The General Office of the State Administration for Market Regulation ("SAMR") has recently issued the Rules on the Examination of Production Licensing for Foods for Special Medical Purposes (Draft for Comment) (the "Draft for Comment") for public comment by November 20, 2018.
The Draft for Comment covers the general provisions, production sites, equipment and facilities, layout of equipment and technological processes, personnel management, management systems, qualification test reports for trial products, etc. Among others, the Draft for Comment provides that, enterprises producing foods for special medical purposes ("FSMPs") shall organize their production activities in line with relevant technical requirements, such as the approved registered product formula and the technological processes, and are banned from producing FSMPs by means of sub-packaging. Moreover, the Draft for Comment requires the establishment of 13 requirements to effectively control key production processes, including "controlling when and at what temperature production and processing may take place", "laying down requirements for the control of personal hygiene" and "working out requirements for products produced on the same production line and risk assessment management". Meanwhile, FSMP producers shall each set up a system for the recall of unsafe products and a system for the management of substandard products.