Thoughts on the Construction of Pediatric Exclusivity Policy in China

Abstract

Objective To study the 6-month patent exclusivity rule in the US and provide reference for designing pediatric exclusivity policy in China. Methods In this paper, summarize the development history and status of pediatric exclusivity in the US was summarized to analyze its effect for pediatric drugs research and development incentive and information improvement. Then, we can learn from its experience to construct pediatric exclusivity policy in China. Results and Conclusion Pediatric exclusivity policy in the US has obvious incentive effects, but the scope is limited to patented or other data protected drugs. Based on the successful experience of the United States, we can fully evaluate the impact of patents and other data protection policies on the exclusive marketing rights. In addition, we should conduct in-depth study on the applicable objects, authorization scope, protection mode and time limit of the pediatric exclusivity so that we can introduce supporting measures for China’s pediatric exclusivity as soon as possible.

Keywords

pediatric drug / data protection / market exclusivity

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