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Science and Research
Testing Service and Process
Science and Research
Testing Service and Process
【Update Date:
2018-10-17
】
unit:研究檢驗組
Testing Service and Process
Firms that manufacture or import medicine and/or specific food (such as genetically modified food, health food), it must apply to FDA registration first. For the registration of medicine, please contact Division of Medicinal Products, the FDA, or Department of Chinese Medicine and Pharmacy, Ministry of Health and Welfare; for the registration of medical devices, please contact Division of Medical Devices and Cosmetics, the FDA; for the registration of specific food, please contact Division of Food Safety, the FDA. After receiving the official notice of the testing, the applicant shall submit samples to the FDA for testing.
To apply for the lot release testing for Biologics, pharmaceutical firms shall fill out an application form for lot release procedures of Biologics (download the application form here), and submit the application along with the requiring documents to the FDA, and pay the assessment fee upon notice (including testing fee, lot release fee, travel and delivery fee).
If you have any question about the medicines, foods and cosmetics you are using, you can ask the service center of the local health bureau or send it to the private laboratories at your own expense. Information about the testing labs and the list of detailed testing items can be found on the website of the Laboratory Accreditation Management System.
For questions about the testing method for food, please contact us through email (
TFDAmethod@fda.gov.tw
). However, one shall understand that all kinds of tests have their specific objectives and testing limits, so it is not possible to identify all risks through testing. It is recommended that you avoid questionable food, which can damage your health.
For other questions regarding drug and food testing, testing procedures, please contact us by phone ((02) 2787-8200).