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

China Law Podcast

China Law Podcast에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 China Law Podcast 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

3+ y ago 25:30

MP3•에피소드 홈

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 vchow@alm.com 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