How to register new food ingredient in Taiwan TFDA?

We provide you the TFDA Food Registration services relevant to Products in Tablet or Capsule Form, Health Food, Food Additive, Special Dietary Food, Genetically Modified Food.

Send an email to tpe4ww.elr@evershinecpa.com
Director Jerry Chu, USA Graduate School Alumni, and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103

HLF-Tw-010
How long does it usually take for TFDA to register after submitting it?
It would be better if you can let me know about the entire process of the registration.

Answer:
Registration Process and Timeline
The registration process for a new food ingredient with the Taiwan Food and Drug Administration (TFDA) typically involves several steps:
1.Preparation of Documentation:
Gather all necessary documents, including safety data, toxicity studies, and other relevant information.
2.Submission of Application:
Submit the application along with the required documents to TFDA.
3.Review and Evaluation:
TFDA reviews the submitted documents. This stage may involve requests for additional information or clarification.
4.Approval and Registration:
Once the review is complete and the ingredient is deemed safe, TFDA will issue a registration certificate.

The entire process can take several months, typically around 6 to 12 months, depending on the complexity of the ingredient and the completeness of the submitted documentation.

https://www.fda.gov.tw/eng/site.aspx?sid=10172

HLF:tw-020
Can we submit as English version? If only Chinese documentation is accepted, could you provide the translation service from English to Chinese? If only Chinese documentation is accepted, could you provide the translation service from English to Chinese?

Answer:
Documentation Language
TFDA generally requires documentation to be submitted in Chinese.
While some parts of the application can be in English, key documents such as the application form, cover letter, and any patient-facing documents must be in Chinese.
https://www.fda.gov.tw/eng/Site.aspx?sid=10165
If you need translation services from English to Chinese, Evershine colleagues can help that for you.

HLF-tw-030
We confirmed that it must be submitted by the importer in Taiwan. Is this correct?
Client does not have any importers in Taiwan yet, can they submit you as an applicant?
If possible, please let us know your service fee.
In addition, could you explain the details of the change notification if they have an importer after registration?

Answer:
Yes, the application must be submitted by an importer based in Taiwan.
If your client does not have an importer in Taiwan, they cannot submit the application directly.
However, you can work with a local agent or service provider to act as the applicant on their behalf.
Regarding service fees, it would be best to contact a local regulatory consultant or service provider for a detailed quote. If you need assistance finding one, I can help with recommendations.
For change notifications after registration, if your client appoints a new importer, they must notify TFDA and update the registration details accordingly.
This process involves submitting a change notification form along with the relevant documentation.

HLF-tw-040
Toxicity studies
Are all of the studies below required? As mentioned above, this ingredient is already registered in the US and EU.
[Genotoxicity study (Reverse mutation test, Micronucleus Test, Mammalian chromosomal aberration test), Single oral dose toxicity study, Repeated oral dose toxicity study (4 weeks & 13 weeks), Teratology study, Generation reproductive study, Carcinogenesis study]
They already evaluated for Genotoxicity studies, Single & Repeated oral dose toxicity studies, and Clinical study according to OECD guidance.
Is additional study required?
Does TFDA recognize studies conducted in accordance with OECD guidance? Or do they need to conduct the study again at a testing agency in Taiwan? If they have to conduct the studies again in Taiwan, could you provide the service to arrange with accredited testing agency? Can you provide this service?

Answer:
Toxicity Studies
TFDA requires comprehensive toxicity studies for new food ingredients. The studies you mentioned are generally required:

Genotoxicity studies (Reverse mutation test, Micronucleus Test, Mammalian chromosomal aberration test)
Single oral dose toxicity study
Repeated oral dose toxicity study (4 weeks & 13 weeks)
Teratology study
Generation reproductive study
Carcinogenesis study

Since the ingredient is already registered in the US and EU, TFDA may accept existing studies if they comply with OECD guidelines. However, TFDA may still require additional studies or local data to ensure safety for the Taiwanese population.
If additional studies are needed, they must be conducted at an accredited testing agency in Taiwan.
We can assist in arranging these studies with a local accredited agency if required.

Contact Us

If you are interested in our services,
please send an email to tpr2ww.elr@evershinecpa.com.
We will respond to you in 1-2 working days.

You may also call in working hours (Taipei and China Time):
Director Jerry Chu, USA Graduate School Alumni and a well-English speaker
Mobile: +886-939-357-735
Tel No.: +886-2-2717-0515 ext. 103

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(version: 2024/07)

(version: 2024/07)

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