China's Lecheng Pilot Zone publishes new guidance for real-world evidence in drug and device approvals

China's Hainan Medical Products Administration has published new guidance governing the use of real-world data (RWD) generated in the Lecheng Pilot Zone to support drug and medical device registration applications. The framework formalizes expectations around study design, data quality, evidence assessment, and regulatory engagement.

The Baseline

• Hainan MPA has issued new guidance outlining how RWD generated in the Lecheng Pilot Zone can be used to support regulatory submissions for drugs and medical devices in China.
• The guidance introduces detailed requirements covering study design, data governance, evidence quality, ethics, and the assessment of overseas clinical trial data.
• Manufacturers are encouraged to engage with regulators throughout the research process through protocol-specific, consultation, and pre-submission meetings aimed at improving the quality and regulatory utility of real-world evidence (RWE).

The Hainan Medical Products Administration (Hainan MPA) has published a new guideline intended to standardize the use of clinical RWD generated in the Boao Lecheng International Medical Tourism Pilot Zone (Lecheng Pilot Zone) to support registration applications for drugs and medical devices developed outside China.

Issued in late April 2026, 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”, originally published in Chinese, provides a comprehensive framework covering study design, data quality, evidence assessment, ethics, and regulatory interactions.

China's Lecheng Pilot Zone occupies a unique position within the country's regulatory landscape. Established in Hainan Province in 2013, it is the only jurisdiction in China authorized to import and use certain innovative drugs and medical devices approved overseas before they receive full approval from the National Medical Products Administration (NMPA). Since the launch of the NMPA-Hainan RWD pilot program in 2019, manufacturers have been able to generate RWE from the use of these products within Lecheng and submit it as part of registration applications, creating an alternative pathway to support regulatory decision-making and accelerate patient access to innovative therapies.

As of January 2026, 47 licensed medical products had entered the program, with the resulting evidence contributing to regulatory approvals for 22 products, including 16 medical devices and six drugs.

According to Hainan MPA, the objective of the new guidance is to improve the quality of RWE, increase registration efficiency, and accelerate the availability of innovative medical products in China.

The guideline outlines several scenarios in which Lecheng-generated RWE may support regulatory decision-making. These include serving as supplementary evidence alongside traditional clinical trials, supporting products for rare diseases and life-threatening conditions where conventional trial data may be limited, evaluating the long-term safety and effectiveness of high-risk products, and supporting label expansions or modifications for already marketed products.

The guidance also stipulates the introduction of a structured communication framework between applicants and regulators. Manufacturers are encouraged to engage with authorities at key stages of the research process through protocol-specific meetings, consultation meetings, and pre-submission meetings. These interactions are intended to discuss study design, registration strategy, technical challenges, and the integration of Lecheng-generated evidence with other clinical data sources.

The document also establishes a formal process for assessing the value of overseas clinical trial data. Applicants are required to conduct a self-assessment covering factors such as trial quality, ethical compliance, endpoint selection, data completeness, and the relevance of study populations to Chinese patients. Particular attention is given to ethnic differences and the extent to which treatment effects observed in international studies can be extrapolated to Chinese populations.

Beyond study design considerations, the guidance places significant emphasis on data governance and quality assurance. Applicants are expected to develop detailed data management and governance plans, document data cleaning and quality-control procedures, assess the fitness-for-purpose of RWD sources, and adopt recognized standards such as CDISC where appropriate. Statistical analysis plans must be predefined, with investigators expected to address potential sources of bias, confounding, and missing data through appropriate analytical methods and sensitivity analyses.

The guideline also introduces a structured framework for evaluating RWE across three domains: relevance and applicability, reliability and integrity, and evidence strength. Applicants must demonstrate that study populations, comparators, endpoints, and analytical methods are appropriate for the regulatory questions being addressed and that the resulting evidence forms part of a coherent overall evidence package.