What are herbal medicines (FM) and what are traditional herbal products (PTF), what is the difference between them?
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The herbal medicine is considered exclusive of plant raw materials, it must be characterized by the constancy of it´s quality, it´s safety and efficacy must be based on clinical evidence.
Traditional herbal products are also considered exclusive of plant raw materials, the difference is in their use, which does not need the supervision of a doctor, that is, without diagnosis, prescription and monitoring.
These products cannot refer to diseases, disorders or actions considered serious, and cannot contain raw materials in a concentration of toxic risk.
It is not considered herbal medicine or traditional herbal product that includes in its composition isolated or highly purified active substances, whether synthetic, semi-synthetic or natural.
In both alternatives the requirements regarding quality control will be the same, they differ in the proof of safety and efficacy/effectiveness.
According to RDC 26 of May 13, 2014, in order to prove the safety and efficacy of the herbal medicine, it will be necessary to present to ANVISA, clinical and non-clinical trials of the product.
The safety and effectiveness of the Traditional Phytotherapeutic Product is proven through the traditional use.
Herbal medicines are subject to registration and traditional herbal products are subject to registration or notification
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