On July 27, 2017, Guangdong FDA issued the filing information of “SUNOTA Folic Acid Tablets” (善元堂牌叶酸片), which is the first filed domestic health food since the Administration Measures on Heath Food Registration and Filing came into force on July 1, 2016. The filing applicant is Guangzhou SUNOTA Health Technology Co., Ltd and the first filing number is “食健备G201744000001”.
According to the filing materials opened to the public, there are two major attractions.
1. The filing can be completed within 3 working days
The date in Health Food Filing Record Form is July 12, 2017, and the date on filing certificate is July 17, 2017. It shows that after submitting all the required filing materials, the enterprise can obtain the filing certificate in 3 working days.
2. Submitting self-test report and CMA certification body report can help to enhance the efficiency of application
Among the test reports of “SUNOTA Folic Acid Tablets”, the all-item test report of technical requirements is issued by CMA certification body, while the stability test report is issued by the enterprise itself. It greatly shortens the time for issuing test reports and can improve the efficiency of application obviously. In the past when there was only health food registration, all the test reports should be issued by the 58 inspection agencies designated by CFDA, and the choices could be very limited.
Health food filing is much easier than health food registration. As the first filing number has been given out, CIRS thinks that more health food filing certificates will be issued in the following periods. For information about the health food filing, please kindly click here, which will help you better understand the health food filing requirements.
If you have any needs or questions, please contact us at service@cirs-group.com.
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