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Improving review mechanism to accelerate licensing process of "health food"

  • Data Source：Food and Drug Administration, Ministry of Health and Welfare
  • Created：2021-12-16
  • Last Updated：2021-12-16

The Ministry of Health and Welfare issued the amendment to "Regulations for Application of Health Food Permit", in 2020, relating to the submission of supplementary documents as well as information throughout the preliminary and secondary reviews process. The  newly added provisions include the mode of relief, the mechanism of administrative reconsideration petition, the on-site inspection if necessary, and optional application of product analysis along with case review simultaneously. The amendments aim to improve the quality of application submission and review efficiency based on scientific evidence, in hope that the license of "health food" of high quality can be issued as soon as possible to further benefit consumers.

To be more specific, the period of time for applicant to submit supplementary documents following either preliminary or secondary reviews is shortened from two months to one month. The applicant will be allowed to provide the required documents for one time. With regards to the mode of relief, the administrative reconsideration petition can be filed within six months for the dismissed cases after either preliminary or secondary reviews. Furthermore, the on-site inspection may be conducted by central competent authority during the process of reviewing as necessary. To shorten time and promote the efficiency for case reviews, product analysis can synchronously be applied to carry out while the documental reviews is under way.

The Food and Drug Administration of the Ministry of Health and Welfare continues to strengthen the consultation and provide assistance for the health food industry during the application for health food registration including holding several briefing sessions annually, providing consultation services to assist businesses in technical and regulatory issues, which will help case review smoother and more transparent. The information for consultation service can be inquired on the official website of the Food and Drug Administration of the Ministry of Health and Welfare (http://www.fda.gov.tw/ENG/index.aspx; Home > Food > Registration > Health Food).