Description of Review Process
- Last updated：2024-12-31
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Health food registration review adopts a dual-track system: the first track is individual case review, and the second track is standard specification review. Since July 1, 2015, the first track (individual case review) has been divided into two stages: "preliminary review" and "secondary review".
- After an applicant submits documents to the TFDA Food Safety Division, a project manager from the CDE handles administrative operations and forms an internal review team including reviewers for health care effect assessment, safety, and stability. The review is conducted according to "The Flowchart of Application for Health Food Permit".
- In the preliminary stage of the first track, the review team checks administrative documents and technical dossier items, completes a preliminary review report, and eliminates non-compliant cases that violate food safety and hygiene regulations (e.g., exceeding limits and standards for food additives).
- In the secondary review stage of the first track, in addition to the CDE reviewers providing secondary review evaluations on study reports, Health Food Review Committee members are also included in the review process. After setting the date of the Health Food Review Committee meeting, the project manager consolidates the opinions of all committee members and then communicates the review opinions to the applicant; written responses to the review opinions must be submitted before the meeting. Meeting members include the CDE's project manager, reviewers, Health Food Review Committee members, and representatives from the TFDA Food Safety Division and Research and Analysis Division. The chairman of the meeting summarizes the meeting resolutions, and the project manager records the minutes, issues inquiries based on the meeting minutes, and handles subsequent product analysis.
- The second track (standard specification review) involves a quality check of the submitted product data. After the quality check is passed, it is sent to the TFDA Research and Analysis Division for verification of functional components. If necessary, the Health Food Review Committee meeting is convened for review.