China FSMP Registration 2025: 277 Approvals, Categories, Priority Reviews, and Label Guidance

Executive summary and data scope

As of September 30, 2025, China has approved 277 Foods for Special Medical Purposes (FSMP): 240 domestic and 37 imported. Approvals accelerated sharply after 2023, and renewal rates remain strong as 5‑year certificates cycle.

This blog organizes key data into clean tables and visuals, and clarifies how to identify FSMP national registration numbers on labels for consumer confidence.

Annual approvals, renewals, and cancellations

Approval trend 2017–2025

• First approval: 2017

• 2017–2022: each year ≤30 approvals

• Post‑2023: rapid acceleration; 2025 approvals: 46

• Origin shift: imports led in 2017–2019; domestic became mainstream after 2020

Certificate status snapshot

• Effective products: 264

• Cancelled: 13

• Completed renewals: 41 (FSMP certificates valid for 5 years)

• 2024 & earlier expiries: all renewed or cancelled except one product from 2017

• 2025 expiries: 14 products; renewal progress ~71%

Visual: Annual approvals bar chart (2017–2025) Visual: Renewals vs. cancellations stacked bar

Approved products by category and subtype

Category distribution (277 total)

Visual: Doughnut chart of category shares

Subtype breakdown

Notes:

• Infant FSMP emphasis: preterm/low birth weight (23) accounts for 34% of infant approvals.

• Non‑full‑nutrition mainstream: protein, electrolytes, and carbohydrate components together comprise 86% of non‑full‑nutrition approvals.

• Rare‑disease infant formulas: 3 products; two domestic approvals in 2025.

Company landscape and portfolio depth

Top companies by approved counts

Breadth of product types

• Infant FSMP breadth: Nestlé (6 types), Synutra/Shengtong (5), Nutricia (5), Aunuo (4)

• Non‑infant FSMP breadth: Dongze FSMP (6), Jilin Maifu (6), Shandong Ruoyao (5), Junyue Nutrition (5), AiSheng Tech (5), others (4)

• Dual‑domain coverage: Nestlé, Nutricia, Aunuo, Synutra/Shengtong span both infant and non‑infant; Jilin Maifu and Dongze FSMP specialize in non‑infant portfolios

Visual: Horizontal bar chart of top companies (counts) Visual: Matrix map of companies × type breadth

Origins, dosage forms, and scarce segments

Imported FSMP (37 approvals; 10 origins)

Domestic FSMP (240 approvals)

• Factories: 72 across 21 provinces

• Top provinces by approvals:

  • Jiangsu: 67 approvals, 13 factories (~28% of domestic; national #1)

  • Shandong: 35 approvals, 9 factories

  • Zhejiang: 20 approvals, 7 factories

• Combined: 122 approvals (44% of national total)

Dosage forms across all approvals

Visual: Map heat‑layer of domestic production clusters Visual: Pie chart of dosage forms

Scarce segments and priority review pipeline

Planned priority review admissions (2025):

• Amino acid metabolism disorder formulas (7)

• Diabetes full‑nutrition formulas (2)

• Infant high‑energy formula (1)

Visual: Pipeline timeline (priority categories and applicant examples)

How to read national registration numbers on FSMP

“Guo Shi Zhu Zi” (National Food Registration Number)

• Special foods under SAMR:

  • Infant formula milk powder: YP + year + sequence

  • FSMP: TY + year + sequence

  • Health foods: Domestic G + year + sequence; Imported J + year + sequence

• Indicates rigorous national approval; certificate validity typically 5 years

• Tip: for infant formula, the 5th digit distinguishes domestic (“0”) vs. imported (“5”)

“Guo Shi Zhu Shen” (Application stage)

• The acceptance code used during registration application; after approval, products adopt the formal “Guo Shi Zhu Zi” number.

Visual: Label close‑up with FSMP “little blue flower” icon and example registration code “国食注字TY2024XXXX” Visual: Side‑by‑side badge examples (“YP / TY / G / J” formats)

Consumer tips for selecting full‑nutrition FSMP

What to check on the label

• Basics: production date, shelf life, ingredient list, nutrition facts, formula characteristics, usage instructions

• Warnings & precautions: pay attention to contraindicated populations and special notes

Use under clinical guidance

• Diabetes: review carbohydrate sources and total carbohydrate content

• Kidney disease: review protein sources, protein content, and electrolytes (e.g., sodium, potassium, phosphorus)

• If discomfort occurs or expected outcomes are not met, consult a physician or clinical dietitian promptly.

Visual: Consumer checklist graphic (label essentials and clinical guidance prompts)

Conclusion

By Q3 2025, China’s 277 FSMP approvals reflect a phase of rapid and standardized industry development. A strong renewal pipeline, concentrated domestic manufacturing clusters, and expanding rare‑ and chronic‑disease segments indicate continued momentum. Clear labeling and informed selection remain essential to ensure FSMPs deliver safe, effective nutrition under medical supervision.

SINOFN's FSMP Lisence Number: SC13012011600311

EnQuanLi™ National Food Registration No.: TY20250016