The newly revised "Food Safety Law" was formally implemented on October 1, 2015, which specifically lists the supervision of special foods. The new food safety law lists special foods as health foods, FSMP, and infant formulas. What are the special standards and regulations for FSMP as a type of food in special foods? For this purpose, the Foodmate Standards Center has made a special summary for reference.
Among these standards and regulations, it is worth mentioning that the “FSMP Registration Management Regulations” (hereinafter referred to as “Measures”) released by the State Administration of Pharmacy in March 2016 is the first in China dedicated to special medicines. Regulations for the formulation of regulatory foods. The “Measures” were implemented on July 1, 2016. They were formulated and enacted on the basis of the requirements of Article 80 of the Newly Revised Food Safety Law. They apply to the registration management of FSMP that are produced, sold, and imported within the territory of the People's Republic of China. “Measures” does not apply to the preparation of nutritious meals for patients by medical institutions.
The summary of FSMP standard and regulations
Administrative Measures for Registration of Foods for Special Medical Purpose (2015)
FSMP registration Application Items and Requirements (Trial) (2017 Revision)
FSMP label, instructions sample draft requirement (trial)（2016）
FSMP stability study requirements (trial) (2017 Revision)
FSMP registered production companies on-site check points and judgment principles (trial)（2016）
FSMP clinical trial quality management specification (trial)（2016）
Special food registration on-site verification of implementation specifications (draft) （2017）
FSMP guiding principles for clinical trials of nephropathy (draft for soliciting opinions)（2018）
FSMP muscular decay syndrome clinical trial guidelines（draft for soliciting opinions）（2018）
FSMP clinical guidelines for inflammatory bowel disease（draft for soliciting opinions）（2017）
FSMP clinical trial guidelines（draft for soliciting opinions）（2017）
GB 25596-2010 National food safety standard General provisions for infant formula for special medical purpose
GB 29922-2013 National food safety standard General provisions for food for special medical purpose
GB 14880-2012 National food safety standard The use standard of food nutrition fortifier
GB 2760-2014 National food safety standard The use standard of food additives
GB 13432-2013 National food safety standard Label for pre-package special foods
GB 7718-2011 National food safety standard The general principles of the prepackaged food labels
GB 29923-2013 National food safety standard Food for special medical purpose enterprise good manufacturing practices