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2026-09-14 00:00 China Policy & Regulation Industrial Planning Translated from ZH

Jiangxi Sets 10-Day Clock for Mutual Recognition of BCI Ethics Reviews

Summary Jiangxi issued BCI support measures on November 26, 2025 that set no numeric targets but called for mutual recognition of clinical research ethics reviews, and its health commission followed on May 26, 2026 with guidance requiring participating sites to finish recognition reviews within 10 working days. Invasive projects for neurological or psychiatric treatment also need provincial expert review within 20 working days.
Why it matters Repeated ethics reviews at every site are one of the slowest steps in multicenter BCI trials, and Jiangxi is the only province so far to follow a policy pledge with binding deadlines within six months.

BCIwiki (bciwiki.com) — In a multicenter clinical trial of a brain-computer interface product, each participating hospital’s ethics committee reviews the same protocol independently, and every protocol change triggers another round at every site. Support measures issued on November 26, 2025 by the General Office of the Jiangxi Provincial People’s Government in eastern China wrote a fix for this into provincial policy.

The main document, numbered Ganfuting Fa [2025] No. 29, sets out 11 tasks in four areas. A companion ethics review guideline for BCI clinical research, numbered Ganwei Kejiao Fa [2026] No. 8, was issued by the provincial health commission on May 26, 2026.

Jiangxi was the first province to issue a BCI policy after the national seven-ministry guidelines of July 23, 2025, more than three months before Jiangsu. It was also the first to issue one through the provincial government’s general office, after Beijing, Shanghai, Sichuan and Shandong had issued theirs through departments; Tianjin, Anhui and Zhejiang later used the same format.

Jiangxi’s measures are the only main provincial document with no numeric targets. The province’s BCI industry base is thin, concentrated in the Ganjiang New Area, and pledging numbers of leading companies or industry size from that starting point would be hard to deliver. The document lists concrete actions instead, from organized research to a safety service system.

Several actions are detailed. The platform task encourages animal testing platforms and proof-of-concept centers, since invasive BCI development requires costly, slow and tightly regulated large-animal studies. The application task lists national defense among scenarios. The regulatory task offers early engagement and case-by-case service for companies and a provincial product testing center.

Task 11 calls for mutual recognition of clinical research ethics reviews: once the lead site’s ethics committee approves a study, participating sites accept that decision instead of reviewing the protocol again. For a trial spanning five or six hospitals, repeated reviews can take six months to a year.

The guideline turned this into procedure. The lead site conducts the full initial review, and participating sites complete their review within 10 working days of receiving complete materials, examining only their own research conditions, staff qualifications and informed consent process. The lead site files its approval with the provincial medical ethics expert committee within 10 working days.

Projects using invasive BCIs to treat neurological or psychiatric disorders also require review by the provincial expert committee, completed within 20 working days of acceptance, with an opinion issued within seven working days after that. Sharing responsibility for high-risk projects at the provincial level gives hospital committees the confidence to accept each other’s decisions.

The guideline also asks committees to set BCI-specific assessment points, including long-term safety of invasive procedures, privacy and life-cycle management of neural data, potential effects on participants’ mental and personal integrity, supported decision-making for participants with cognitive impairment, and long-term follow-up and voluntary withdrawal. Jiangxi is so far the only province to follow a main document with a detailed companion rule within six months.

On the industry side, Jiangxi concentrates resources in the Ganjiang New Area. The province issued measures in December 2025 to support the area as a future industry pilot zone, and in May 2026 the provincial governor conducted a study tour on BCI technology and industry innovation.

Pricing came before the main document. Jiangxi’s BCI service prices took effect on November 1, 2025. At provincial hospitals in Nanchang, invasive implantation is RMB 6,500, removal RMB 3,100 and non-invasive fitting RMB 960, with children’s surcharges listed separately as RMB 1,950 and RMB 930, equal to 30%. The payment category column reads self-paid.

One pricing rule concerns data. If fitting data such as EEG, neural or EMG signals are not uploaded as required, the fee is reduced by RMB 30, a rule Zhejiang also uses. The amount is small, but it writes clinical data collection into the pricing rules.

Execution is the next test: how many hospitals use the recognition process, which multicenter trial goes through it first, and whether participating sites use the review of their own conditions to re-examine protocols. Without numeric targets, how to evaluate the document in a few years remains open.

Compiled by BCIwiki from public sources

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2026-05 Jiangxi Provincial Health Commission Jiangxi Sets 10-Day Clock on BCI Ethics Review 2025-11 General Office of the Jiangxi Provincial People's Government Jiangxi Floats Mutual Ethics Review for BCI
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