NMPA Drug Approvals Surge in 2025: Record 61 First Global Approvals Signal Accelerated Market Access
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The National Medical Products Administration (NMPA) approved a record 61 drugs for first global approval in 2025, spanning modalities from small molecules to cell and gene therapies. New regulatory measures on contract manufacturing and pre-approval importation signal a more agile yet controlled approval environment for BD teams and investors.
Executive Summary
- The NMPA approved 61 drugs for first global approval in 2025, a record high, up from 46 Class 1/1.1 innovative drugs in 2024.
- New regulatory measures include stricter oversight of contract manufacturing (Announcement No. 134) and a pathway for pre-approval importation of overseas-marketed drugs (No. 96).
- Export certificate requirements tighten for pharmaceutical manufacturers, effective January 1, 2026.
Show 1 more takeaway
- BD teams and investors should reassess China market entry strategies given faster approval timelines and evolving compliance obligations.
Market Impact
| Regulatory | high |
|---|---|
| Commercial | high |
| Competitive | medium |
| Investment | high |
NMPA Drug Approvals Surge in 2025: Record 61 First Global Approvals Signal Accelerated Market Access
The National Medical Products Administration (NMPA) approved a record 61 drugs for first global approval in 2025, spanning modalities from small molecules to cell and gene therapies. New regulatory measures on contract manufacturing and pre-approval importation signal a more agile yet controlled approval environment for BD teams and investors.
Key Takeaways
- The NMPA approved 61 drugs for first global approval in 2025, a record high, up from 46 Class 1/1.1 innovative drugs in 2024.
- New regulatory measures include stricter oversight of contract manufacturing (Announcement No. 134) and a pathway for pre-approval importation of overseas-marketed drugs (No. 96).
- Export certificate requirements tighten for pharmaceutical manufacturers, effective January 1, 2026.
- BD teams and investors should reassess China market entry strategies given faster approval timelines and evolving compliance obligations.
The development
The National Medical Products Administration has accelerated drug approvals, with 61 drugs receiving their first global approval in China in 2025, compared to 46 Class 1 or 1.1 innovative drugs in 2024. The approved modalities include small molecules, monoclonal antibodies, vaccines, antibody-drug conjugates, and cell and gene therapies. Concurrently, the NMPA issued Announcement No. 134, 2025 to strengthen supervision of contract manufacturing, and Announcement No. 96, 2025 to allow importation of pre-approval commercial-scale batches of overseas-marketed drugs for early patient access. Additionally, the Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers (No. 113, 2025) will take effect on January 1, 2026.
The surge in first global approvals marks a strategic shift: China is no longer a lagging market for innovative therapies but an early launch destination. In 2024, 46 Class 1 or 1.1 innovative drugs were approved, with 39 originating from domestic developers. The 2025 tally of 61 globally-first launches suggests the NMPA’s review timelines are compressing and its willingness to accept foreign clinical data for early access is growing.
Implications for pharma teams
For BD teams, the record number of first global approvals signals a more receptive NMPA environment for innovative therapies, potentially reducing time-to-market for drugs targeting China. Investors should note the shift toward domestic innovation (39 of 46 approvals in 2024 were domestic) and the increasing diversity of modalities, which may affect portfolio valuations. The new contract manufacturing rules (No. 134) require CMOs and sponsors to enhance quality agreements and oversight, impacting deal structures. The pre-approval import pathway (No. 96) offers a strategic lever for companies with overseas-marketed drugs to establish early market presence. Exporters must prepare for the January 2026 certificate requirements, which could affect supply chain timelines. Overall, the NMPA's dual focus on speed and control demands proactive compliance and regulatory intelligence.
Frequently Asked Questions
What does the record number of first global approvals mean for foreign drugmakers?
Foreign companies can now consider China as a potential first-launch market, especially for therapies addressing urgent clinical needs. The NMPA has shown willingness to accept overseas data and expedite reviews, though all imported drugs and APIs must still undergo a separate registration process. The pre-approval importation pathway (No. 96) lets companies bring in commercial-scale batches of already-approved overseas drugs for early patient use before Chinese approval is finalized.
How will the new contract manufacturing rules affect existing partnerships?
Announcement No. 134, issued in 2025, tightens oversight of drug contract manufacturing. Marketing authorization holders and contract manufacturers must jointly assume primary responsibility for quality and safety. BD teams negotiating new CMO agreements should expect stricter quality clauses, while existing partnerships may need contract amendments to align with the enhanced supervisory framework.
When do the new export certificate requirements take effect?
The Administrative Provisions on Inspection and Export Certificate for Pharmaceutical Products Exported by Pharmaceutical Manufacturers (No. 113, 2025) come into force on January 1, 2026. Exporters should begin preparing now — the rules mandate a standardized inspection and certification process for pharmaceutical products leaving China, which could introduce new lead times and documentation requirements.
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