On October 22, 2024, China’s State Administration for Market Regulation (SAMR) introduced the Working Procedures for Priority Review and Approval of Foods for Special Medical Purposes Registration (referred to as the “Working Procedures”). This new regulation sets out guidelines for priority registration review to accelerate market access for certain Foods for Special Medical Purposes (FSMP). Effective immediately, these procedures outline the eligible scope and application steps for priority review.

Key Eligibility Criteria for Priority Review

According to the Working Procedures, the following FSMP products are eligible for expedited review:

1. FSMP for Rare Diseases: This category includes products designed to manage rare conditions such as phenylketonuria, maple syrup urine disease, methylmalonic acidemia, tyrosinemia, homocystinuria, glutaric acidemia type I, isovaleric acidemia, and urea cycle disorders.
2. New Clinically Urgent FSMP: Priority review applies to innovative products that have not yet been approved but address critical clinical needs. Examples include complete nutrition formulas for managing conditions like diabetes, respiratory diseases, kidney and liver diseases, sarcopenia, infections, post-surgery recovery, inflammatory bowel disease, food protein allergies, refractory epilepsy, gastrointestinal absorption disorders, pancreatitis, abnormal fatty acid metabolism, obesity, and post-fat reduction surgery care.
3. Other Circumstances: As stipulated by SAMR, additional situations may also qualify for priority review under the new guidelines.