Decoding China's Marketing Authorization Holder (MAH) System
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