009b) Establishment and use of 3T3 NRU assay for assessment of phototoxic hazard of cosmetic products. AATEX 14(Special Issue):515–518Google Scholar
  26. Yang Y et al (2010) Combined in vitro tests as an alternative to in vivo eye irritation tests. Altern Lab Anim 38:303–314Google Scholar
  27. Yuan H et al (2016) A PGC-1α-mediated transcriptional network maintains mitochondrial redox and bioenergetic homeostasis against doxorubicin-induced toxicity in human cardiomyocytes: implementation of TT21C. Toxicol Sci 150(2):400–417CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • João Barroso
    • 1
  • Il Young Ahn
    • 2
  • Cristiane Caldeira
    • 3
  • Paul L. Carmichael
    • 4
  • Warren Casey
    • 5
    • 6
  • Sandra Coecke
    • 1
  • Rodger Curren
    • 7
  • Bertrand Desprez
    • 1
  • Chantra Eskes
    • 8
  • Claudius Griesinger
    • 1
  • Jiabin Guo
    • 9
  • Erin Hill
    • 7
  • Annett Janusch Roi
    • 1
  • Hajime Kojima
    • 10
  • Jin Li
    • 4
  • Chae Hyung Lim
    • 2
  • Wlamir Moura
    • 3
  • Akiyoshi Nishikawa
    • 10
  • HyeKyung Park
    • 2
  • Shuangqing Peng
    • 9
  • Octavio Presgrave
    • 3
  • Tim Singer
    • 11
  • Soo Jung Sohn
    • 2
  • Carl Westmoreland
    • 4
  • Maurice Whelan
    • 1
  • Xingfen Yang
    • 12
  • Ying Yang
    • 12
  • Valérie Zuang
    • 1
  1. 1.European Commission, Joint Research Centre (JRC)IspraItaly
  2. 2.Toxicological Evaluation and Research DepartmentKorean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety EvaluationCheongju-siSouth Korea
  3. 3.Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS)Rio de JaneiroBrazil
  4. 4.Unilever Safety and Environmental Assurance Centre, Colworth Science Park, SharnbrookBedfordshireUK
  5. 5.Division of the National Toxicology ProgramNational Institute of Environmental Health SciencesResearch Triangle ParkUSA
  6. 6.Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)WashingtonUSA
  7. 7.Institute for In Vitro Sciences, Inc.GaithersburgUSA
  8. 8.Services and Consultation on Alternative Methods (SeCAM)MagliasoSwitzerland
  9. 9.Evaluation and Research Centre for Toxicology, Institute of Disease Control and Prevention, Academy of Military Medical SciencesBeijingChina
  10. 10.Japanasese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health SciencesTokyoJapan
  11. 11.Environmental Health Science and Research Bureau, Health CanadaOttawaCanada
  12. 12.Guangdong Province Centre for Disease Control and PreventionGuangzhouChina

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