Regional Organizations for Harmonization of Regulations
In addition to the international harmonization efforts of the ICH, there are a number of regional organizations working to harmonize drug regulations. These efforts include: ASEAN (Association of South-East Asian Nations), CAN (Andean Community), CADREAC (The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries), the European Union, Gulf Cooperation Council (GCC), MERCOSUR (Southern Common Market), the Pan American Network on Drug Regulatory Harmonization (PANDRH), and the Southern African Development Community (SADC).
The major goal for many of these organizations is to improve access within their regions to safe medicines by harmonization of drug quality, safety, and efficacy standards and guidelines. These harmonization efforts have the potential to reduce the numbers of animals used for drug registration in these countries by resulting in elimination of safety testing procedures that are outdated, duplicative, and/or of limited usefulness, or the introduction of new non-animal methods.
Japanese National Institute of Health Sciences (NIHS)
The Japanese National Institute of Health Sciences (NIHS) is the national agency that conducts the testing and research needed to ensure the quality, safety, and efficacy of pharmaceutical and medical devices, foods, and chemicals for the Japanese people. The NIHS also participates in international activities, such as the collaborations with the WHO, the OECD, and the ICH.
The Japanese Center for the Validation of Alternative Methods (JaCVAM) is part of the NIHS. JaCVAM has conducted validation studies for alternative test methods and participates in the international validation efforts of European Centre for the Validation of Alternative Methods and Interagency Coordinating Committee on the Validation of Alternative Methods. NIHS staff affiliated with JaCVAM and the Japanese Society of Alternatives to Animal Experiments (JSAAE) were major sponsors and organizers of the August 2007 6th World Congress on Alternatives and Animals in the Life Sciences.
ICAPO & ICAPI
The International Council for Animal Protection in OECD Programmes (ICAPO) is a non-governmental organization established in 2002 to provide formal representation of animal protection interests in certain activities within the test guidelines programme of the OECD. "ICAPO is officially recognized by the OECD as an 'expert group' and thereby participates in key OECD meetings." Goals of ICAPO include promoting greater use of alternative methods and reductions in animal use in OECD testing programs, and incorporation of more alternative methods in OECD Test Guidelines.
ICAPO member organizations include the following:
- Animal Alliance of Canada
- British Union for the Abolition of Vivisection
- Doris Day Animal League
- Eurogroup for Animals
- European Coalition to End Animal Experiments
- The Humane Society of the United States
- Japan Anti-Vivisection Association
- People for the Ethical Treatment of Animals
- Physicians Committee for Responsible Medicine
The International Council on Animal Protection in ICH (ICAPI) comprises the same animal protection organizations as ICAPO, and was established to provide input on the incorporation of alternative methods into ICH programs and guidelines. ICAPI received "Interested Party" status with the European Medicines Agency (EMEA) in 2005. Activities have included meetings with organization officials and submission of concept papers to promote the adoption of validated alternative methods
International Council of Chemical Associations (ICCA)
The International Council of Chemical Associations (ICCA) is an international alliance of chemical companies representing over 75 percent of the chemical manufacturing operations. ICCA promotes and coordinates (i) voluntary chemical industry initiatives such as Responsible Care and (ii) communications between the chemical industry and international organizations involved with health, environmental, and trade issues.
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