Objective: To study and analyze the regulatory policies for the listing of traditional Chinese medicine products in Brazil, and provide reference for the listing of traditional Chinese medicine products in Brazil. Methods: By using textual study and comparative research method, this article analyzed the ‘Regulations on the Manufacturing and Commercialization of Traditional Chinese Medicine Products’(RDC 21/2014) in Brazil, and compared it with the ‘Decision on the Extension of Regulations on the Manufacturing and Commercialization of Traditional Chinese Medicine Products’ (RDC 280/2019), and the ‘Notice on the Registration of Herbal Medicines and the Registration of Traditional Medicine Products" (RDC 26/2014). Results and Conculsion: Brazil is in the stage of inclusiveness in the use and supervision of traditional Chinese medicine, and has adopted restrictive and loose policies. It is suggested that drug regulatory authorities and traditional Chinese medicine research institutions strengthen exchanges and cooperation in the fi elds of traditional Chinese medicine supervision and research.
Yuan Bo, Sun Fuyun, Lu Zhong, Mo Jieli, Yao Lixin, Wu Guiping
. Analysis of the Listing and Regulatory Policy for Traditional Chinese Medicine Products in Brazil and the Enlightenment for China[J]. Chinese Pharmaceutical Affairs, 2023
, 37(5)
: 583
-587
.
DOI: 10.16153/j.1002-7777.2023.05.012
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