West Coast Lunchtime Legal Briefing Teleconference - Riding the New Wave: How to Prepare Your Life Sciences Company for Compliance and Success in the Face of China's Recent Regulatory Changes

January 16, 2014

China is one of the most important strategic markets for many life sciences and pharmaceutical companies, but navigating its rapidly changing regulatory environment does not come without challenges. The Chinese government recently announced several major changes to drug registration and contract manufacturing rules, post-market study guidelines as well as a master plan for the healthcare services industry. To successfully seize opportunities in China, companies need to ensure they stay within compliance and develop practical commercial strategies to address these new changes. 

Katherine Wang, our Shanghai-based Chief China Life Sciences Advisor, will address the following key points, and the opportunities and risks they present:

  • The China Food and Drug Administration (“CFDA”)'s proposed changes in relation to the Drug Registration Rules, the Good Clinical Practices for vaccines, the guidance for post-market clinical studies, and most importantly the possibility to transfer drug licenses through asset acquisitions;
  • The State Council's recent notice on promoting the healthcare services industry; and
  • The reforms led by other government agencies in relation to drug pricing, reimbursement and tendering.

Please contact Stephanie Carton for further information.