Hainan Issued a Trial Guideline on Lecheng Real-World Data for Product Registration in 2026

The Hainan Provincial Medical Products Administration (Hainan MPA) has issued a trial guideline on the use of real-world data (RWD) generated in the Boao Lecheng International Medical Tourism Pilot Zone to support registration of imported drugs and medical devices. Secondary reporting gives the issue date as 29 April 2026; one report is dated June 2026, but the April date is the better supported. The guideline aims to standardise how clinical RWD collected in the zone is used in applications to the National Medical Products Administration (NMPA).

Commentators describe the guideline as the most operationally detailed framework so far for designing and submitting Lecheng real-world studies. One secondary source reports that it sets out a five-stage framework for using Lecheng-generated real-world evidence as supplementary evidence in NMPA registration applications. The full Chinese text was not available for review for this brief, so readers should consult the original document from the Hainan MPA for the detailed requirements.

The Boao Lecheng pilot zone is the only region in China where drugs and medical devices approved overseas but not yet registered with the NMPA can be used in clinical practice. Once a product is approved for use in the zone, and with the consent of the Hainan MPA and the NMPA, real-world data on patients treated there can be collected and used as supplementary evidence in an NMPA registration application. Most products approved through this route have relied mainly on existing overseas data, supplemented by data from Chinese patients treated in Lecheng.

Reported results vary by source and date. One secondary source states that, as of January 2026, 47 licensed medical products had entered the programme, with the resulting evidence contributing to regulatory approvals for 22 products, 16 medical devices and six drugs. A later trade article reports Hainan figures of 27 drug and device products that had gained accelerated approval with support from Lecheng real-world evidence. These figures come from secondary reporting and could not be checked against official statistics for this brief.

The Lecheng guideline operates within a national framework for real-world evidence. The NMPA published its trial guidelines on real-world evidence supporting drug development and review on 7 January 2020. The Center for Drug Evaluation (CDE) has since issued further guidance, including a trial guideline on the design and protocol of real-world studies and a guideline on communication about registration applications supported by real-world evidence, released on 16 February 2023. A review by CDE authors describes how the core guidelines were later extended to areas such as oncology, rare diseases, paediatric medicines and traditional Chinese medicine.

On 26 January 2026, the NMPA issued Announcement No. 16 of 2026, confirming that it will apply ICH guideline M14 on non-interventional safety studies using RWD. Commentators note that M14 is a methods and reporting standard and does not by itself authorise the acceptance of any particular external or overseas dataset.

For overseas manufacturers, the guideline offers a more predictable route for converting clinical use in Lecheng into evidence for national registration. Sponsors should plan the Lecheng study from the outset with registration in mind, including protocol design, data collection and quality control, rather than treating routine clinical use as an evidence source after the event.

Data governance is a practical constraint. Real-world data generated in China generally cannot be transferred outside the country unless the applicable cross-border data requirements are met, which affects where analyses are performed and how global teams access results. Sponsors should also expect the NMPA to judge Lecheng data as one part of the evidence package, alongside overseas trial and post-marketing data, and should use the CDE communication procedures to agree the role of Lecheng evidence before submission.

Medical writers supporting such applications should make sure that study reports describe the Lecheng data source in enough detail for reviewers to assess it: the participating institutions, the period of data collection, how patients were identified, how outcomes were recorded and verified, and how the Lecheng population compares with the populations studied overseas. Clear cross-referencing between the Lecheng study report and the overseas clinical data will help reviewers see how the two sources fit together. Where the guideline’s staged process requires interim submissions or regulatory review points, teams should build these into project timelines from the outset.