By Fineline Cube 
The National Medical Products Administration (NMPA) announced a new regulatory framework—Announcement No. 86 of 2025—that promises to streamline the review and approval of innovative drug clinical trials, cutting the process to 30 working days after receipt of application materials.
What the 30‑Day Pathway Covers
| Category | Eligible Drug Types | Key Eligibility Criteria |
|---|---|---|
| Traditional Chinese Medicine | Category 1 products | Must meet standard application requirements |
| Chemical Drugs | Category 1 products | Must be “key innovative” with significant clinical value |
| Biological Products | Category 1 products | Must align with national policy for full‑chain support |
The pathway also applies to:
- Children’s, rare‑disease, and TCM products identified by the Center for Drug Evaluation (CDE).
- Globally synchronized R&D programs: Phase I/II trials and Phase III international multicenter studies led or co‑led by a Chinese clinical‑trial institution.
Application Process
- Pre‑Submission – Applicants must conduct thorough ethical review and confirm the principal investigator’s compliance and capabilities.
- Submission – Indicate “30‑working‑day pathway” in the application form and provide all required documents.
- CDE Review – Acceptance decision within 5 working days; approval within 30 working days.
- Escalation – If technical complexity requires further consultation, the timeline extends to 60 days, with notification within 20 working days of acceptance.
All applicants are expected to initiate the clinical trial within 12 weeks of receiving approval.
Implications for the Pharmaceutical Landscape
- Speed to Market – The accelerated timeline aligns with global trends for rapid drug development, particularly for high‑impact therapies.
- Global Collaboration – By supporting internationally led studies, China positions itself as a key partner in worldwide R&D networks.
- Early‑Stage Innovation – The pathway incentivizes early‑stage research, potentially increasing the flow of novel agents into the Chinese market.-Fineline Info & Tech