An international company located in USA would like to export her Aqueous Extract of Seed of Broccoli to Taiwan as a functional ingredient in foods/supplements.

It was found that the unique ingredient needs to be approved from TFDA since the ingredient is not allowed traditional food ingredient in Taiwan.

The company, therefore, consigned SCG for gap analysis for whether the safety assessment documents are enough or not for the first step. Couple documents had been recommended to amend the gap.

At the second stage (after the amended documents were ready), the company continued to consign SCG to prepare the dossier in Chinese to apply to TFDA. Though the whole reviewal process by TFDA was delayed due to the COVID-19 epidemic, no additional document was required by the TFDA committee and experts. Eventually, TFDA published the approval on the 8th June, 2023 officially. It is time for the company for setting up the marketing plan in Taiwan now.

Why there was no additional amendment/revision document required by TFDA officers?

Because,

1. SCG had pay enough attention at the first beginning during the gap analysis.
2. SCG team member(s) is(are) rigorous on inspection, review, question clarification and preparation process.
3. SCG focused on scientific logics of all documents and statements on application dossier preparation.

The attention, rigorous attitude, focus and professional knowledge of SCG team will result in the reliability and trust from the clients. All clients finally found the consignment is worthy.

https://www.e-sinew.com/site/EN/TFDA/Novel_Ingredient.php

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