For more than a decade, China has been the world's leading supplier of active pharmaceutical ingredients. Today, it is not only the world's second largest pharmaceutical market, behind only the United States, but it also produces about four percent of the world's new pharmaceutical products....

This study investigates how enhanced regulation can promote innovation, focusing on the impacts of a significant regulatory reform in China's pharmaceutical sector implemented in 2015. Inspired by regulatory practices in the U.S., the reform aimed to address application backlogs and reduce...

The patent laws of many countries have ''research exemption'' provisions that exempt certain research-related uses of proprietary materials from patent infringement. By limiting the rights of existing patent holders, such rules are meant to facilitate follow-on innovation and benefit latecomer...

This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a...