By Fineline Cube The National Medical Products Administration (NMPA) issued a notice ordering the immediate suspension of sales and use of Encorafenib Capsules (batch numbers 5G2T3 and 5G2T4) manufactured by PIERRE FABRE MEDICAMENT. The action follows an NMPA remote inspection that identified an unapproved major change to the manufacturing process of the active pharmaceutical ingredient (API) encorafenib — used in certain batches already released for sale in the Chinese market — constituting severe deviations from Good Manufacturing Practice (GMP).
Regulatory Action Snapshot
| Element | Detail |
|---|---|
| Regulator | National Medical Products Administration (NMPA) |
| Action | Immediate suspension of sales and use |
| Product | Encorafenib Capsules (Registration No.: GYZZ HJ20250082) |
| Manufacturer | PIERRE FABRE MEDICAMENT (France) |
| Affected Batches | 5G2T3, 5G2T4 |
| Violation | Unapproved major API manufacturing change; severe GMP deviations |
| Action Date | 26 Aug 2026 |
Inspection Findings & Violations
- Unapproved Manufacturing Change: A major change was made to the manufacturing process of the API encorafenib specified in the registration information, which has not yet been approved
- Unauthorized Market Release: The company used this API to produce certain batches of the drug product (batch numbers 5G2T3 and 5G2T4) and released them for sale in the Chinese market
- Quality System Failures: Change control and batch release review within the company’s quality management system severely deviated from GMP
- Regulatory Basis: The failures constitute non‑compliance with China’s Good Manufacturing Practice for Drugs (2010 Revision) and its appendices
- Inspection Method: The findings stem from a remote inspection organized by the NMPA
Market Impact & Outlook
- Supply Disruption in China: The suspension removes affected batches of encorafenib — a BRAF‑targeted oncology therapy — from the Chinese market, creating potential treatment access considerations while the matter is resolved.
- GMP Enforcement Signal: The decisive action underscores the NMPA’s zero‑tolerance stance on unauthorized post‑approval manufacturing changes, reinforcing expectations for rigorous change control across both domestic and overseas suppliers.
- Compliance Exposure: For PIERRE FABRE MEDICAMENT, the notice raises remediation priorities, including change‑control validation, batch release review overhauls, and potential follow‑up inspections before market restoration.
- Watch Items: The company’s corrective action plan, any broader batch recalls, NMPA follow‑up decisions on the API process change application, and the timeline for resuming normal commercial supply in China.
Forward‑Looking Statements – This brief is for informational purposes only and does not constitute investment, medical, or regulatory advice. Statements regarding remediation and market restoration are forward‑looking and subject to risks and uncertainties; actual outcomes may differ materially. Refer to official publications of the NMPA for authoritative details.-Fineline Info & Tech