ANVISA opens public consultation on Chinese medicine products

The National Agency for Sanitary Surveillance (ANVISA) has approved the opening of the public consultation on the regulations for products of traditional medicine of China. The goal is to determine how it will regulate products that are currently absent from the Brazilian Health Regulations.

The text of the proposal will be published in the Official Gazette in the coming days. After publication, will be 90 days to submit comments and suggestions. The consultation aims to enable the monitoring of possible effects related to the use of these products. Today there is no formula that blends traditional Chinese minerals, plants and animals with registration in Brazil.

According to CEO of ANVISA, Dirceu Barbano, products have specific characteristics that are not included in any health regulations existing in Brazil. The multifactorial composition of traditional products in China requires a differentiated analysis of health assessment, informs Barbano.

The proposal states that Chinese products will not require registration with ANVISA. The text prohibits the appointment of therapeutic claim on product labels and in promotional material. The manufacture must also follow the rules of the Chinese Pharmacopoeia, being forbidden the inclusion of raw materials of animal origin. Another proposal restricts the prescription product to qualified professionals.

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