Upton Roy, Agudelo Ignacio, Cabrera Yadira, Caceres Armando, Calderón Angela, Calzada Fernando, Camacho Rosa, da Costa Fernando, Dobrecky Cecilia, Enciso Roberto, Escobar Marcela, Fakhary Mina, Fletcher Edward, Gao Quanyin, Lock Olga, Mata Rachel, Parada Mirtha, Perera Wilmer, Pombo Luis Miguel, Reich Eike, Sanchez Eric, Simirgiotis Mario Juan, Sood Christian, Amiguet Virginie Treyvaud, Villar Martha, Ghelman Ricardo, Schveitzer Mariana Cabral, Portella Caio Fábio Schlechta, Wolffenbüttel Adriana, Ruppelt Bettina, Frickmann Fabiana Souza, Gavillan-Suarez Janette, Allen Kristin, Alvarado Luis Diego, Sarma Nandakumara, Marles Robin, Monagas Maria, Navarro-Hoyos Mirtha
American Herbal Pharmacopoeia, Scotts Valley, CA, United States.
Facultad de Farmacia y Bioquímica, Departamento de Farmacología, Cátedra de Farmacobotánica, Universidad de Buenos Aires, Buenos Aires, Argentina.
Front Pharmacol. 2024 Aug 30;15:1426210. doi: 10.3389/fphar.2024.1426210. eCollection 2024.
The United States Pharmacopeial Convention (USP) is a nonprofit, scientific, standard-setting organization, and world leader in establishing quality, purity, and testing standards for medicines, foods, and dietary supplements. USP quality standards are used in more than 140 countries and are legally recognized by more than 40 countries. Currently, there is renewed interest in herbal medicines globally, and health policies are being implemented worldwide for the use of complementary and traditional medicine. In response, USP has developed a robust body of monographs that can be used to guide industry and regulators in ensuring the quality and safety of botanical ingredients used in dietary supplements and herbal medicines. Throughout the Pan American regions, there is a strong tradition of using botanicals as herbal medicines and, as in other regions, a growing desire for botanical dietary supplements. This underscores the need for public quality standards to ensure quality, reduce the flow of substandard and adulterated products, and ensure public health and safety. In April 2022, USP launched the Pan America Botanical Dietary Supplements and Herbal Medicines Expert Panel, with experts representing 12 different countries. The Expert Panel's work focuses on developing quality control standards for the most important botanical ingredients used in the respective countries, ingredients that are also of global importance. This article provides an overview of the state of botanical dietary supplements and herbal medicines in different Pan American regions with a focus on the regulatory status of herbal products, the development of national quality and research initiatives, and policies related to agriculture conservation and sustainability, among other topics.
美国药典委员会(USP)是一个非营利性的科学标准制定组织,在制定药品、食品和膳食补充剂的质量、纯度及检测标准方面处于世界领先地位。USP的质量标准在140多个国家得到应用,并在40多个国家获得法律认可。目前,全球对草药的兴趣再度兴起,世界各地都在实施有关使用补充和传统医学的卫生政策。作为回应,USP制定了大量的专论,可用于指导行业和监管机构确保膳食补充剂和草药中使用的植物成分的质量和安全。在整个泛美地区,有着将植物用作草药的悠久传统,并且与其他地区一样,对植物性膳食补充剂的需求也在不断增长。这凸显了制定公共质量标准以确保质量、减少不合格和掺假产品流通以及确保公众健康和安全的必要性。2022年4月,USP发起成立了泛美植物性膳食补充剂和草药专家小组,小组成员来自12个不同国家。专家小组的工作重点是为各国使用的最重要的植物成分制定质量控制标准,这些成分在全球也具有重要意义。本文概述了泛美不同地区植物性膳食补充剂和草药的状况,重点关注草药产品的监管状况、国家质量和研究举措的发展以及与农业保护和可持续性相关的政策等主题。