China Regulatory Express: Patent Linkage, Data Protection, Bio Five-Year Plan
Important Changes Coming
Important changes are coming to China's Drug Administration Law as the government aims to address through several revisions a number of key issues since the law’s original enactment in 2019.
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New draft rules outline market exclusivity provisions for orphan and pediatric drug development, along with mutual recognition of ethics reviews, in developments being seen as positive for the industry.
While many pharma firms in China choose to partner with US companies, Jiangsu Hengrui is relying on itself to go global. The Chinese pharma giant is betting on its newly established US subsidiary Luzsana in a major move to make its wide-ranging products more available, accessible and affordable to patients in the US and the rest of the world.
Home-grown Chinese mRNA COVID-19 vaccines are more effective than domestic inactivated virus-based shots, new trial results show.