What documents are needed when submitting a functional ingredient application to the MFDS?
How should human testing be conducted?
Let’s examine the relevant Korean regulations.
Regulation on Recognition of Functional Ingredient and of Standard·Specification for Health Functional Foods
[Enforcement Date July 29, 2021]
[Public Notice of the Ministry of Food and Drug Safety No. 2021-66, July 29, 2021]
The term “human study” means an experiment conducted on humans to demonstrate the safety and effectiveness of functional ingredients.
Article 14 (Details and requirements for submission documents)
8. Data for health claims:
a. Health claims:
An applicant shall state the useful effect on health by consuming the relevant ingredient;
b. An applicant must submit data from human studies, animal experimentation, in vitro
experimentation, etc., as data on effectiveness:
1) An applicant must submit intervention study or observational study data for human studies.
Among intervention studies, a randomized controlled trial (double-blind) designed trial is desirable, and the results must be universally applied to the public;
4) Human studies must be approved by the Institutional Review Board (IRB) on Human Studies according to the Guideline for Good Clinical Practice by International Conference on Harmonization (ICH GCP), and one of the following detailed list must be submitted.
1) Human study protocol and final report;
2) It must be published (including publication certificate) in academic journals equivalent to or higher than SCI, including SCI(E), or KCI: Provided, That in cases of submission as articles published in an academic journal, submission of a human study protocol and final report may be requested.
What documents are needed when submitting a functional ingredient application to the MFDS?
**Answer: Human study protocol and final report, Institutional Review Board (IRB) approval documents.
How should human testing be conducted?
**Answer: Approved by the Institutional Review Board (IRB) on Human Studies according to the Guideline for Good Clinical Practice by International Conference on Harmonization (ICH GCP)
You have standardized raw materials and measured efficacy through human testing.
Now, you want to come to Korea, display health claims, obtain approval, and sell them.
Contact us, and we will secure approval for you.
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