Health food R&D ideas and registration process in China
date:2016-02-23
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On China Natural Ingredient Conference 2015, Mr. Hu Wenyan, secretary general and standing vice president of China Biochemical Pharmaceutical Industry Association, articulates the R&D thought and registration process of health care foods.
Registration process of health care foods:
1. Confirm the formula, process, quality standard and instructions
2. Produce(by applicant) or entrust to produce samples
3. Sample(specifically implemented by provincial supervision bureau for health care products and cosmetics)
4. Inspection test(physical and chemical hygiene, functional toxicology, human body and excitant)
5. Material arrangement
6. Reporting of pretrial and field check(specifically implemented by provincial supervision bureau for health care products and cosmetics)
7. Recheck test
8. Evaluation(specifically implemented by provincial supervision bureau for health care products and cosmetics)
9. Health Care Foods Approval Certificate(three bureaus of CFDA)
Below is the process flow for R&D and registration of health care products:


Note: health care food imports will go through no sampling link and be directly sent to the inspection institute, with application materials directly submitted to CFDA without submission to the provincial level.
 
I. Confirm the formula, process, quality standard and instructions
Formula principle:
1. Ingredients resource compliant with requirements
Common foods are required to comply with national laws and regulations only, such as the Notice on Further Regularizing Management on Health Care Food Ingredient by the Ministry of Health. Besides, there are specifications on submission and evaluation of fungus health care foods, probiotics health care foods, health care foods made with wild animals and plants, nutritive supplements; identification evaluation and specification of nucleic acid health care product; Hygienic Standard for Use of Food Additives(GB2760); Hygienic Standard for Food Nutrient Enhancer(GB14880); new resource foods as announced by the Ministry of Health; and Management Methods on Review of Safety of New Food Ingredients.
Extracts of the said ingredients are edible.
Some can be listed into the pharmacopeia as minor ingredients without medical effect, such as excipient and filler. Some can also be used as ingredients for health care products as approved, such as melatonin, nucleic acid and coenzyme Q10.
 
2. Ingredient Functions
All ingredients of the formula shall have the functions to be applied by the health care foods or to be fully explained by the TCM theory, as supported by 3 to 5 literatures of scientific research.
 
3. Quantity and Usage of Ingredients
At most14 animal and plant ingredients can be used in a product, with at most 4 listed on the preferential food ingredients and 1 on both lists.
 
4. In Line with Specifications Issued on the Website of CFDA(too Many and Complicated)
 
5. Not be Used as Ingredient for Health Care Foods
Attachment 3(59), Notice on Further Regularizing Management on Health Care Food Ingredient by the Ministry of Health(WSJF No. 51[2002])
 
II. Production Sample(produced by applicant or entrustee)
Samples shall be produced by enterprises of GMP certificate for same dosage form of health care foods or hygiene certificate, by the applicant or the entrusted enterprise qualified.
 
III. Sampling
1. Sampling Process
Applicants shall first prepare the record of production batch and relevant production files as prepared by GMP certification. Qualified samples shall be put in storage. Application form for registration, inspection and sampling of health care foods, sampling form for registration and inspection of health care foods, and authorization for production commissioning shall be filled out.
Sealed application form for registration, inspection and sampling of health care foods and filled-out sampling form for registration and inspection of health care foods in paper or electronic version shall be submitted to the provincial bureau of health care products and cosmetics to gain the sampling number.
Provincial Bureau of Health Care Products and Cosmetics shall sample on site, seal the strip, collect the quantity of samples produced, seal and finish the sampling.
 
2. Sampling Precautions
Quantity of samples shall be in line with the inspection demand. Communication is needed in advance with the inspector for the quantity of samples needed. In particular, treatment and quantity of samples with toxicological function shall be confirmed, otherwise additional sampling is unavailable. Different inspectors have different requirements on sample quantity.
Batches for trial production and usage of samples shall be born in mind, as well as the quantity of self-inspection, submission and remaining samples. The quantity must be the same with that of the onsite examination.
Relevant documents of official seal shall be stored.
IV. Inspection Test(Physical and Chemical Hygiene, Functional Toxicology, Human Body and Excitant)
1. Submit for inspection
Application form for registration, inspection and sampling of health care foods, sampling form for registration and inspection of health care foods shall be prepared, and submitted to the inspector institute together with the formula, process, quality standard, instruction and sample. The inspector institute shall provide notice of sample acceptance.
 
