According to the health food filing regulations in China, currently, only 5 dosage forms are allowed for health food filing products, but gelation candy (gummies) is not included. Recently, it is reported that a demonstration report concerning adding the dosage form of gelation candy into health food filing system has been submitted to former CFDA Health Food Review Center. And the former CFDA Heath Food Review Center is now considering adding this dosage form.
The allowed dosage forms of health food filing
At present, the 5 dosages forms allowed for health food filing in China and their main production processes are as follows.
|
Allowed dosage forms |
Details |
Main processes |
|
Tablet |
Tablet, buccal tablet, chewable tablet, effervescent tablet |
Crushing, sieving, mixing, granulation, drying, tableting, coating, packaging, etc. |
|
Granule |
Granule |
Crushing, sieving, mixing, granulating, drying, packaging, etc. |
|
Oral liquid |
Oral liquid, drops |
Mixing, dissolving, preparation, filtration, filling, packaging, etc. |
|
Hard capsule |
Hard capsule |
Crushing, sieving, mixing, granulation, drying, capsule filling, packaging, etc. |
|
Soft capsule |
Soft capsule |
Drying, mixing, homogenizing, filtration, capsule pressing, packaging, etc. |
Influence and suggestion
Due to the limited dosage forms, many nutrition supplements cannot apply for health food filing, even though their product formula are compliant under the requirements of health food filing. As we know, gelation candy is one of the most popular dosage forms for nutrition supplements at home and abroad, therefore, once gelatin candy get the final approval for health food filing, a great number of nutrition supplements under this dosage form can apply for health food filing in China.
For relevant enterprises interested in China 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 gelation candy is officially approved, you can start the filing application as soon as possible.
If you have any other needs or questions, please feel free to contact us via service@cirs-group.com.
