Decoding China's Marketing Authorization Holder (MAH) System

Decoding China's Marketing Authorization Holder (MAH) System

The webinar was successfully concluded on

March 06, 2024

 

Topics Covered:

  • Introduction to the Chinese MAH System.
  • MAH Legislative History.
  • Administration Structure.
  • Overview of MAH Responsibilities.
  • Marketing Authorization Application.
  • Pharmaceutical Product Import.
  • Pharmaceutical Product Distribution.
  • Agent of Overseas MAH.
  • The Challenges & Benefits of Appointing MAH Agent in China.
  • Tips for Navigating the MAH Agent Landscape in China.
  • Q&A Session.

As a continuous practice, Freyr organizes more webinar sessions related to Regulatory aspects in Life Sciences. We presume you would like to be a part of all those sessions. If so, let us have an opportunity to inform you about our next session.

   

Patricia is a Regulatory Affairs (RA) expert with over thirty (30+) years of experience in the Japanese market. As the Head of Country for Freyr Life Sciences Japan, she leads a team of over twenty (20+) Subject Matter Experts (SMEs) who assist international clients in obtaining Regulatory approval in Japan.

   

Jane has over seventeen (17+) years of experience in new drug R&D and more than twenty (20+) years in Regulatory Affairs (RA). She possesses a deep understanding of NMPA and global regulations, including FDA, EU, and ICH. Her strong scientific background, extensive knowledge, and previous role as a CDE reviewer contribute to her comprehensive understanding and interpretation of these regulations.

Hosted By

Patricia Bader – Johnston

Representative Director & Country Head, Freyr Japan

Presented By

Jane Zhang

Sr. Director Regulatory Affairs, Freyr China