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China,Health,Food,Dosage,Form,Filing,Registration

At present, only 5 dosage forms are available for health food filing in China: tablet, hard capsule, soft capsule, oral liquid and granule. On August 28, SAMR issued the Technical Requirements for the Health Food Filing of Powder (2020 version) (Draft) and Technical Requirements for the Health Food Filing of Gelatin Candy (2020 version) (Draft), and revised the Available Excipients for Health Food Filing and Their Usage Rules (2020 version) (Draft) and Dosage Forms and Main Production Process of Health Food Filing (2020 version) (Draft). The deadline for public comments is September 28, 2020.

The release of the four drafts means that gelatin candy (gummies) and powder will be the available dosage forms of filing products in China in the near further.

Gelatin Candy (Gummies)

1) Key information for the filing of gummies

Items	Related Requirements
Suitable Crowds	People over 4 years old
Daily Intake	The daily intake shall be ≤20g.
Specification	The weight of per candy shall be ≤6g
Notes	I. People who take the product shall have the ability to chew solid food. II. If the product is suitable for the people under 13 years old, it is recommended to add the reminder of “taken under the supervision of adult”.
Main Production Process of Gummies	Including melting the gel, melting the sugar, boiling, blending, filtering, inflating, molding, drying, mixing sand, coating, polishing, smearing, packaging, etc.

2) The available excipients for gummies

Currently, 196 kinds of excipients are available for health food filing. As gummies is a kind of food, the available excipients are less than other dosage forms (such as capsules, tablet, granule). Therefore, SAMR revised the Available Excipients for Health Food Filing and Their Usage Rules. According to the drafted Excipients Directory, only 152 kinds of excipients can be used for the production of gummies. Excipients such as iron oxide black, iron oxide red, iron oxide yellow, dextrin, silicon dioxide, fumaric acid, monascus yellow pigment, etc., are not allowed for gummies.

Powder

1) Key information for the filing of powder

Items	Related Requirements
Suitable Crowds	All people
Daily Intake and Directions	I. The daily intake shall be ≤20g. II. The reminder of "powder is generally dissolved or dispersed in water or other liquids before taking, and it can also be taken directly with water" shall be indicated. III. If the intake direction is taking orally directly, the unsuitable crowds should include the people under 6 years old.
Specification	For megadose packages, each package is limited to no more than 500g (no more than one month's dosage in principle). Megadose packaging should be accompanied by sub-packing utensils.
Main Production Process of Powder	Including crushing, sieving, mixing, sub-packaging, packaging, etc.

2) The available excipients for powder

Similar to gummies, the excipients that can be used for powder are also clarified in the Excipients Directory (Draft). 172 excipients in total can be used for the production of powder. And excipients such as iron oxide black, iron oxide red, iron oxide yellow, dextrin, etc., are not allowed for powder.

Influence and suggestions

Due to the limited dosage forms, many nutrition supplements cannot apply for health food filing, even though their product formulas are compliant under the requirements of health food filing. As we know, gummies and powder are popular dosage forms for nutrition supplements at home and abroad, therefore, once they get the final approval for health food filing, a great number of nutrition supplements under these dosage form can apply for health food filing in China.

For relevant enterprises interested in Chinese market, it is recommended to carry out some preparations in advance, such as formula feasibility analysis, health food filing system account application (for new filing applicant), etc. Once the new dosage forms are officially approved, you can start the filing application as soon as possible, and gain advantage over other opponents in Chinese market.

If you have any needs or questions, please contact us at service@jianzaoshiwang.cn.

Reference:

SAMR Notice

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Gelatin Candy (Gummies) and Powder will be the Available Dosage Forms of Health Food Filing in China