China Consults on Administrative Measures for Registration of Foods for Special Medical Purpose

On Oct 18, 2021, State Administration for Market Regulation (SAMR) unveiled the exposure draft of “Administrative Measures for Registration of Foods for Special Medical Purpose”. Any comments should be sent back prior to Nov. 18, 2021 via http://www.moj.gov.cn,  http://www.chinalaw.gov.cn, http://www.samr.gov.cn, or sending e-mail to [email protected].

Compared with the current version, the proposed amendments can be summarized to following six aspects:

1. The registration requires higher standards

As the current GB standards are insufficient to cover the technical requirements of all FSMP products, the competent authority will emphasize the technical review during the registration to guarantee the products’ safety and efficacy.

In terms of the labeling, the label and specification cannot have function claims on the nutrients used in the FSMP products. Besides, the product name, category, registration number, suitable group and warning statement (please use under the direction of doctor or clinical dietitian) shall be indicated on the principal display panel.

2. The requirements for onsite inspection are detailed

After receiving the notification, the applicant has 30 working days to confirm the date of having onsite inspection. That is to say, it has 30 working days for the preparation. The competent authority will finish the inspection within 20 working days after the date that enterprise confirmed, but this time limit does not apply to overseas manufacturers. The onsite inspection will focus on the capability of R&D, production, inspection as well as the consistency between the application materials and the facts.

If necessary, the scope of inspection may extend to manufacturers of food raw materials and food additives.

3. The principle of clinical trial is included

Generally speaking, clinical trial is required when applying for the registration of specific complete nutrition formula. In this case, the applicant needs to submit the complete clinical trial report, as well as audit consent issued by Ethics Committee, clinical trial protocol, complete statistic analysis report and data, etc.

Besides, the inspection authority will check the authenticity, accuracy, completeness and traceability of clinical trial on the spot.

4. The supervision on FSMP registration is more stringent

The exposure draft specifies nine conditions subject to registration rejection, which are:

• The application materials are fake.

• The application materials cannot prove the products’ safety, nutrient sufficiency and clinical effect.

• The applicant is not equipped with qualified R&D capability, production capability or inspection capability.

• The applicant does not submit the supplementary materials within the time limit or the supplementary materials are unqualified.

• The applicant fails to confirm the onsite inspection within the time limit, rejects or is unwilling to coordinate the onsite inspection and sampling inspection work.

• The inspection report showcases it is inconsistent with the registration requirements.

• The product applied for registration by the same applicant is similar with its registered product formula of the same type.

• The same applicant uses one formula to apply for the registration of products having different names.

• Other conditions that are not consistent with the registration requirements in “Food Safety Law”, national food safety standards and technical requirements.

If the applicant is found illegal behaviors such as deceiving or providing false information during technical review, onsite inspection and sampling inspection, the applicant cannot withdraw the application and will be treated according to the law.

5. Designated products are given priority to the technical review

The exposure draft stipulates that the following FSMP products can apply for priority review:

• FSMP for rare diseases

• New type of FSMP which is in urgent clinical needs while has not been approved yet

• Other conditions specified by SAMR

For products subject to priority review, their review time limit is shortened to 30 working days and they are given priority to arranging the onsite inspection and sampling inspection. After full communication and confirmation, they are allowed to submit the technical materials later.

6. The requirements for registration alteration and renewal are updated

The applicant needs to submit the following documents when applying for registration alteration:

• Application form of FSMP registration alteration

• Product alteration demonstration report (new)

• Materials related to alterative items (new)

On the condition of unchanged food raw materials and food additives varieties, unchanged food ingredient list order and unchanged nutrition list, the usage amount of food raw materials and food additives is allowed to fluctuate within a proper scope, so enterprises do not need to apply for registration modification.

When it comes to the registration renewal, the major change lies in that the applicant needs to provide the report regarding production & sales conditions during the certificate validity period and suggestion of registration renewal verified by provincial food safety supervision departments. If the product is not produced and sold during the certificate validity period, it will not go through registration renewal.