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Regulatory Framework of Herbal Medicine in Cuba

Data: 17/08/2023

https://fi-admin.bvsalud.org/document/view/v9xmw

Coleção: GTMSummit - The First WHO Traditional Medicine Global Summit

This infographic outlines the regulatory framework for herbal medicine in Cuba, as part of its broader Natural and Traditional Medicine (NTM) strategy. The Cuban Regulatory Agency (CECMED), recognized by WHO’s International Regulatory Cooperation for Herbal Medicines (IRCH), oversees herbal medicine regulation to ensure quality, safety, and efficacy. It presents four core national regulations: authorization requirements (28-2013), good manufacturing practices (16-2003 and 54-2012), and sanitary licensing (85-2016). The infographic details the administrative, chemical, pharmaceutical, biological, non-clinical, and clinical data required for registering herbal products. It emphasizes the integration of good practices in agriculture, manufacturing, laboratory, and clinical settings to achieve therapeutic consistency.

Autor(es): Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED); Ministerio de Salud Pública de Cuba; Organización Mundial de la Salud (OMS); Organización Panamericana de la Salud (OPS) Idioma: Inglês Duração: .pdf
Assunto(s): Medicina Herbária; Controle de Medicamentos e Entorpecentes; OHSAS 18000; Farmacognosia; Avaliação de Medicamentos; Produtos Biológicos; Medicina Tradicional; Naturologia; Fitoterapia
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