Dosage Forms of Health Food and Technical Requirements for Filing (2021 Edition)
In order to expand the scope of dosage forms of health food, the SAMR announced the draft on August 25, 2020 to solicit public comments.
In the finalized version (2021 Edition), powder and gelatinized candy will be considered new health food dosage forms for filing. The SAMR addressed the technical requirements for both products in the annexes.
The SAMR announced the list of excipients approved for health food filing and the corresponding requirements such as the usage limits for solid form and liquid form, and the related standard.
By Jacky Li. Contact Cisema if you would like to learn more.