The dietary supplement technical evaluation from CFDA experts on the registration materials is very important. According to the notice of main points about the dietary supplement technical evaluation, CFDA experts will make the four below conclusions after the dietary supplement technical evaluation:
I. Recommended its approval
II. Recommended its approval after further materials provided
III. Re- technical evaluation after further materials provided
IV. Recommended its disapproval
I. Recommended its approval: If the materials provided by applicant are integrated and authentic, then further materials will not be required and dietary supplement registration certificate will be issued by CFDA after administrative examination.
II. CFDA experts will make the conclusion of "Recommended its approval after further materials provided" if the registration materials meet the following criteria：
I. Recommended its approval
II. Recommended its approval after further materials provided
III. Re- technical evaluation after further materials provided
IV. Recommended its disapproval
I. Recommended its approval: If the materials provided by applicant are integrated and authentic, then further materials will not be required and dietary supplement registration certificate will be issued by CFDA after administrative examination.
II. CFDA experts will make the conclusion of "Recommended its approval after further materials provided" if the registration materials meet the following criteria：
| NO. | Basic Content | Specific Content |
| 1 | The R＆D Report | Research and development report meets the basic requirements, however, the applicant needs to further improve the R＆D materials of formula, function, process, choice of dosage forms, etc. |
| 2 | Formula | Formula is almost reasonable and it is necessary to further perfect the relevant paper, to provide more literature basis or writing. |
| 3 | Active and inactive ingredients | Active and inactive ingredients quality meets the compliance requirements and it is necessary to further perfect the related materials. |
| 4 | Production process | Production process is almost reasonable and it is necessary to further perfect part of production process. |
| 5 | Product quality standard | The product quality standard meets the basic requirements and it is necessary to be further improved. |
| 6 | Toxicology and function tests | The test projects of toxicology, functions and other tests are complete and the test design is reasonable. The operation meets the basic specification. The test results are convincible. The conclusions almost meet the requirements. It is necessary to perfect the test report format or the content of the test report. |
| 7 | Other tests | Physical indicators, chemical indicators, microbial indicators and other indicators in the test reports meet the current rules. It is necessary to further improve product quality as following the standards of inspection results |
| 8 | Label and instruction |
I, Label and instruction almost meet the compliance requirements and it is necessary to be further improved; II, Product quality and safety almost meet the compliance requirements and it is necessary to change the product name. |
| 9 | Other materials | Applicant qualification certificate, production conditions, notarization materials and other materials need to be further perfected. |
III. CFDA experts will make the conclusion of "Re- technical evaluation after further materials provided" if the registration materials meet the following criteria:
| NO. | Basic Content | Specific Content |
| 1 | The R＆D Report | Research materials of formula, function and process selection or dosage form selection in the R&D reports should be further confirmed to be rational or the registration materials lack the pilot production validation data and the self-test report data. |
| 2 | Formula |
I. The safety or efficacy of formula compatibility is not scientific and reasonable and should be certified and stated again; II. Scientific literatures should be further provided to prove the safety or efficacy of formula compatibility if the safety or efficacy of formula compatibility is confused. |
| 3 | Active and inactive ingredients |
I. Scientific literatures should be further provided to prove the safety or efficacy of raw materials or the intake if the safety or efficacy of raw materials or the intake is confused. II. It is necessary to provide appraisal reports or virulence test reports of some raw materials varieties or bacterial strain; III. Relevant certificates of quality requirements should be further provided if the raw materials quality is confused. |
| 4 | Production process | It is necessary to provide the production process of the main raw material or the detail and integrity production process of products; |
| 5 | Product quality standard |
I. It is necessary to add the technical indexes in the product quality standard and do the stability test of the added technical indexes; II. If some indicators is lacked or unreasonable and It is necessary to provide the clarification again or further offer the clarification; III. It is necessary to provide some raw material quality standards or source certifications. |
| 6 | Toxicology and function tests |
I. Test operation is not standard and it is necessary to redo the acute toxicity test, salmonella typhimurium/mammals microsomal enzyme test (Ames test); II. It is necessary to further provide the toxicology test to evaluate the edible safety. III. It is necessary to provide the toxicology test or function test specification, test data, the scientific literature or other materials to determine whether redo toxicology test or function test. |
| 7 | Other tests |
I. It is necessary to do some test items if product quality retest report is not in conformity with the relevant requirements and the test results cannot be judged. II. It is necessary to further offer the clarification if retest results is in conformity with product quality requirements but exist certain differences with the registration test results to not judge its rationality. III. The referenced test methods in retest reports is not in conformity with the methods in product quality standard and it is necessary to redo the tests according to the product quality standard test methods. |
| 8 | Technical requirements | It is necessary to further revise the product technical requirements. |
| 9 | Other materials | The evaluation experts and the evaluation experts committee consider that the product almost meets the compliance requirements and make the technical evaluation again after applicant supplementing relevant materials. |
IV. CFDA experts will make the conclusion of "Recommended its disapproval" if the registration materials are in the following cases：
| NO. | Basic Content | Specific Content |
| 1 | Production condition | The on-site examined production condition is not in conformity with the Chinese current rules |
| 2 | Authenticity of Submitted registration materials |
I. Some contents of submitted registration materials are not consistent and are hard to ensure authenticity. II. Submitted registration materials are not consistent with the on-site examined contents. |
| 3 | Authenticity of the samples | The samples are inconsistent with submitted registration materials and are hard to ensure authenticity or the quality of samples is unqualified; |
| 4 | Formula | Formula is not reasonable and lacks scientific basis or has safety problems. |
| 5 | Active and inactive ingredients | Active ingredients are beyond the used scope of the current regulation and the ruled relevant materials or the safety and functions materials of the active ingredients cannot be provided. |
| 6 | Production process | Production process is not reasonable. |
| 7 | Dosage form | Product dosage form is not reasonable; |
| 8 | Test |
I. Registration test and product quality retest is not in conformity with the current rules or the test results show that it is difficult to guarantee product quality safety. II. The test results of functional component or symbolic component in test reports are not consistent with the requirements of product quality standard. III. Functional component or symbolic component cannot be tested according to the methods of the product quality standard in the retest reports. IV. Experimental animals are not in conformity with the current rules. V. Test results are not in conformity with the formulation and it is difficult to guarantee the authenticity of formulation and production process. |
| 9 | Other materials | The evaluation experts committee considers that it is hard to ensure product quality and safety. |
"Re-technical evaluation after further materials provided" will lead to repeat queuing to conduct the technical evaluation and evaluation duration will be greatly extended. Therefore, in order to pass CFDA expert technical evaluation and get the registration certificate of dietary supplement more quickly, more attention should be paid on the integrity and authenticity of registration materials before application, additionally, preliminary evaluation is necessary to avoid providing further materials or conducting the Re-technical evaluation.
No matter how the dietary supplement registration regulations change in the future, the key points of dietary supplement registration technical evaluation will not be changed significantly.
Contact us:
Mr. Bob Jiang Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
Email: bob.jiang@cirs-group.com
