China Foods for Special Medical Purpose: CFDA Finalized Supplementary Documents for FSMP Registration

Takehome:

The supplementary documents for FSMP registration have been finalized including FSMP registration application materials, labeling requirements, stability testing, and field inspection checkpoints.

On Jul. 14, 2016, China Food and Drug Administration (CFDA) finalized four supplementary documents in support of the “Administrative Measures for Registration of Foods for Medical Purpose” for trial implementation (see CL report on Apr. 19, 2016 for the drafting of relevant regulations), named:

• The requirements for FSMP registration application materials (for trial implementation);
• FSMP labeling requirements and users’ directions (for trial implementation);
• Requirements for FSMP stability research (for trial implementation);
• Field inspection checkpoints and judgment principles for FSMP manufacturers (for trial implementation)

Under the finalized regulation, field inspection items are classified into 8 parts including production capacity, R&D capacity, inspection capacity, production place, equipment and facilities, personnel, materials management, production process management, with a total of 24 inspection items, among which there are 5 critical inspection items, including manufacturing qualification, R&D capacity, establishment of production quality management system, production condition, and water used for production. The other 19 items are for regular inspection.

The quality management practice for FSMP clinical trial is still awaiting finalization by CFDA.

Other matching documents related to FSMP registration that may be released at a later include:

• FSMP naming principle
• Requirements on FSMP registration technical review
• Guidance for FSMP registration approval procedure
• Detailed rules for FSMP production licensing examination
• List of certified FSMP clinical trial institutes and inspection bodies

Reference link

CFDA No. 123 (2016) Announcement