Takehome:
- A detailed publication on health food function assessment released by Taiwan FDA will have impact on the registration of health foods in Taiwan
On April 17, 2017, Taiwan FDA released a detailed publication on health food function assessment, which will impact the registration of health foods in Taiwan. The revision mainly includes new requirements related to applicant qualification, inspection materials, examination stage, and request for evidence.
Applicant qualification
According to the second item of article three in Health Food Management Act, the applicant should be an academic research institution.
Inspection materials
The following materials are required for application:
- The application form of health care function assessment
- The proposal of health care function assessment (Readers could contact us for the form and document mentioned above)
Examination stages
Examination involves two stages. The first stage is administrative examination (first trial). The second stage is experimental examination (reexamine).
Request for evidence
During the experimental examination, if other evidence is requested, the applicant should hand on those necessary documents within two months. Supposing that the documents required are not completed within the designated time, the application could be rejected. After replying to the issue of request for evidence raised in the examination stage, the applicant is required to have a meeting for assessment (1 time only). In case the expert examination is disapproved, the applicant could reapply for the examination (1 time only).
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