Perspectives of the Development Strategies for a Future Toxicity Testing System in China: Challenges and Opportunities

For many years, toxicological studies in animals have been used to determine potential health risks in humans. There are increasing concerns that such an approach is costly in terms of the resources required to conduct the tests and may not provide sufficient information to adequately protect human health. The growing backlog of chemicals yet to be assessed for potential human health hazards has led to calls to develop high throughput, low-cost testing strategies using end points that are more relevant to humans (Hartung 2009). In 2007, the U.S. National Research Council (NRC) released a landmark report, Toxicity Testing in the 21st Century: A Vision and a Strategy (NRC 2007), that envisioned a revolutionary change in the future of toxicity testing. A similar approach has been described by AXLR8 (AXLR8 Consortium 2011), a project funded under the European Commission's Seventh Framework Programme. These documents from the NRC and AXLR8 Consortium articulate the current effort to increase efficiency and decrease animal use in toxicity testing by transitioning from in vivo tests with qualitative end points to in vitro assays based on human cells or cell lines that use robotic high through-put screening and mechanistic quantitative parameters. Implementation of such a strategy could foster a new paradigm that enhances human relevance of toxicological studies, thereby allowing regulatory decisions to be based on human rather than animal biology have called on the toxicological community to work together to promote a more international acceptance of this approach. Given the deficiencies of the current toxicological testing approach, it seems logical to develop a global consensus on the new paradigm. There are many challenges to such harmoniza tion because each nation's particular circumstances—ranging from technical limitations to legislative and economic issues—could hinder the implementation and acceptance of the transition (Hartung 2009). In China, steps have yet to be taken to fully explore and embrace the move to alternative approaches to toxicity testing. Although ancient China, dating back to 5,000 years ago, is one of the earliest cultures to have an understanding about toxic chemicals, the toxicological testing paradigm in China was established long after the scientific discipline of toxicology began to evolve in other parts of the world. Because of this, a gap exists between China's current approach to toxicological testing and the cutting edge of the field. This difference is best observed in the methods currently used in China to assess toxicological risks of drugs and …