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Regulatory exclusivity protection for undisclosed test data in China: an innovative approach to implementing the TRIPS Agreement

Zhiwen Liang

Keywords: access to medicine; China-US trade disputes; regulatory exclusivities; undisclosed test data; TRIPS Agreement

Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.

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