##  [A Regulatory Guide to DMF Submissions in China: APIs, Excipients & Packaging Materials Explained](/index%2ephp/webinars/a-regulatory-guide-to-dmf-submissions-in-china-apis-excipients-packaging-materials-explained) 

<a>Medicinal Products</a>



<a>Past Webinar</a>



## **A Regulatory Guide to DMF Submissions in China: APIs, Excipients &amp; Packaging Materials**

**The webinar was successfully concluded on**

  **March 31, 2026**

[Download Webinar](javascript:void(0))







**A Regulatory Guide to DMF Submissions in China: APIs, Excipients &amp; Packaging Materials Explained**

The webinar was successfully concluded on  
**31st March 2026**

**Download the Webinar Recording**

### Thank You for Joining Us

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.

### Missed the Webinar or Want a Recap?

You can now access the **on-demand recording** to revisit the expert insights shared during the session and gain clarity on China’s evolving Regulatory requirements.

### Watch the On-Demand Webinar

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&amp;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