Compliance Guideline on Food for Special Medical Purpose

Background

Food for special medical purposes (FSMP) has been used in China for about 40 years as "intestinal nutrition preparations", and had been supervised as medicines in China before 2012. The long-term applying experiences from developed countries show that, however, FSMP mainly play the role of nutrition support and supplement. Thus, in reality, they do not have specific therapeutic effects. In addition, if registered as drugs, most of FSMP cannot meet the corresponding requirements, thus, a large number of foreign products are not able to be imported into China to benefit the Chinese consumers with increasing demand.

Therefore, relevant Chinese departments have gradually managed FSMP as food, and the 2015 version of the Food Safety Law also clarified the legal status of FSMP as special food. Based on the experiences from developed countries and relevant domestic regulations, a series of standards and regulations have been promulgated as well, providing corresponding legal basis for the production, sale and supervision of FSMP in China.

CIRS Food Technical Team systematically introduces the definition, development status, laws and regulations, as well as market access of FSMP in this guideline based on the relevant domestic and foreign laws and regulations. It is expected that the guideline will help enterprises better understand the relevant standards and regulations of FSMP in China, so as to develop and/or import high-quality products to the Chinese market, serving Chinese consumers.

The Guideline can be divided as following

Section 1 Introduction of FSMP in China

* Further reading

How to Distinguish General Food, Health Food, FSMP and Drug in China?

A Brief Discussion on Raw Materials of FSMP in China

Summary and Analysis of Food Additives Permitted to be Used in FSMP

Raw Materials and Food Additives Permitted to be Used in FSMP for Infants in China

Section 2 Development status of FSMP in China

Section 3 Management system and relevant regulations of FSMP

* Further reading

Comparison of Domestic and Foreign Laws and Regulations on Foods for Special Medical Purposes

NHC Released Four Chinese Standards of Clinical Application Specification for FSMP and Specific Nutritionally Complete Foods (for cancer, diabetes and IBD)

Section 4 Market access of FSMP in China

* Further reading

Dossier Requirements of Foods for Special Medical Purpose (FSMP) Registration in China

Stability Research Requirements for Foods for Special Medical Purposes

Basic information

Editor:

CIRS Food Technical Team: Established in 2012, CIRS Food Technical Team has more than 80% masters with degrees of Food Safety or Food Engineering and more than 50% members from oversea renowned universities. Since it was founded, based on the rich experience of regulatory compliance and deep understanding of Chinese food regulations and industry, food specialists have made comprehensive and reasonable solutions for many oversea food companies to complete Chinese food regulatory compliance progress.