Data Protection in China: 17 Years after China's WTO Accession

Abstract

China introduced dual data protection (both undisclosed information and six-year data exclusivity) for pharmaceutical products from its accession to the WTO. From 2017, a new series of policies proposed up to 12 years of data exclusivity for biologics. The drug negotiation mechanism in China should be considered in evaluating the impacts of these policies on enhanced data protection Show more