The delegation also included representatives from several AmCham China member companies. This visit followed a policy exchange meeting held in June 2023 at the FDA’s China office. The 2024 Policy Exchange Meeting focused on the latest regulatory policies in the healthcare industry in both the United States and China.
Ma welcomed the FDA delegation and provided an in-depth introduction to AmCham China. Her presentation included an overview of the Chamber’s Healthcare Industry Group and its efforts to foster government-business engagement in the healthcare regulatory sector. Dr. Weiner shared insights into the FDA’s global strategic planning efforts, emphasizing the challenges faced by foreign-invested enterprises in China’s healthcare sector. These include navigating diverse regulatory requirements across different jurisdictions and identifying suitable partners to support either international expansion for local companies or localization efforts for foreign enterprises in China.
During the subsequent open discussion, AmCham China member companies and FDA representatives exchanged views on several key topics. The dialogue covered optimizing localization policies, including cross-border manufacturing, government-centralized procurement standards, and the definition of “Made in China.” Additionally, they discussed clinical trials and data management issues, including updates to data transmission regulations, privacy protection, and the feasibility of leveraging real-world data to support clinical trials.
The discussions were both comprehensive and productive. AmCham China and the FDA reaffirmed their commitment to existing collaboration mechanisms and agreed to strengthen communication further. Together, they aim to assist foreign-invested enterprises in overcoming challenges related to pharmaceutical and medical regulatory affairs in China.
