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.
Transactions involving Biocon/Zentiva, CrystalGenomics/PanGen, Umoja/IASO, Marinus/Tenacia, Ono/Captor and Daewoong/HitGen plus deals in brief.
Much of the biopharma and other health-related industries in China were already feeling the chill from ongoing macro-economic and other headwinds this year, which now look set to be complicated further by the added strain of social unrest over strict COVID containment policies. The combination of factors is already prompting some to take steps towards restructuring and divestments to survive.