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1 min read
Introduction
China is undergoing one of its most ambitious Regulatory transformations in recent decades. From late 2025 onward, the National Medical Products Administration (NMPA) has rolled out new regulations affecting pharmaceuticals and medical devices, including tighter controls on excipients, packaging materials, enhanced GMP requirements, and lifecycle oversight of products. For global pharmaceutical companies, grasping these changes early is vital to securing timely approvals and ensuring market access.
Key Regulatory Changes in 2025–2026
- New controls on excipients & packaging materials: Guidance on the Inspection of Pharmaceutical Excipients and Guidance on the Inspection of Pharmaceutical Packaging Materials were released in Nov 2025 following the GMPs requirements on them in Jan 2025 to enhance the implementation and compliance.
- Lifecycle regulation for drugs & devices: NMPA is enforcing end-to-end Regulatory oversight covering clinical trials, approval, post-market surveillance, and periodic re-evaluations, effectively aligning China with global Regulatory practices.
- Stricter GMP & supply‑chain audits: The reform expands GMP expectations and increases inspection frequency, especially for imported products and high-risk categories like biologics, injectables, and inhalation and Ophthalmic preparations.
- Faster review pathways for innovative therapies: NMPA is prioritizing novel therapies, oncology drugs, and high-need medicines, offering conditional approvals and accelerated review routes with adequate post-market commitments.
Why 2026 Entry Strategy Must Adapt
- Document preparedness: Dossiers requirements for DMF and/or binding review of API, excipients and packaging materials are category-based. Good strategy shall facilitate the NDA approval and marketing access
- Lifecycle compliance: Companies must be ready for ongoing pharmacovigilance, periodic re‑assessments, and post-market CMC management.
- Risk-based quality systems: With expanded GMP scrutiny and inspections, firms must enhance their quality systems, supplier oversight, and inspection readiness.
- Strategic asset planning: For global launches or device‑drug combos, early strategic planning is essential to leverage the new accelerated pathways.
Recommendations for Pharma Companies
- Conduct a full gap‑analysis on excipients, packaging, and API compliance for the China market entry.
- Update CMC, stability, and GMP documentation to meet the new Regulatory baseline.
- Build robust post-market surveillance and data‑management systems for lifecycle compliance.
- For innovative therapies, align dossiers with conditional‑approval expectations and plan for post-market commitments.
Conclusion
China’s 2025–2027 Regulatory overhaul reflects an ambitious shift toward global‑standard pharmaceutical oversight. Firms that proactively align with the new regulations in excipients, GMP, lifecycle management, and dossier quality will secure regulatory advantage and long-term market access.
Want a head start on China compliance for 2026? Our Regulatory experts will help you update your dossiers, ensure GMP readiness, and navigate NMPA’s new requirements. Contact us today.
