On February 20, 2021, the SAMR (State Administration of Market Regulation) published (No.7-2021) the Dosage Forms of Health Food and Technical Requirements for Filing (2021 Edition) and the List of Excipients for Health Food Filing and Terms of Use (2021 Edition) with effect from June 1, 2021 onwards.
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.
List of Excipients for Health Food Filing and Terms of Use (2021 Edition)
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.
