Hainan MPA Issues Trial Lecheng Real-World Data Guideline for Imported Drug & Medical Device Registration

On April 29, 2026, the Hainan Medical Products Administration (Hainan MPA) issued the "Guideline (Trial) for the Use of Clinical Real-World Data in the Lecheng Pilot Zone to Support Registration Applications for Imported Drugs and Medical Devices."

The guideline does not create a shortcut around conventional clinical evidence. What it does do is far more useful: it gives overseas drug and medical device manufacturers a defined, structured pathway for using China-based clinical experience to fill specific evidence gaps in their registration strategy. For the first time, the expectations are explicit.

That clarity is what makes this worth paying attention to, whether you are planning a first China registration, managing post-approval commitments, or assessing lifecycle opportunities for a product already on the market.

At a Glance

• Who it affects: Overseas manufacturers of imported drugs and medical devices seeking registration or post-approval activities in China
• What it does: Formalises a five-stage framework for using Lecheng-generated real-world evidence as supplementary evidence in NMPA registration applications
• Beyond registration: Real-world evidence can also support labelling changes, indication expansions, and other post-approval activities
• Best suited for: Innovative products, rare disease therapies, and products requiring additional China-specific safety, effectiveness, or performance data
• Key constraint: Real-world data generated in China generally cannot be transferred outside China without satisfying applicable cross-border data requirements

The Lecheng Pilot Zone: A Brief Background

The Boao Lecheng International Medical Tourism Pilot Zone in Hainan is the only region in China where overseas-approved drugs and medical devices that have not yet been registered with the NMPA can be used in clinical practice. That unique status, in place since 2018, makes Lecheng the natural setting for generating China-based clinical data on imported products.

The clinical real-world data pilot formally launched in 2019. Since then, several products have received NMPA marketing authorisation supported in part by real-world evidence from Lecheng, including treatments for non-small cell lung cancer, small cell lung cancer, and primary hypercholesterolaemia.

The April 2026 guideline builds on that experience by providing the most operationally detailed framework yet for how sponsors should design, conduct, and submit Lecheng real-world studies.

The Five Stages Framework: What it Means in Practice

The guideline establishes a sequential five-stage process. Understanding each stage and its practical implications for organizations, is essential before committing resources to a Lecheng study.

1. Regulatory Communication

The framework encourages sponsors to engage with the Hainan MPA through the "Real-World Research Communication Exchange" mechanism at key points during study planning and implementation.

What this means for organizations: Do not start with a study design. Start with a regulatory question. Lecheng evidence adds the most value when it is built around a defined gap in organizations registration package, e.g. a specific safety question, a Chinese population endpoint, a long-term performance outcome.

Regulatory engagement before study design finalisation is not optional; it is the mechanism for confirming that the evidence strategy is aligned with review expectations before a company invest in execution.

2. Assessment of Overseas Clinical Data

Sponsors must evaluate how existing overseas clinical trial data fits into the overall China registration strategy and where the remaining gaps lie.

Common applications for Lecheng Real-World Evidence:

• China-specific clinical use patterns and patient characteristics
• Long-term safety or device performance outcomes
• Rare disease populations with limited trial data
• Product performance in Chinese clinical settings

What this means for organizations: Most manufacturers entering China already hold data from global clinical trials, post-market surveillance programs, or approvals in other jurisdictions. The question is not whether Lecheng evidence is “better” than that data; it is whether Lecheng is the right place to generate what is still missing. Map evidence gaps first, then assess whether Lecheng addresses them.

3. Study Design and Implementation

The guideline places significant weight on scientifically rigorous study design with clearly defined objectives from the outset.

A Lecheng study intended for regulatory use must be built to a different standard than data collected for general clinical learning.

Design elements to define before implementation:

• Study population and inclusion / exclusion criteria
• Primary and secondary endpoints
• Data sources and collection methods
• Follow-up period
• Bias-control measures
• Statistical methodology

What this means for organizations: For innovative products and rare disease therapies in particular, these design decisions will determine whether the resulting evidence is suitable for regulatory review. A protocol built around a defined regulatory question, rather than general curiosity, is the difference between evidence that moves a registration forward and data that sits unused.

4. Data Management and Evidence Quality Evaluation

Regulators will assess not only the findings from a Lecheng study, but the integrity of the processes used to generate them. Sponsors must establish systems covering data collection, management, verification, analysis, and full traceability.

For multinational companies, this typically requires coordination across:

• Lecheng medical institutions and local study teams
• China regulatory affairs and quality management functions
• Global clinical operations and data management
• Vendor networks and CRO partners

What this means for organizations: Data quality is not a validation step at the end; it is a design requirement from the beginning. Build data governance infrastructure before the first patient is enrolled, not after.

5. Ethics Review and Subject Protection

Independent ethics oversight is mandatory. Research protocols must undergo ethics committee review, and sponsors must implement robust safeguards for informed consent, personal information protection, and participant welfare throughout the study's lifecycle.

The data governance dimension:

The guideline explicitly flags a critical operational consideration that affects multinational organizations: real-world data generated in China generally cannot be transferred outside China unless the applicable cross-border data requirements, under China’s Personal Information Protection Law (PIPL) and related regulations, are satisfied. This is now a fully operational regulatory regime as of 2026.

Practical implications for organizations:

• Database architecture and where data is hosted
• Headquarters and global team access to study data
• Centralized statistical analysis workflows
• Vendor selection and CRO agreements
• Informed consent documentation covering data use

Address privacy, data localization, cybersecurity, and cross-border transfer requirements during study planning. Retrofitting compliance after data collection begins is expensive, time-consuming, and may jeopardise the regulatory acceptability of the evidence.

Beyond First Registration: Post-Approval Applications

One aspect of the guideline that deserves more attention than it typically receives is its scope beyond initial registration. The framework explicitly covers the use of Lecheng real-world evidence to support:

• Labelling updates and indication expansions
• Long-term safety assessments for high-risk products
• Post-approval commitments made at the time of registration

For manufacturers who have already entered the China market, this means Lecheng is not only a registration tool. It is a lifecycle management resource. Products that received conditional approval with post-market obligations, or that are candidates for label expansion, should be evaluated against this framework as part of their China lifecycle strategy.

Final Thoughts

The Hainan MPA’s "Guideline (Trial) for the Use of Clinical Real-World Data in the Lecheng Pilot Zone to Support Registration Applications for Imported Drugs and Medical Devices" does not make rel-world evidence easier to use. Its strategic significance is that expectations are now explicit and explicit expectations are something that disciplined sponsors can plan against.

The pathway will reward those who treat it as a regulatory program, not a data-gathering exercise: with clear objectives, early regulator engagement, rigorous study design, ethics compliance from the outset, and data governance that is built for the China environment.

As Lecheng real-world evidence becomes a more established part of China regulatory landscape, the organisations that built these capabilities now will be better positioned across registration, post-approval, and market access. The guideline has set the terms. The question is who is ready to meet them.

Cisema helps global drug and medical device manufacturers develop Lecheng evidence programs that support registration, lifecycle, and market access objectives in China – from regulatory strategy and early engagement through to study execution and data compliance.

Further Information

• Explore Cisema’s pharmaceutical consulting services
• Discover Cisema’s medical device services for China

Reference

• Notice of the Hainan Provincial Medical Products Administration on Issuing the "Guidelines for the Use of Clinical Real-World Data from the Lecheng Pilot Zone to Support Registration Applications for Imported Drugs and Medical Devices (Trial)"