Quick snapshot — What the measures cover

Shanghai drug and medical device reform is moving from policy into practice with a fresh municipal playbook announced on November 26, 2025.

Shanghai Municipal Government Office (Shanghai shi zhengfu bangongting 上海市政府办公厅) released a new set of measures titled “Several Measures to Deepen Comprehensive Reform of Drug and Medical Device Supervision and Promote High‑Quality Development of the Pharmaceutical Industry.”

These measures were explained at a press briefing on the afternoon of November 26, 2025.

Why investors, founders, techies, and marketers should care.

Shanghai is positioning itself as a national and international hub for life‑science innovation by clarifying five major reform directions that target faster approvals, clearer standards, and better cross‑sector collaboration.

Quick snapshot — What the measures cover

The measures clarify five major reform directions aimed at accelerating innovation, improving regulatory efficiency, and supporting the entire lifecycle from R&D to clinical use and export.

Five Key Reform Areas — clear, actionable changes for startups and incumbents

1. Carry Out National Pilot Tasks (national pilot programs)

Shanghai will take on central pilot programs including approval pathways for supplementary applications for drugs produced overseas.

The city will pilot dossier review for generic drugs to speed the launch of first generics.

The measures also encourage medical institutions to accelerate pilots for self‑developed use of in‑vitro diagnostic reagents (tiwai zhenduan 体外诊断).

2. Proactive, Local Innovation in Reform

Local innovations include piloting continuous manufacturing for pharmaceuticals.

The measures allow medical device (yiliao qixie 医疗器械) manufacturers to share laboratory resources to cut duplication and costs.

The city will refine procedures and guidance for post‑marketing changes to already‑approved products.

3. Full‑Chain Service Innovations — standards, export testing, and global trials

The measures focus on the full chain from R&D to clinical use.

Specific actions include:

• Active participation in national and international standards development for drugs and devices.
• Promoting standards research for frontier technologies such as brain–computer interfaces (naoji jiekou 脑机接口), cell and gene therapies (xi bao yu ji yin zhiliao 细胞与基因治疗), and standards for traditional Chinese medicine (zhongyao 中药).
• Supporting group standards for digital traceability across drug and device production processes.
• Helping domestic enterprises “go global” by providing testing services with international recognition and supporting international multicenter clinical trials for innovative drugs and devices in Shanghai.
• Broadening export certification scope for medical devices to smooth commercialization outside China.

4. Strengthen Departmental Coordination and “Three‑Medical” Linkages

Measures deepen cross‑sector collaboration among hospitals, research institutions, and pharmaceutical firms.

They encourage joint platforms for innovation and industrialization of traditional Chinese medicine.

The city will explore early import channels for clinically urgent orphan drugs and devices not yet registered domestically at specific medical institutions.

Mechanisms will be coordinated to collect clinical effectiveness feedback for drugs purchased through centralized procurement.

5. Improve Approval Quality and Efficiency — “Regulation to Accelerate”

Shanghai commits to cutting review and approval timelines where appropriate.

Key commitments include:

• Shortening clinical trial review timelines for eligible innovative drugs (chuangxin yao 创新药).
• Reducing batch‑release (批签发) time limits for seasonal influenza vaccines (jijiexing liugan yimiao 季节性流感疫苗).
• Compressing the average first‑time registration cycle for Class II medical devices by six months.
• Exploring efficient linkage mechanisms that move “new and superior drugs/devices” quickly from development into clinical use.
• Optimizing admission processes for irreplaceable new drugs used in urgent and critical care.

Local regulation context — continuity with the March 2025 ordinance

The measures are designed to align with and implement 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).

That regulation came into force on March 1, 2025.

The regulation is described as the nation’s first local statute that integrates regulatory controls with promotion measures.

The new “Several Measures” ensure policy continuity and practical implementation of that ordinance at the municipal level.

What this means for stakeholders — practical takeaways

Startups and founders:

• Expect clearer local pilot routes for first‑in‑class generics and foreign‑produced drug supplementary applications.
• Greater support for standards research in frontier areas like brain–computer interfaces and cell and gene therapy helps reduce technical and regulatory uncertainty.

Pharma and device R&D teams:

• Shorter clinical trial and registration timelines make faster go‑to‑market strategies viable in Shanghai.
• Shared labs and continuous manufacturing pilots can reduce CapEx hurdles for scaling production.

Clinical institutions and hospitals:

• New mechanisms enable faster access to clinically urgent orphan drugs and devices through early import channels at designated institutions.
• Coordinated clinical feedback loops from centralized procurement may influence formulary and sourcing decisions faster.

International investors and exporters:

• Testing services with international recognition and support for multicenter trials in Shanghai lower barriers for Chinese products seeking global markets.
• Broadened export certification for devices helps scale cross‑border commercialization efforts.

Impact on frontier tech — why brain–computer interfaces and cell/gene therapy get special attention

Shanghai explicitly calls out standards research for frontier technologies such as brain–computer interfaces (naoji jiekou 脑机接口) and cell and gene therapies (xi bao yu ji yin zhiliao 细胞与基因治疗).

Standards work matters because it creates predictable ramps for product development and regulatory review.

For innovators in these fields, better standards mean:

• Less ambiguity during trials and device validation.
• Better alignment with international testing expectations when pursuing export markets.

Vaccine and device timing — faster patient access

The measures promise to reduce batch‑release limits for seasonal influenza vaccines and shorten registration cycles for Class II medical devices.

That change should accelerate patient access to updated vaccines and improved devices without lowering oversight quality.

Bottom line

Shanghai is sharpening the policy toolkit to support both domestic innovation and global competitiveness in drugs and medical devices.

Expect shorter approvals, stronger standards for frontier technologies, and better coordination across hospitals, regulators, and industry.

This is a municipal playbook designed to turn regulatory clarity into faster innovation cycles and smoother export pathways.

Note: This article summarizes the municipal measures announced at the November 26, 2025 press briefing.

This content does not provide investment advice.

Shanghai drug and medical device reform is now focused on standards research and faster approvals.

References

• 上海：推进脑机接口等前沿技术的标准研究，缩短季节性流感疫苗的批签发时限 – 上观新闻
• 上海：推进脑机接口等前沿技术的标准研究，缩短季节性流感疫苗的批签发时限 – 东方财富网
• Shanghai Municipal People’s Government – 上海市人民政府