brain–computer interfaces — Shanghai moves to advance standards and speed vaccine batch release

Key Points

New Measures align with local law: Issued to implement the Shanghai Regulations on the Administration of Drugs and Medical Devices (effective March 1, 2025) and to speed approvals and standards across Shanghai 上海’s drug and device ecosystem.
Faster approvals and batch release: The Measures will compress review time for eligible innovative trials, shorten batch release (piqianfa 批签发) timelines for seasonal influenza vaccines, and reduce the average first‑time registration cycle for Class II medical devices by six months.
Standards and pilots for frontier tech: Shanghai will promote standard research and pilots for areas like brain–computer interfaces (naoji jiekou 脑机接口) and cell and gene therapies, supporting safe, standardized innovation.
Infrastructure to lower commercialization barriers: Policies support shared laboratories, continuous manufacturing pilots, and expanded international testing and export support to help startups and manufacturers scale faster.

Source: Shangguan News (Shangguan Xinwen 上观新闻)

Quick take:

The Shanghai Municipal Government Office (Shanghai Municipal Government Office 上海市政府办公厅) issued a policy package called “Measures for Deepening Comprehensive Reform of Drug and Medical Device Regulation to Promote the High‑Quality Development of the Pharmaceutical Industry”.

That package is referred to below as the Measures.

The Measures aim to align with Shanghai’s new local ordinance and to speed up approvals and standards work across drugs and medical devices.

This article breaks down the five reform priorities, explains what they mean for investors, founders, techies, and marketers, and flags what to watch next.

Five reform priorities — what’s changing in Shanghai

Guo Shuting (Guo Shuting 郭术廷), deputy director of the Shanghai Municipal Drug Supervision and Administration Bureau (Shanghai Municipal Drug Supervision and Administration Bureau 上海市药品监督管理局), summarized the Measures around five core areas.

1. Taking on national pilot reform tasks

Accept supplementary registration applications for drugs produced overseas.
Pilot dossier review for generic drugs to accelerate first generics to market (shoufang 首仿).
Encourage hospitals to pilot self‑developed use of in vitro diagnostics (tiwai zhenduan 体外诊断试剂).

2. Shanghai‑led innovation in reform practices

Pilot continuous manufacturing for drugs to modernize production workflows.
Enable medical device manufacturers to share laboratory resources and reduce duplicated capital spending.
Improve procedures for post‑approval changes to marketed drugs so products can adapt faster to real‑world needs.

3. End‑to‑end service innovation — R&D to use

Coordinate functions across departments to streamline research, production, approval, and clinical use.
Actively participate in national and international standard setting for both drugs and devices.
Promote standard research for frontier technologies such as brain–computer interfaces (naoji jiekou 脑机接口), cell and gene therapies (xibao yu jiyin zhilia o 细胞与基因治疗), and traditional Chinese medicine (zhongyiyao 中医药).
Support drafting industry group standards for digital traceability across drug and device production.
Help domestic medical products “go global” via internationally recognized testing services and expanded export certificates.
Support international multi‑center clinical trials for innovative drugs and devices conducted in Shanghai.

4. Strengthening departmental coordination & deepening the “three‑medical” linkage

Encourage collaborative platforms between hospitals, research institutes, and drug firms for traditional Chinese medicine innovation and industrialization.
Explore emergency import pathways for urgently needed drugs and devices not yet registered domestically at certain medical institutions.
Coordinate mechanisms to collect efficacy feedback for drugs bought via centralized purchasing.

5. Improving approval quality and efficiency — “regulation to accelerate”

Compress review time for eligible innovative drug clinical trials when conditions are met.
Shorten batch release (piqianfa 批签发) timelines for seasonal influenza vaccines.
Reduce the average first‑time registration cycle for Class II medical devices by six months.
Pilot efficient linkage mechanisms to speed high‑value new drugs and devices from R&D into clinical use.
Optimize hospital admission processes for irreplaceable new drugs used in critical care.

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How this ties into Shanghai’s local regulation

The Measures were issued to align with the “Shanghai Regulations on the Administration of Drugs and Medical Devices” (Shanghai shi yaopin he yiliao qixie guanli tiaoli 上海市药品和医疗器械管理条例), effective March 1, 2025.

That ordinance is China’s first local regulation that intentionally combines regulatory oversight with promotion measures.

The Measures are designed to ensure policy continuity and effective implementation under that new ordinance’s framework.

Why investors, founders and industry leaders should care

Faster batch release for seasonal influenza vaccines means quicker public access during flu season and improved preparedness for outbreaks.
Standard‑setting and pilots in frontier areas like brain–computer interfaces and cell and gene therapies create an environment for safe, standardized innovation.
Expanded international testing and export support can help Shanghai companies scale cross‑border and boost global recognition.
Shared labs and continuous manufacturing pilots may lower capital barriers for medtech startups and accelerate commercialization timelines.

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Practical implications — what founders and R&D teams should do now

Map current projects to the Measures and flag opportunities for pilot participation.
Engage regulators early if you’re working on brain–computer interfaces, cell and gene therapies, or novel in vitro diagnostics.
Plan for shared resource models — labs and testing services may be more accessible under new pilots.
Prepare documentation for international multi‑center trials if you intend to use Shanghai as a global trial hub.

What to watch next

Specific implementation details and timelines for the pilots and approval time reductions are the next items to monitor.

Stakeholders should expect further guidance on:

Continuous manufacturing pilots and how they’ll be evaluated.
Shared laboratory models and rules for resource access.
Standards work for brain–computer interfaces and cell/gene therapies, including any draft technical specifications.
Practical steps for emergency import of unregistered but critical products at designated hospitals.

Key terms — quick glossary

Shanghai (Shanghai 上海)
brain–computer interface (naoji jiekou 脑机接口)
in vitro diagnostics (tiwai zhenduan 体外诊断)
traditional Chinese medicine (zhongyiyao 中医药)
innovative drugs (chuangxin yao 创新药)
batch release (piqianfa 批签发)

Bottom line

The Measures sharpen Shanghai’s playbook for faster approvals, stronger standards, and better coordination across the drug and medical device ecosystem.

They specifically accelerate work on brain–computer interfaces, shorten vaccine batch release timelines, and set up practical pilots for manufacturing and shared infrastructure.

If you’re investing in or building in China’s medtech and biotech space, these moves are worth immediate attention.

Keyword reminder: brain–computer interfaces