Market Entry for Food Products and Supplements in Latin America: Navigating Regulatory Challenges

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Upcoming Webinar

A Regulatory Guide to DMF Submissions in China: APIs, Excipients & Packaging Materials

March 31, 2026

40 Minutes

Join the Webinar as per Your Time Zone

For Americas & European Region

11:00 AM EDT | 10:00 AM CDT | 8:00 AM PDT | 4:00 PM GMT

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For Rest of the World 

11:30 AM IST

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We’re glad to see your interest in Freyr’s Webinar Series. Join us for an in-depth webinar, “A Regulatory Guide to DMF Submissions in China: APIs, Excipients & Packaging Materials,” scheduled on March 31, 2026.

This live session is designed for global pharmaceutical and life sciences professionals navigating the complex and evolving China DMF landscape.

What is it all about?

China’s Drug Master File (DMF) framework is no longer a procedural requirement; it has become a decisive factor in drug approval timelines. APIs, excipients, and packaging materials must now meet increasingly stringent and interpretation-driven NMPA expectations.

Despite Regulatory guidance, many DMF submissions continue to face unexpected delays, repeated authority queries, and avoidable rework. The reasons are rarely obvious: unclear registry scope, misaligned classification logic, and documentation strategies that fail to reflect how NMPA reviewers assess submissions in practice.

If you are responsible for preparing, reviewing, or managing China DMFs, this webinar will give you the clarity that written guidelines don’t provide.

   

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

Why You Should Attend

This session goes beyond theory to focus on real-world Regulatory outcomes. You will gain insight into how early DMF decisions impact downstream approvals and where most submissions fail before reaching technical review.

The webinar concludes with a “Ask the Expert” Q&A, allowing you to raise your specific DMF challenges directly with the expert.

About the Session

The webinar will be hosted by Angela M Gómez and presented by Jane Zhang.

Delivered by a seasoned Regulatory expert, this session brings a regulator-level perspective on DMF scope, documentation depth, and submission strategy, drawn from hands-on experience with China filings and authority interactions.

Key Topics to Be Covered

  • How China’s DMF framework works in practice, not just on paper
  • Defining correct registry scope for APIs, excipients, and packaging materials
  • Where DMF submissions most commonly fall short
  • Practical strategies to minimize NMPA queries and review cycles

We understand the value of your time. This focused, expert-led session is designed to deliver clear, actionable insights you can apply immediately.

Reserve your spot today