By Fineline Cube 
China’s National Medical Products Administration (NMPA) released the “Regulations on Inspection and Export Certification Management for Drug Manufacturers Exporting Drugs,” effective January 1, 2026, expanding export certificate eligibility to all GMP‑compliant manufacturers regardless of domestic approval status and extending certificate validity to 3 years.
Regulatory Milestone
| Item | Detail |
|---|---|
| Regulation | Regulations on Inspection and Export Certification Management |
| Issuing Agency | NMPA (China) |
| Publication Date | 17 Nov 2025 |
| Effective Date | 1 Jan 2026 |
| Scope | All drugs produced in China for export (preparations, APIs, TCM granules, intermediates) |
| Key Innovation | Export certification now available regardless of domestic marketing approval |
Key Facilitating Measures
| Measure | Details |
|---|---|
| Expanded Certification Scope | All GMP‑compliant export drugs eligible for certificates, even if not approved in China |
| Extended Validity | “Drug Export Sales Certificate” validity increased from 2 years to 3 years, aligning with EU API certificate duration |
| Processing Time Limit | Provincial authorities must issue certificates within 20 working days |
| Intermediates Eligibility | Pharmaceutical preparation intermediates may apply for export certificates |
| Template Update | Adopts WHO 2021 recommended format for export certificates |
Market Impact & Outlook
- Export Market Size: China’s pharmaceutical exports reached $85 billion in 2024; the new regulations could accelerate growth by 8‑12% annually by reducing administrative barriers
- API Exporters: 1,200+ API manufacturers stand to benefit from streamlined certification and extended validity, reducing renewal costs by 30‑40%
- Unapproved Products: Estimated 15‑20% of China’s export portfolio consists of products not marketed domestically; these now gain formal certification pathway
- Global Competitiveness: Harmonization with WHO standards and EU timelines strengthens China’s position vs. India and Europe in global supply chain
- Compliance Requirements: New rules also impose stricter documentation and contract manufacturing oversight, potentially raising compliance costs for smaller exporters by 5‑10%
Forward-Looking Statements
This brief contains forward‑looking statements regarding the implementation impact of NMPA’s export certification regulations on China’s pharmaceutical export market. Actual results may differ materially due to variability in provincial enforcement, global demand fluctuations, and changes in importing country requirements.-Fineline Info & Tech