The International Cooperation on Alternative Test Methods, ICATM, is an international cooperation that includes governmental organisations from:
- the EU (the European Union Reference Laboratory for Alternatives to Animal Testing, EURL ECVAM)
- US (the Interagency Coordinating Committee on the Validation of Alternative Methods, ICCVAM)
- Japan (the Japanese Centre for the Validation of Alternative Methods, JaCVAM)
- Canada (Health Canada)
- South Korea (the Korean Centre for the Validation of Alternative Methods, KoCVAM)
- Brazil (the Brazilian Centre for the Validation of Alternative Methods, BraCVAM)
- China (currently, the Chinese Food and Drug Administration, CFDA, and the Guangdong Center for Disease Control and Prevention); and more recently
- The United Kingdom (UK Health Security Agency)
ICATM partners are working together to promote enhanced international cooperation and coordination on the scientific development, validation and regulatory use of alternative approaches.
A Memorandum of Cooperation (MoC) was signed in 2009 by four of these agencies which formalised the basis of cooperation between them in three critical areas relating to alternatives to animal testing: validation studies, independent peer review of the validation of test methods and the development of formal test method recommendations on alternative testing methods.
While collaborations have existed between these organisations for many years, prior to the signing of the MoC all interactions were largely on an ad hoc informal basis.
Background
At the first meeting of the International Cooperation on Cosmetics Regulation (ICCR), an international group of cosmetics regulatory authorities consisting of the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), the US Food and Drug Administration (FDA), the Ministry of Health Labour and Welfare of Japan (MHLW), Health Canada and, since 2014, the Brazilian Health Regulatory Agency (ANVISA), in September 2007, the ICCR recognised the importance of reducing, refining and replacing animals used in toxicity testing.
The group also recommended that collaboration and communication in the design, execution, and peer review of validation studies for scientific alternatives to animal testing be further strengthened.
In response to this, institutes dealing with validation in Europe (EURL ECVAM), the US (ICCVAM and NICEATM), Japan (JaCVAM) and Canada (Health Canada) developed a framework to ensure that a collaborative approach was adopted in future studies and validation work. Furthermore, it was noted that the framework should be supported by scientific experts from regulatory bodies.
On 29 April 2009, representative from the four agencies signed a memorandum of cooperation (MOC) that finally established ICATM.
An updated MOC including the Korean Center for the Validation of Alternative Methods (KoCVAM) to the ICATM agreement was signed 8 March 2011.
Goals and Purposes
The goals of this framework are:
- To establish international cooperation in the critical areas of validation studies, independent peer review, and development of harmonized recommendations to ensure that alternative methods/strategies are more readily accepted worldwide
- To establish international cooperation necessary to ensure that new alternative test methods/strategies adopted for regulatory use will provide equivalent or improved protection for people, animals, and the environment, while replacing, reducing or refining (causing less pain and distress) animal use whenever scientifically feasible
The purpose of the framework is to promote consistent and enhanced voluntary international cooperation, collaboration, and communication among national validation organizations in order to:
- Ensure the optimal design and conduct of validation studies that will support national and international regulatory decisions on the usefulness and limitations of alternative methods proposed for regulatory testing
- Ensure high quality independent scientific peer reviews of alternative test methods, and consistency in transparency and stakeholder involvement
- Enhance the likelihood of harmonized recommendations by validation organizations on the usefulness and limitations of alternative test methods for regulatory testing purposes
- Achieve greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources
- Support the timely international adoption of alternative methods
The framework addresses three critical areas of cooperation: validation studies, independent peer review of the validation of test methods, and the development of formal test method recommendations on alternative testing methods.
In 2015, ICATM has been enlarged to also include the Brazilian Centre for the Validation of Alternative Methods and China, currently represented by the Chinese Food and Drug Administration and the Guangdong Center for Disease Control and Prevention.
Resources
The ICCVAM Authorisation Act of 2000 charges ICCVAM with facilitating appropriate international harmonisation of toxicological test protocols that encourage the reduction, refinement, or replacement of animal test methods. This is accomplished via ICCVAM's interactions with international validation organisations such as EURL ECVAM and JaCVAM.