International Harmonization and Cooperation in the Validation of Alternative Methods.
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.
European Commission, Joint Research Centre (JRC), Ispra, Italy. joao.barroso@ec.europa.eu.
João
J
Barroso
Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea.
Il Young
IY
Ahn
Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil.
Cristiane
C
Caldeira
Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK.
Paul L
PL
Carmichael
Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, DC, USA.|Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), Washington, DC, USA.
Warren
W
Casey
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Sandra
S
Coecke
Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
Rodger
R
Curren
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Bertrand
B
Desprez
Services and Consultation on Alternative Methods (SeCAM), Magliaso, Switzerland.
Chantra
C
Eskes
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Claudius
C
Griesinger
Evaluation and Research Centre for Toxicology, Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China.
Jiabin
J
Guo
Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.
Erin
E
Hill
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Annett Janusch
AJ
Roi
Japanasese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences, Tokyo, Japan.
Hajime
H
Kojima
Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK.
Jin
J
Li
Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea.
Chae Hyung
CH
Lim
Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil.
Wlamir
W
Moura
Japanasese Center for the Validation of Alternative Methods (JaCVAM), National Institute of Health Sciences, Tokyo, Japan.
Akiyoshi
A
Nishikawa
Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea.
HyeKyung
H
Park
Evaluation and Research Centre for Toxicology, Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China.
Shuangqing
S
Peng
Brazilian Center for Validation of Alternative Methods (BraCVAM) and National Institute of Quality Control in Health (INCQS), Rio de Janeiro, Brazil.
Octavio
O
Presgrave
Environmental Health Science and Research Bureau, Health Canada, Ottawa, Canada.
Tim
T
Singer
Toxicological Evaluation and Research Department, Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation, Cheongju-si, South Korea.
Soo Jung
SJ
Sohn
Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire, UK.
Carl
C
Westmoreland
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Maurice
M
Whelan
Guangdong Province Centre for Disease Control and Prevention, Guangzhou, China.
Xingfen
X
Yang
Guangdong Province Centre for Disease Control and Prevention, Guangzhou, China.
Ying
Y
Yang
European Commission, Joint Research Centre (JRC), Ispra, Italy.
Valérie
V
Zuang
D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D006801:Humans; D007391:International Cooperation; D014116:Toxicology / Q000379:methods; D054928:Validation Studies as Topic
Alternative methods; BraCVAM; CFDA; ECVAM; Harmonization; Health Canada; ICATM; ICCVAM; International cooperation; JaCVAM; KoCVAM; NICEATM; Validation