By Fineline Cube 
The National Medical Products Administration (NMPA) issued a formal notice today announcing a pilot program aimed at streamlining the review and approval process for supplementary applications of overseas‑manufactured chemical drugs. The initiative empowers pilot departments in 14 provinces and municipalities to provide pre‑submission services to domestic responsible persons (DRPs) for major changes to such products.
What the Pilot Changes
| Aspect | Current Rule | Pilot Program Rule |
|---|---|---|
| Scope | All supplementary applications for overseas‑manufactured chemical drugs. | Applications that receive pre‑submission guidance, meet full dossier requirements and do not trigger an overseas registration inspection. |
| Review Timeline | Up to 200 working days. | Reduced to 60 working days once the pre‑submission service is completed. |
| Service Provider | Centralized NMPA review. | Pilot units (provincial/municipal drug‑regulation offices) deliver pre‑submission guidance and dossier‑preparation assistance. |
| Inspection Trigger | Automatic overseas registration inspection for many supplements. | CDE (Center for Drug Evaluation) decides if an inspection is needed; if so, CFDI (Center for Food and Drug Inspection) conducts it. |
How the New Workflow Works
- Pre‑Submission Service – The pilot unit in the applicant’s jurisdiction works with the Domestic Responsible Person (DRP) to review the supplement dossier, advise on regulatory gaps, and ensure completeness.
- Submission to CDE – After the pilot unit signs off, the Marketing Authorization Holder (MAH) files the supplementary application with the NMPA’s Center for Drug Evaluation (CDE).
- CDE Assessment – The CDE evaluates whether an overseas registration inspection is required based on the nature of the change and existing data.
- Inspection (if needed) – When required, the Center for Food and Drug Inspection (CFDI) organizes and executes the overseas inspection.
- Decision – If no inspection is needed, the CDE proceeds to a final decision within 60 working days.
Strategic Implications
- Accelerated Market Access – Faster approvals can shorten the time‑to‑market for foreign‑origin generics and reformulations, benefitting Chinese patients and reducing drug shortages.
- Cost Savings – MAHs avoid the expense and delay of overseas inspections when the pre‑submission service validates data integrity.
- Regional Competition – Provinces participating in the pilot may become attractive hubs for multinational pharma partners seeking quicker entry into China’s market.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the NMPA pilot program, anticipated timelines, and market effects. Actual outcomes may differ due to regulatory, operational, or market‑condition risks.-Fineline Info & Tech