By Fineline Cube The National Medical Products Administration (NMPA) issued Announcement No. 3, 2026 on further optimizing the review and approval of clinically urgent overseas marketed drugs, introducing priority review pathways, compressed testing timelines for rare disease drugs, and a Beijing pilot program to accelerate access to critical treatments.
Key Policy Provisions
| Provision | Detail |
|---|---|
| Global Simultaneous Development | Encourages simultaneous global R&D and China marketing applications; urgent overseas drugs eligible for priority review |
| Class I Communication | Applicants submit clinical urgency materials; CDE decides on trial approval within 30 days of acceptance |
| Trial Exemption | Drugs meeting criteria can submit direct marketing applications without clinical trials |
| Rare Disease Drug Testing | Sample testing shortened from 60 to 40 days; standard review + inspection from 90 to 70 days; sample quantity reduced to one batch (2x quality standard amount) |
| Priority Review Inspections | Risk‑based, coordinated with post‑market offshore inspections; on‑site or remote per risk level |
| Temporary Import Pilot | Beijing pioneering zone for rare disease drug supply; parallel evaluation, multiple uses after single customs clearance |
Regulatory Timeline Improvements
| Process | Previous Timeline | New Timeline | Improvement |
|---|---|---|---|
| CDE Trial Decision | 60 days | 30 days | 50% faster |
| Rare Drug Sample Testing | 60 days | 40 days | 33% faster |
| Rare Drug Inspection | 90 days | 70 days | 22% faster |
Strategic Impact
For Global Pharma: Clear pathway to bring urgent overseas drugs (e.g., rare disease therapies, oncology breakthroughs) to China 12‑18 months faster.
For Rare Diseases: 40‑70 day testing windows enable faster registration of orphan drugs already marketed abroad, addressing critical supply gaps in China.
For Beijing Pilot: Parallel evaluation and single customs clearance could reduce import timelines from 6‑12 months to 2‑3 months, serving 2‑3 million rare disease patients nationwide.
Market Context
China Rare Disease Drug Market: ¥35 billion (2025), growing at 25% CAGR; 80% of drugs are imported.
Overseas Approval Backlog: 300+ clinically urgent drugs awaiting China entry; priority review could unlock ¥80‑120 billion market value by 2028.
Policy Alignment: Supports Healthy China 2030 and dual circulation strategy by accelerating global innovation access.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA’s implementation timeline, CDE review capacity, and market impact of expedited approvals. Actual results may differ materially due to CDE resource constraints, provincial implementation variations, and international regulatory harmonization challenges.-Fineline Info & Tech