RESUMO
In this report, we emphasize the importance of public monographs with reference materials, coupled with careful process and change control and attention to GMPs, as a means of advancing access to good quality, safe, and effective medicines, with emphasis on available and incoming biologic medicines. With adequate control of articles covered by a monograph, these public standards can form the basis for a global public quality platform that covers reference products, non-interchangeable reference products, biosimilars, and interchangeable biosimilars. Working collaboratively with all stakeholders, new approaches allow these public standards to emerge nationally and globally in a timely way. Yet, there are increasing limitations in the availability of public standards for biologic medicines, which may reverse many decades of progress. Solutions are considered in this report.
Assuntos
Fatores Biológicos/normas , Fatores Biológicos/uso terapêutico , Fatores Biológicos/efeitos adversos , Humanos , Legislação de Medicamentos , Farmacopeias como Assunto , Padrões de Referência , Estados UnidosRESUMO
The role of the United States Pharmacopeia (USP) in the regulation of dietary supplements, USP's dietary supplement verification program and the challenges and scientific issues in the standardization of botanicals and related products are discussed.
Assuntos
Suplementos Nutricionais/normas , Contaminação de Medicamentos , Humanos , Farmacopeias como Assunto , Saúde Pública , Padrões de Referência , Estados UnidosRESUMO
The development of USP botanical dietary supplement monographs by the Subcommittee on Natural Products (1995-2000) and the Dietary Supplements-Botanicals Committee of Experts (2000-2005) of the USP is described in this review. Featured details include the USP as an organization, focusing upon its history, mission, and publication of the United States Pharmacopeia-National Formulary (USP-NF); the formulation and composition of botanical dietary supplement monographs and related general chapters, as well as appropriate admission criteria; and a summary of the accomplishments of the Committees (1995-2005).
