By: Charley Sha, Senior Regulatory Affairs Director
Graduated from Beijing University of Chinese Medicine with master degree. More than 15 years regulatory affairs experience in multinational pharmaceutical company and CRO; Extensive experience in drug clinical trial applications, marketing applications, regulatory maintenance during clinical development and post-marketing stage, HGRAC-related affairs; Experienced in medical device marketing applications and regulatory intelligence; Previously worked as RA at Novo Nordisk, Ferring, Janssen and Pharmanet.
Since Mar 2026, China NMPA further enlarged the scope of submission via eCTD v3.2.2, updated the eCTD technical standard to version 1.1. China’s move to accept eCTD submissions is a practical step forward, but its impact will be broader than many expect.
It doesn’t just change how submissions are formatted. It improves how they are built, maintained, and reviewed over time.
For sponsors, this creates a real opportunity: those who adapt early will find that working with regulators in China becomes more predictable, more consistent, and easier to manage across the life of a product, especially for sponsors who is running or planning to run global trials.
A more structured system—and a more reliable one
In less structured environments, teams often rely on workarounds—managing multiple versions, fixing inconsistencies late, and adapting documents as needed.
eCTD brings structure to that process.
Everything is organized, traceable, and connected. Once in place, it creates a clearer foundation for both sponsors and regulators to work from.
That structure doesn’t slow things down—it makes interactions more straightforward, especially as submissions evolve.
What we’re seeing is that well-structured submissions are leading to more efficient review cycles, particularly when submitting an amendment to authority. And we can also expect all the lifecycle activities to be under eCTD soon, such as responding to regulatory questions during an application reviewing.
For China-based companies, this supports global growth
For domestic biotech and pharma companies, this shift aligns China more closely with international regulatory standards. That matters.
It makes it easier to:
- Build submissions from IND to NDA/BLA that can support multiple regions
- Develop internal processes that scale with growth
- Prepare for global development earlier in the lifecycle
While it requires more upfront coordination, it also reduces rework later—particularly for companies planning to expand beyond China.
We’re seeing more China-based companies use eCTD as a foundation for global submissions, rather than treating regions separately.
For global sponsors, China becomes easier to integrate
For companies running multi-region programs, this is a meaningful step.
eCTD makes it more practical to:
- Use a shared core dossier across markets
- Align submission planning across regions
- Reduce duplication of effort
At the same time, success still depends on understanding how China operates in practice.
Format alignment helps—but local regulatory expectations still matter, particularly in how data is presented and discussed. Such as the regional modules may need to prepared according to local authority.
When global and China teams align early, we see much smoother submissions—with fewer revisions needed during review.
The real advantage comes over time
The biggest benefit of eCTD is not the initial submission—it’s what happens after.
Each update, response, and variation builds on a structured foundation. That makes it easier to:
- Track changes
- Maintain consistency
- Respond more efficiently to regulators
For sponsors managing multiple submissions or ongoing changes, this creates a more stable and predictable process.
Where preparation makes the difference
This transition does require a shift in approach.
Sponsors who see the most benefit are:
- Planning document structure earlier
- Aligning global and local teams from the outset
- Treating publishing as part of the process—not just the final step
These are practical changes, but they have a noticeable impact on how smoothly submissions progress.
What we’re seeing at Novotech
Across both China-based and global sponsors, one pattern stands out.
When eCTD is built into the process early, submissions tend to move forward with fewer complications—and teams spend less time revisiting or restructuring content later.
In our experience, early alignment between global and China teams is the single biggest factor in avoiding delays and keeping submissions on track.
This is where local experience matters—not just in understanding requirements, but in knowing how to apply them in a way that works in practice.
Final thought
China’s move to eCTD is a step toward a more consistent and predictable regulatory environment.
It rewards preparation, clarity, and alignment—and makes it easier for well-prepared sponsors to move forward with confidence.
For companies investing in China, that’s a positive shift.
And for those who get it right early, it creates a smoother path—not just for submission, but for everything that follows.