Japan National Validation Center: JaCVAM

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Japan: Programs & Policies

Japan: JaCVAM – National Validation Center

Last updated: April 27, 2011

The Japanese Center for the Validation of Alternative Methods (JaCVAM) is located in the office of New Testing Method Assessment, Division of Pharmacology, Biological Safety Research Center (BSRC), National Institute of Health Sciences (NIHS) in Tokyo. Dr. Hajime Kojima is the Director of JaCVAM.

JaCVAM was established in 2005, and is charged with the following key activities (Kojima, 2008): 1) to facilitate the 3Rs (Reduction, Refinement, and Replacement) in animal testing for regulatory purposes, prioritizing Reduction and Replacement; and 2) to ensure new methods originated in Japan are validated, peer reviewed, accepted by regulatory agencies, and made internationally compatible. The purpose and responsibilities of JaCVAM are similar to those of its US and EU counterparts, NICEATM-ICCVAM and ECVAM, respectively.

JaCVAM’s Policy and Mission are defined as follows:

  • to promote the 3Rs in animal experiments for the evaluation of chemical substance safety in Japan, and
  • to establish guidelines for new alternative experimental methods through international collaboration

To facilitate the conduct of these activities, JaCVAM cooperates with other organizations such as the Japanese Society for Alternatives to Animal Experiments (JSAAE) and the Japanese Cosmetic Industry Association (JCIA).

JaCVAM and the JSAAE also collaborate on national and international symposia focusing on alternative test methods. The NIHS, JaCVAM, and the JSAAE coordinated and hosted the 6th World Congress on Alternatives and Animal Use in the Life Sciences which was held in Tokyo in August 2007. JaCVAM also participates in JSAAE annual meetings, such as the 23rd Annual Meeting held in December 2010.

The English version of the JaCVAM website, launched in August 2009, provides stakeholders outside of Japan with easier access to their activities. The site provides details on the organization of JaCVAM, and describes the committees and groups that participate in advising JaCVAM and in the review of alternative methods in Japan.

The Update on JaCVAM page provides a table that describes the validation/peer review/regulatory acceptance status of different alternative test methods that are undergoing, or have undergone, evaluation by JaCVAM. The types of toxicity test methods that have or are undergoing validation studies or review by JaCVAM include alternative methods for skin irritation, skin corrosion, skin absorption, skin sensitization, phototoxicity, eye irritation, acute oral toxicity, genotoxicity, endocrine disruptor screening, carcinogenicity screening, and pyrogenicity testing.

The JaCVAM Regulatory Acceptance Board issues statements on the validity of test methods reviewed by JaCVAM peer review panels. Statements endorsing the validity of following methods have been made: the Vitrolife-SkinTM 3-dimensional cultured skin model for skin corrosivity testing, the LLNA DA for skin sensitization testing, the bovine corneal opacity (BCOP) and permeability test for severe ocular irritants, the isolated chicken eye test (ICE) for severe ocular irritants, the EpiSkin in vitro skin irritation test, and the LLNA BrdU-ELISA for skin sensitization.

Articles and presentations are listed under Academic Activities; this section elaborates on the wide range of scientific studies and collaborations in which JaCVAM scientists have been involved.

JaCVAM also participates in international activities intended to facilitate the validation, acceptance, and/or harmonization of alternative test methods, including those of the OECD, ECVAM, ICCVAM, and International Cooperation on Alternative Test Methods (ICATM). In 2010, Dr. Nishijima signed as General Director of NIHS in the ICATM agreement between Japan, the US, the EU, Canada and Korea intended to enhance international cooperation on the validation and evaluation of new toxicity test methods.

Dr. Kojima and the JSAAE have also provided important leadership in the establishment of alternative methods in other Asian countries. They have collaborated with Korea, which announced in November 2009 the launch of the Korean Center for the Validation of Alternative Methods (KoCVAM).