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Implementing drug data exclusivity in China: a comparative analysis with global practices
1Center for Drug Evaluation, National Medical Products Administration, China.
Abstract:
This article provides a comprehensive overview and comparative analysis of China's forthcoming drug data exclusivity system, contextualizing it within global frameworks. It presents the current data exclusivity regimes of the United States, Canada, the European Union and Japan, and also elaborates on the upcoming policies that China intends to implement, including the exclusivity periods, protection mechanisms and protection objective, etc. The analysis evaluates China's framework against TRIPS Agreement standards, noting its alignment in protection scope and methods. Potential challenges are discussed, including impacts on generic drug accessibility, is the AI-generated data protected, and risks of policy overlap, etc. The article concludes that China's regime reflects a strategic effort to balance international intellectual property norms with domestic industrial reality.
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