Data: 17/08/2023
https://fi-admin.bvsalud.org/document/view/v9xmw
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