Biopharma R&D under China's Strict Human Genetic Resources Regime – Tina Wu, Haiwen & Partners

China Law Podcast

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 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.

Read the in-depth article on China's HGR regime here, featuring insights from other experienced China life sciences lawyers.

Tina Wu is a life sciences partner at Haiwen & Partners in Shanghai with more than ten years experience working on life sciences and healthcare matters, including IP licensing and regulatory approvals.

The China Law Podcast is a weekly podcast exploring China’s business and financial sectors from a legal perspective. Get in touch at [e-mail] with any feedback and ideas for future episodes.

Episode Outline

• 01:16 Reduction in R&D activities in China
• 06:12 Ambiguous data filing requirements
• 08:43 Sensitive data categories
• 10:57 Regulatory compromise for time-sensitive data
• 12:30 Provision of HGR to foreign-invested entities
• 13:41 Listing data recipients in master application
• 15:58 Approval process for HGR materials export
• 20:15 Multi-center clinical trials
• 21:06 Patent co-ownership impact on R&D
• 23:43 Negotiating IP use and transfer

Related Content

The Impact of China’s Human Genetic Resources Regime on Pharmaceutical MNCs

Businesses Navigating Data Transfer Uncertainties by Balancing Compliance Necessity, Business Costs