Administrative Measures for the Registration and Recording of Dietary Supplements
Administrative Measures for the Registration and Recording of Dietary Supplements
Administrative Measures for the Registration and Recording of Dietary Supplements
Order of China Food and Drug Administration No.22
February 26, 2016
The Administrative Measures for the Registration and Recording of Dietary Supplements, which was adopted at the Executive Meeting of the China Food and Drug Administration ("CFDA") on February 4, 2016, is hereby promulgated for implementation as of July 1, 2016.
Bi Jingquan, Minister of China Food and Drug Administration
Administrative Measures for the Registration and Recording of Dietary Supplements
Chapter I General Provisions
Article 1 In order to standardize the registration and recording of dietary supplements, the Administrative Measures for the Registration and Recording of Dietary Supplements ("these Measures") are hereby promulgated in accordance with the Food Safety Law of the People's Republic of China ("Food Safety Law").
Article 2 These Measures apply to the registration and recording as well as supervision and administration of dietary supplements within the territory of the People's Republic of China.
Article 3 For the purposes of these Measures, the registration of dietary supplements refers to the process that the food and drug authorities, pursuant to statutory procedures, criteria and requirements, conduct a systematic evaluation and review of relevant registration application documents of dietary supplements in respect of safety, health functions and quality controllability and make a decision on approving or rejecting registration.
The recording of dietary supplements refers to the process that a dietary supplement manufacturer, pursuant to statutory procedures, criteria and requirements, submits the documents of a product evidencing its safety, health functions and quality controllability to the food and drug authorities for record, disclosure or future reference.
Article 4 The registration and recording as well as supervision and administration of dietary supplements shall be conducted in a scientific, open, fair, convenient and efficient manner.
Article 5 The CFDA shall be responsible for administering the registration of domestic dietary supplements and the recording of firstly imported dietary supplements that provide nutrients such as vitamins and minerals, as well as for guiding and supervising the food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government for their works related to dietary supplement registration and recording.
The food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for administering the registration of dietary supplements within their respective jurisdictions and assisting the CFDA in onsite inspection for dietary supplement registration or other works.
The food and drug authorities at the city or county level shall be responsible for supervising and administering the dietary supplements registered and recorded within their respective jurisdictions and undertaking other works assigned by the food and drug authorities at higher level.
Article 6 The administrative accepting service institution of the CFDA ("Accepting Institution") shall be responsible for accepting registration applications of domestic dietary supplements and receiving the recording documents of imported dietary supplements.
The food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for receiving the recording documents of relevant dietary supplements.
The evaluation institution of the CFDA ("Evaluation Institution") shall be responsible for organizing evaluation of dietary supplements, administering evaluation experts and undertaking the relevant recording works as required by law.
The inspection institution of the CFDA ("Inspection Institution") shall be responsible for conducting onsite inspection for dietary supplements to be registered.
Article 7 Dietary supplement registration or recording applicants shall have the required expertise and have a good understanding of the laws, regulations, rules and technical requirements regarding dietary supplement registration.
Dietary supplement registration or recording applicants shall ensure the authenticity, completeness and traceability of the application documents submitted and assume the legal liability for the authenticity of such documents.
Dietary supplement registration or recording applicants shall assist the food and drug authorities in carrying out onsite inspection, sampling, retesting, supervision and administration relating to dietary supplement registration or recording.
Article 8 The food and drug authorities at or above the provincial level shall strengthen IT development, raise the IT application in administration over dietary supplement registration and recording and achieve e-registration and e-recording step by step.
Chapter II Registration
Article 9 Manufacturing or importation of the following dietary supplements shall be subject to registration:
1. dietary supplements using raw materials beyond the raw materials catalogue for dietary supplements ("Non-catalogue Raw Materials");
2. firstly imported dietary supplements, excluding those that provide nutrients such as vitamins and minerals.
For the purposes of these Measures, firstly imported dietary supplements refer to dietary supplements which are applied for marketing within China but manufactured using different formulas by different manufacturers in different countries.
Article 10 The health functions claimed shall have been included in the function claim catalogue for dietary supplements.
Article 11 Applicants for registration of domestic dietary supplements shall be legal entities or other organizations incorporated within China. Applicants for registration of imported dietary supplements shall be overseas manufacturers of marketed dietary supplements.
Application for registration of imported dietary supplements shall be filed by the applicant's representative office in China or the domestic agency authorized by it.
For the purposes of these Measures, an overseas manufacturer refers to a legal entity or other organization whose products meet local marketing requirements.
Article 12 The following documents shall be submitted when applying for registration of a dietary supplement:
1. application form and letter of commitment on the legal liability for the authenticity of application documents;
2. copy of the business license of the applicant;
3. research report of the product, including researchers, research period and process, data from pilot or larger scale production; analysis and relevant scientific ground for the safety, health functions and quality controllability of non-catalogue raw materials and the product; technical requirements of the product derived from research results;
4. formula description, including the name, dosage, manufacturing process and quality standards of raw and auxiliary materials. If necessary, the basis for using such raw materials, the specific part used, inspection certificate and variety identification report shall be furnished as required;
5. description of manufacturing process of the product, including flowchart and instructions as well as critical control points and instructions;
6. evaluation of safety and health functions, including evaluation of safety, health functions and human consumption testing of non-catalogue raw materials and the product; testing reports of functional/key ingredients, hygiene, stability, microbial identification and strain virulence; stimulant and illicit drug testing reports;
7. type, name and relevant standards of immediate packaging materials;
8. sample of label and instructions; retrieval documents proving the generic name of the product is different from registered drug names;
9.
