,A Regulatory Guide to DMF Submissions in China: APIs, Excipients & Packaging Materials Explained
The webinar was successfully concluded on
31st March 2026
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Thank you to everyone who joined Freyr’s webinar, “Regulatory Pathways for APIs, Excipients, and Packaging Materials in China.”
We truly appreciate your participation and engagement during the session.
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In this session, our Regulatory experts discussed how APIs, excipients, and pharmaceutical packaging materials are reviewed under China’s Regulatory framework.
The webinar focused on DMF registration pathways, MAA integration, documentation expectations, and lifecycle management, highlighting practical considerations for both local and overseas manufacturers.
Key Topics Covered
- Overview of China’s Regulatory landscape for APIs, excipients, and packaging materials
- Scope and submission pathways for API registry
- Classification and documentation expectations for pharmaceutical excipients
- Scope and classification of packaging materials and container closure systems
- Submission considerations for excipients and packaging materials registries
- Key takeaways and practical tips for navigating DMF submissions in China
Angela M. Gómez is a seasoned strategist working across Regulatory fields, currently focused on the pharmaceutical sector. She blends strategic communications and brand positioning with Regulatory insight, shaping clear, value-driven narratives that reinforce quality standards while strengthening long-term market presence across Latin America.
Jane Zhang brings 17+ years of experience in new drug R&D and 20+ years in Regulatory Affairs, with deep expertise across NMPA, FDA, EU, and ICH frameworks. Her prior role as a CDE reviewer enables her to translate regulatory requirements into practical submission strategies that align with authority expectations.
Host
Angela M Gómez
Communication Specialist, Freyr Latam
Speakers
Jane Zhang
Sr. Director – Regulatory Affairs, Freyr China