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.
Note: the day in the article means working day.
After 1-year trial of 30-day IND policy, the formal expedited 30-day pathway was introduced by China NMPA since September 2025. China’s expedited IND review pathways are often described in terms of faster timelines and shorter approval windows. That’s true—but it’s not the full picture.
Speed in China today is closely tied to how well a program is prepared before it reaches the regulator. Expedited pathways can move a well-positioned program forward quickly, but they do not compensate for gaps in strategy or alignment.
In our experience supporting IND submissions in China, the programs that move fastest are rarely the ones trying to accelerate late—they are the ones that were built with regulatory expectations in mind from the beginning.
Sponsors who recognize this early tend to see the greatest benefit from expedited reviews.
Expedited Pathways Reflect Clear Regulatory Priorities
Mechanism of implied IND approval within 60 days implemented from 2018 has significantly improved the efficiency of IND approvals through China’s Center for Drug Evaluation (CDE). Now, the expedited IND review pathway further reflects clear regulatory priorities.
It is applied to category 1 innovative product and should meet one of the following criteria at least as listed below:
- Key innovative drugs with significant clinical value that are supported by the national full-chain support policy system for innovative drug development.
- Eligible pediatric innovative drugs, rare disease innovative drugs, and traditional Chinese medicine innovative drug varieties published by the Center for Drug Evaluation of the NMPA.
- Global simultaneous development drugs. Phase I and II clinical trials of global simultaneous development drugs, and Phase III international multi-center clinical trials led or co-led by principal investigators from China clinical trial institutions.
This means that eligibility for expedited review is closely linked to how well a program is positioned, not just how quickly it is submitted.
We are seeing increasing focus from the CDE on how clearly sponsors articulate clinical value and development intent to address unmet medical needs in China, and how sponsors attach importance to development in China. That target product profile and development plan determine whether a program progresses smoothly through expedited review.
The Real Constraint Is Often Alignment
For many sponsors—particularly those based outside China—there is still a tendency to introduce China later in the development process. one of the assumptions is that Start-up in China is still a little longer than other countries, or China authority requires more on CMC, Non-clinical.
In practice, this approach often creates challenges. China’s regulatory timelines have been tremendously reduced and is faster now, but it is true that if early-stage clinical data is without Chinese data, which cannot relieve the concerns on safety in Chinese patients of a late-stage dose level, additional exploratory/bridging/run-in trial will be possibly needed. If these elements are not considered early, sponsors can face delays despite being eligible for expedited review.
We often work with sponsors who expect their global IND package to translate directly into China. In reality, that’s a smart practice to following NMPA’s revolution on harmonizing local regulatory requirements with global/ICH guidelines.
The sponsors who move efficiently are those who plan for China from the outset—aligning strategy early so that expedited pathways can be fully leveraged to further accelerate the development.
For Biotech: Speed Is Now Expected
For biotech companies, expedited IND pathways have helped create a more level playing field. But as access to the expedited pathway still needs additional preparation, early planning and actions is becoming more critical.
What matters is how effectively to achieve this expedited speed. Leading companies are designing programs with both China and global requirements in mind, engaging with China PIs in earlier stage.
This typically involves:
- Early engagement with regulators and investigators.
- Clinical designs that meet both local and international expectations
- Operational readiness to begin execution immediately following approval
The most successful biotech companies we support are those that take a global view from the beginning. They consider how China fits into the broader development plan, rather than treating it as a separate step.
Where Sponsors Still Face Challenges
Despite the progress in China’s regulatory system, some misconceptions remain. One is that expedited review allows for lower levels of evidence or flexibility. In reality, expectations are high—particularly for innovative therapies.
Another is that qualifying for an expedited pathway ensures a smooth process. Without a well-prepared data package and a clear regulatory narrative, the expected time advantages may not be realised.
We have seen programs qualify for expedited pathways but still encounter delays because engagement with China clinical trial site came late, making the expedited pathway less valuable.
A More Practical Question
Rather than asking, “How do we access expedited IND review in China?”, it is often more useful to ask: “Is our program ready to move quickly within this system?”
This shifts the focus toward preparation—clinical positioning, regulatory/investigator alignment, and data readiness—well before submission.
Why This Is Increasingly Complex
While China’s regulatory pathways are clearer than in the past, applying them effectively still requires experience.
Sponsors need to consider:
- Whether their program is attractive to investigator, as supports from investigators is mandatory before regulatory submission in expedited pathway,
- How their program will be interpreted by the CDE
- Where local expectations may differ from global assumptions
- How to balance speed with scientific and operational rigor
These are not always straightforward decisions, particularly for companies navigating China for the first time.
In our experience, the difference between smooth and a delayed IND process often comes down to how well these factors are addressed early, rather than at the point of submission.
The Partner Question Sponsors Should Be Asking
Speed matters—more than ever. But in China, speed is not only about how quickly an IND can be reviewed. It is about how efficiently a program can move forward with all aspects/steps well linked and integrated.
The sponsors who achieve this are those who:
- Align with regulatory expectations early
- Build development plans that reflect both local and global requirements
- Execute with clarity once approval is received, which requires close cooperations among all functions involved in a trial.
That kind of speed requires coordination across strategy, designing, regulatory planning, and operations.
As China becomes more central to global drug development, many sponsors are recognising the value of working with partners who can connect these elements from the outset.
A partner who understands both the regulatory framework and how it is applied in practice.
A partner who can identify risks to timelines before they materialize.
A partner who supports not just faster progress, but more reliable progress.
In our work with sponsors across China and global programs, the difference is clear: when strategy, regulatory/EC alignment, and execution are connected early, expedited pathways deliver their full benefit.
Because the goal is not just to move quickly in China. It is to move forward with confidence—and to get it right the first time.