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.
Gelatin Candy (Gummies)
The daily intake shall be ≤20g.
The weight of per candy shall be ≤6g
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.
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.
Daily Intake and Directions
III. If the intake direction is taking orally directly, the unsuitable crowds should include the people under 6 years old.
Main Production Process of Powder
Including crushing, sieving, mixing, sub-packaging, packaging, etc.
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.
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