The New Guidance of Dietary Supplement Registration in China 2015

NO.

Registration required materials

The differences between the law in 2015 and in 2005, and relevant comments.

1

The application form of dietary supplement registration

No big change.

2

The originals and copies of legal registration document of registrants.

No big change.

3

Retrieval information (retrieved from CFDA government website database) proving that the generic names of the dietary supplement being applied don’t overlap with the names of products already registered

No big change.

4

R&D materials of products

R&D materials of products were replaced as more completed and scientific R&D data reports. This change demonstrated that Chinese governments inclined to pay more attention to the safety, scientificity and functionality of product formula.

5

Product formula materials

The new law requires that the product formula materials should include the qualification and survey report of raw materials. CIRS advises that foreign manufacturer of dietary supplement should be more familiar with the standards of quality, variety and dosage of raw materials that formulated by Chinese governments.

6

Product process materials

Product process materials should include the variety, name, quality standards and choosing basis of packing material of direct contact product. This change showed that foreign manufacturer of dietary supplement should research the product quality stability in shelf life.

7

Materials of product safety and function evaluation.

Materials of product safety and function evaluation were added the consumption evaluation, the specific methods and detailed description of reevaluation test of product safety and healthcare function (pretreatment method and inspection periods of samples should be clear) and related research materials. This change showed that Chinese government will be more stringent to the testing methods and result of product toxicological security and function.

8

Technical requirement of products.

The requirements of product technologies were added that the key process control points, standard and source of raw materials, detailed description and related research materials. This change showed that Chinese governments pay more attention to the manufacturer’s research on the product process, quality standards, and examination to raw materials supplier.

9

Product labels and manual sample

The new guideline of dietary supplement labels has many changes, which showed that Chinese governments will be stricter to the requirements of the unsuitable crowds, attentions and label formats of dietary supplement.

10

Symposium of comprehensive analysis on product safety, healthcare functions and quality controllability and related scientific basis.

Symposium was the newly added item in the Measure. From now on, the registrant of dietary supplement need to generalize and summarize the toxicology testing report, healthcare functions report and product R&D report.

11

Three unopened minimum-packing samples in shelf life.

The previous law needs only two samples. The new law requires three.

12

Other materials that may help product registration.

No big change.

NO.

The additional materials that required for imported dietary supplement registration

The differences between the law in 2015 and in 2005, and relevant comments.

1

The certificates which demonstrate that the registrant is the legal possessor of the product. The certificates should be issued by the countries or regions where manufacturer belong to and have the valid period on it.

The new law added the report of safety situation of selling and consumption. If a product has a good sale in overseas and has no any safety problem, it would be much helpful to its registration in China.

2

The certificate which certifies that this product has been on sale for more than 1 year. This certificate should also be issued by original country.

3

The certificate which certifies that manufacturer meets the local quality management standards. This certificate should be issued by original country and have the valid period on it.

4

The analyzing report about the sales and the consumption situation in original country.

5

The package, labels and manual samples of the product in original country or region.

6

The product-related standards from original country or international organizations.

7

Three conductive batches of on sale products or specially treated samples which used in review testing. The number is triple to the quantity needed by testing.

Notes: All foreign language materials provided by manufacturers need to be translated into Chinese. And Chinese document should be notarized by Chinese notary department. The certificates provided by foreign institutes should be notarized by local notary department and need to be confirmed by Chinese Embassy. The product quality standards (Chinese version) have to be in line with the format of Chinese quality standards of dietary supplement.