CCIC North America Consulting

11/26/2020 SAMR

On November 26th, 2020 SAMR officially issued the “Work Regulations for On-site Inspection of Special Food Registration (Interim)” (hereinafter referred to as the “Working Procedures”).

The main points of this “Working Procedures” are:

• In order to strengthen the management of special food registration and standardize the on-site verification of special food registration, in accordance with the “Food Safety Law of the People’s Republic of China”, “Dietary Supplement Registration and Filing Management Measures”, ” Registration Management Measures of Infant Formula Powder Product “, ” Registration Management Measures of Special Medical Purpose Formulas” and other laws, formulating this regulation.
• When necessary, extended inspections can be carried out on the production links of raw materials, auxiliary materials, packaging materials, etc.
• On-site verification is to reviewing the development, production (or production in trial), inspection conditions, capabilities, and original data and clinical trials of special food products or formulas, and to verifying the production (or production in trial) process to evaluate the registration application data and whether the actual situation is consistent.
• Applicant of special food registration shall prepare to accept on-site registration verification after submitting the registration form, and assist in sending samples for inspection according to the requirements of verification work.
• The Center of Food Evaluation shall organize a team of on-site registration inspection according to the specific requirements of the on-site registration inspection. Each inspection team generally consists of 3 to 5 inspectors, and the inspectors participating in the on-site registration inspection are randomly selected from the special food inspector list.
• The language of the working inspectors for overseas inspection of imported special foods shall be in Chinese. The primary inspection materials submitted by the inspected enterprise shall be in Chinese, and other foreign language materials required for inspection shall be provided with Chinese translations.  During the verification period, the verified enterprise shall be providing translators who meet the requirements of verification work.  The verified enterprise shall be fully responsible for any errors caused by language translation.

Source:

http://gkml.samr.gov.cn/nsjg/tssps/202011/t20201126_323895.html