Following the promulgation of the Administrative Measures for the Registration of Infant Milk Powder Formula (“Measures”) on 6 June 2016 and effective as of 1 October 2016, the China Food and Drug Administration ("CFDA") further promulgated two detailed rules on 16 November 2016, i.e. Application Documents and their Request for Registration of Infant Milk Power Formula (“Application Documents Request”) and Onsite Inspection Key Point and Judgment Principle for Registration of Infant Milk Power Formula (“Onsite Inspection Principle”).
The above two detailed rules, together with the Measures, constitute the rules on the registration of infant milk powder formula in China. Foreign infant milk powder manufacturers who intend to sell infant milk powder products in China are required to go through the registration formalities in compliance with the above Measures and detailed rules. With these detailed rules* , registration of infant milk powder formula can be thus implemented in practice.
A. Application Documents Request
Application Documents Request provides a guide for the preparation of documents and specific requests for each of the documents. According to the Application Documents Request, the following documents are required in order to register the infant milk powder formula:
- Application letter for the registration of infant milk powder formula;
- Entity qualification documents of the applicant;
- Quality and safety standards for raw materials;
- Product formula;
- R&D report of product formula;
- Statement on the production process;
- Product inspection reports;
- Supporting documents of R&D capacity, production capacity and inspection capacity;
- Other evidence of the scientific nature and safety of formula; and
- Sample of label and instruction, together with the explanation and supporting documents of its content.
Compared with the Measures, Application Documents Request additionally requires product formula and the sample of label and instruction to be submitted as part of the application documents.
According to the Application Documents Request, all the application documents shall be attached after the application letter in the sequence as listed in the application letter. All application documents shall be submitted in 1 original, 5 copies and 1 scan copy to be uploaded to the online system. Except for the application letter and inspection report issued by the competent institute, all the documents shall be affixed with company chop of the applicant each page or cross chop over all pages of the documents. For a foreign applicant, the documents shall be affixed with the company chop of its representative office or registration agent in China.
Further, the Application Documents Request also specifies the application documents and its request for changing the already registered formula and extension of such registration.
B. Onsite Inspection Principle
According to the Measures, the onsite inspection shall be applied to the domestic manufacturer and also the foreign manufacturer if the CFDA regards it necessary.
The Onsite Inspection Principle lists the category and item to be inspected, judgment standard and conclusion. According to the Onsite Inspection Principle, categories to be onsite inspected include: 1. Ability to Produce, 2. Ability to Inspect, 3. Ability to Research and Develop, and 4. Sample Trial Production. There are several items to be inspected under each category. For example, items under 1. Ability to Produce includes: temperature, humidity, air purity of the plant, plant layout, quality control personnel, purchase of raw material, supplement and packaging material, etc.
Conclusion after inspection consists of three types: 1. Fully Satisfy; 2. Partially Satisfy; and 3. Not Satisfy. According to the Onsite Inspection Principle, if all items Fully Satisfy the judgment principle, the authority shall make approval decision on the spot. If 4 items or less Partially Satisfy the judgment principle, the applicant shall improve such aspects and re-apply for onsite inspection towards such aspects. If any item does Not Satisfy the judgment principle, or 5 or more items Partially Satisfy the judgment principle, or the applicant delays in improving or fails to make improvement, the authority can make “Not Pass” decision.
The two detailed rules, together with the Measures, constitute the legal basis and the guide of application procedure for the manufacturers to prepare for the registration of their infant milk powder formula, including foreign manufacturers. As from 1 January 2018, all the formula infant milk powder to be sold or imported in China are required to have the registration certificate and attach the registration number in the products instruction.
It is also worth noting that in order to maintain the supply of infant milk powder product in the market, the CFDA provided a grace period for the infant milk powder products already approved to sell or already imported into China before the year 2018. According to a notice published by the CFDA on 30 September 2016, those already approved or imported products before 1 January 2018 are allowed to be sold on the market until their respective expiration date.
*According to the Measures, in principle each manufacturer is only allowed to register up to 3 formula series and 9 formulas in total.