2. Inspection
Nowadays, inspection of health care foods normally needs 1 to 2 year(s). Enterprises have nothing to do but wait.
 
V. Material Arrangement
Application materials:
 1. Application for Registration of Domestic Health Care Foods
2. Photocopy of legal registration document of the applicant
3. Retrieval material for health care foods with different generic names with medicines approved for registration
4. Guarantee of non-infringement to other patents of the applicant
5. Trademark registration certificate
6. Product R&D report
7. Product formula and formula reference, source and use reference of ingredient and accessory
8. Iconic components, content and inspection method for iconic components
9. Production process diagram, detailed instruction and relevant research materials
10. Products’ quality standard and preparation instruction
11. Type, name, quality standard and selection reference of package materials in direct contact with products
12. Inspection report issued by inspection institute
12.1 Safety toxicology experiment report
12.2 Animal function test report
12.3 Test report for trial eating by human body
12.4 Excitant inspection report
12.5 Iconic component inspection, stability test, and hygienic test report
13. Drafts of product labeling and instructions
14. Technical requirement for health care foods and products, and confirmation form submitted
15. Other materials helpful for product approval
15.1 Legal registration document of ingredient manufacturer
15.2 Ingredients and accessories inspection report
15.3 Evidence of ingredients and accessories source
15.4 Business license and hygienic permission of trial producer
15.5 Other literatures
16. 2 pieces of sealed minimum sales packaged samples
 
VI. Pretrial Submission and Onsite Inspection
Pretrial
The said materials shall be prepared, with a photocopy submitted to the provincial bureau of health care products and cosmetics for preliminary review, and proposal of modification opinions for those non-conforming ones and notice to those qualified to submit formal materials.
 
Report
1. 1 original copy and 8 photocopies of registration of new products and re-registration shall be submitted. 1 original copy is needed for application for registration of products modification and technical transfer. Photocopy shall be utterly the same with original copies, copied from original copies and kept complete and clear.
2. Authorized power of attorney and soft disk
3. Provincial bureau of health care products and cosmetics shall undergo formal examination, with notice of acceptance of health care foods issued for those qualified.
 
Content of Field Inspection
1. Field investigation of sample agents
2. Site inspection of sample inspection
 
VII. Review Inspection
Review inspection refers to the review on sensory requirement, physical and chemical index, functional component, microorganic index of iconic component, net content and allowed deviation of the quality standard applied by the applicant as different as required by the inspector institute.
Review inspection is entrusted to the provincial food and drug administration, which is responsible for submitting the filled-out Notice on Inspection of Health Care Foods and the samples to the inspector institute, and signing the Inspection Agreement.
The applicant is responsible for the expense and specific work.
The review inspection report is directly submitted to the Health Care Food Review Center, CFDA by the inspector institute.
A key factor in the review inspection is that great inconsistency between the inspection results and results of registered inspection will directly disapprove the products.
 
VIII. Examination
Examination shall be specifically implemented by the Health Care Food Review Center, CFDA
1. The evaluation meeting shall be held monthly, principally falling on the last week of each month
2. The meeting normally lasts for about a week
3. Experts shall be selected at random to make up the evaluation panel, consisting of enormous evaluation teams, with the chairman or vice chairman serving also as the evaluation director
4. The evaluation is carried out by each team, with the director in charge of his/her team
5. Experts shall review the application materials in the mornings and carry out collective review in the afternoons
The evaluation process is shown below:
 
Conclusion of technical evaluation for health care foods:
Evaluation conclusion 1: approval recommended
Evaluation conclusion 2: approval recommended when materials supplemented
Evaluation conclusion 3: re-evaluation on the meeting when materials supplemented
Evaluation conclusion 4: disapproval recommended
Evaluation conclusion 5: re-evaluation put off
 
IX. Health Care Foods Approval Certificate
Health care foods approval certificate issued by the three bureaus of the CFDA
 
Conclusion
As far as the author knows, the registration process for health care foods is quite complicated. However, through the detailed introduction of Secretary General Hu, we feel quite easy to understand. In the author’s opinions, it’s not difficult to get the certificate if the enterprise acts in strict compliance with the regulations to make quality, authentic products.
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