Podcast #33: Foreign-Sponsored Clinical Trials Under China's Human Genetic Resources Regime – Tina Wu, Haiwen & Partners

May 14, 2021 | BY

Vincent Chow

China's HGR regime still delays foreign-sponsored clinical research despite recent streamlining of review process

Human genetic resources such as organs, cells, and tissue are crucial to the clinical trials that pharmaceutical multinationals conduct in order to get their products registered for use in China, whether it be a new drug or medical device. China's HGR regime was recently elevated to the level of a national statute for the first time when the PRC Biosecurity Law (中华人民共和国生物安全法) came into effect in April. Tina Wu discusses how China's HGR regulator has enforced strict HGR rules since 2019, including intellectual property co-ownership between foreign and Chinese parties and HGR exports.

For the full episode, click here to listen on Apple Podcasts and here for Spotify. Read the in-depth article on China's HGR regime here, featuring insights from other experienced China life sciences lawyers.

This premium content is reserved for
China Law & Practice Subscribers.

  • A database of over 3,000 essential documents including key PRC legislation translated into English
  • A choice of newsletters to alert you to changes affecting your business including sector specific updates
  • Premium access to the mobile optimized site for timely analysis that guides you through China's ever-changing business environment
For enterprise-wide or corporate enquiries, please contact our experienced Sales Professionals at +44 (0)203 868 7546 or [email protected]