......
Order of China Food and Drug Administration No.22
February 26, 2016
The Administrative Measures for the Registration and Recording of Dietary Supplements, which was adopted at the Executive Meeting of the China Food and Drug Administration ("CFDA") on February 4, 2016, is hereby promulgated for implementation as of July 1, 2016.
Bi Jingquan, Minister of China Food and Drug Administration
Administrative Measures for the Registration and Recording of Dietary Supplements
Chapter I General Provisions
Article 1 In order to standardize the registration and recording of dietary supplements, the Administrative Measures for the Registration and Recording of Dietary Supplements ("these Measures") are hereby promulgated in accordance with the Food Safety Law of the People's Republic of China ("Food Safety Law").
Article 2 These Measures apply to the registration and recording as well as supervision and administration of dietary supplements within the territory of the People's Republic of China.
Article 3 For the purposes of these Measures, the registration of dietary supplements refers to the process that the food and drug authorities, pursuant to statutory procedures, criteria and requirements, conduct a systematic evaluation and review of relevant registration application documents of dietary supplements in respect of safety, health functions and quality controllability and make a decision on approving or rejecting registration.
The recording of dietary supplements refers to the process that a dietary supplement manufacturer, pursuant to statutory procedures, criteria and requirements, submits the documents of a product evidencing its safety, health functions and quality controllability to the food and drug authorities for record, disclosure or future reference.
Article 4 The registration and recording as well as supervision and administration of dietary supplements shall be conducted in a scientific, open, fair, convenient and efficient manner.
Article 5 The CFDA shall be responsible for administering the registration of domestic dietary supplements and the recording of firstly imported dietary supplements that provide nutrients such as vitamins and minerals, as well as for guiding and supervising the food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government for their works related to dietary supplement registration and recording.
The food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for administering the registration of dietary supplements within their respective jurisdictions and assisting the CFDA in onsite inspection for dietary supplement registration or other works.
The food and drug authorities at the city or county level shall be responsible for supervising and administering the dietary supplements registered and recorded within their respective jurisdictions and undertaking other works assigned by the food and drug authorities at higher level.
Article 6 The administrative accepting service institution of the CFDA ("Accepting Institution") shall be responsible for accepting registration applications of domestic dietary supplements and receiving the recording documents of imported dietary supplements.
The food and drug authorities of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for receiving the recording documents of relevant dietary supplements.
The evaluation institution of the CFDA ("Evaluation Institution") shall be responsible for organizing evaluation of dietary supplements, administering evaluation experts and undertaking the relevant recording works as required by law.
The inspection institution of the CFDA ("Inspection Institution") shall be responsible for conducting onsite inspection for dietary supplements to be registered.
Article 7 Dietary supplement registration or recording applicants shall have the required expertise and have a good understanding of the laws, regulations, rules and technical requirements regarding dietary supplement registration.
Dietary supplement registration or recording applicants shall ensure the authenticity, completeness and traceability of the application documents submitted and assume the legal liability for the authenticity of such documents.
Dietary supplement registration or recording applicants shall assist the food and drug authorities in carrying out onsite inspection, sampling, retesting, supervision and administration relating to dietary supplement registration or recording.
Article 8 The food and drug authorities at or above the provincial level shall strengthen IT development, raise the IT application in administration over dietary supplement registration and recording and achieve e-registration and e-recording step by step.
Chapter II Registration
Article 9 Manufacturing or importation of the following dietary supplements shall be subject to registration:
1. dietary supplements using raw materials beyond the raw materials catalogue for dietary supplements ("Non-catalogue Raw Materials");
2. firstly imported dietary supplements, excluding those that provide nutrients such as vitamins and minerals.
For the purposes of these Measures, firstly imported dietary supplements refer to dietary supplements which are applied for marketing within China but manufactured using different formulas by different manufacturers in different countries.
Article 10 The health functions claimed shall have been included in the function claim catalogue for dietary supplements.
Article 11 Applicants for registration of domestic dietary supplements shall be legal entities or other organizations incorporated within China. Applicants for registration of imported dietary supplements shall be overseas manufacturers of marketed dietary supplements.
Application for registration of imported dietary supplements shall be filed by the applicant's representative office in China or the domestic agency authorized by it.
For the purposes of these Measures, an overseas manufacturer refers to a legal entity or other organization whose products meet local marketing requirements.
Article 12 The following documents shall be submitted when applying for registration of a dietary supplement:
1. application form and letter of commitment on the legal liability for the authenticity of application documents;
2. copy of the business license of the applicant;
3. research report of the product, including researchers, research period and process, data from pilot or larger scale production; analysis and relevant scientific ground for the safety, health functions and quality controllability of non-catalogue raw materials and the product; technical requirements of the product derived from research results;
4. formula description, including the name, dosage, manufacturing process and quality standards of raw and auxiliary materials. If necessary, the basis for using such raw materials, the specific part used, inspection certificate and variety identification report shall be furnished as required;
5. description of manufacturing process of the product, including flowchart and instructions as well as critical control points and instructions;
6. evaluation of safety and health functions, including evaluation of safety, health functions and human consumption testing of non-catalogue raw materials and the product; testing reports of functional/key ingredients, hygiene, stability, microbial identification and strain virulence; stimulant and illicit drug testing reports;
7. type, name and relevant standards of immediate packaging materials;
8. sample of label and instructions; retrieval documents proving the generic name of the product is different from registered drug names;
9.
......