Briggs David R
Office of Complementary Medicines, Therapeutic Goods Administration, P.O. Box 100, 2609 Woden, ACT, Australia.
Toxicology. 2002 Dec 27;181-182:565-70. doi: 10.1016/s0300-483x(02)00483-3.
Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity.
包括澳大利亚的草药在内的补充药物受治疗产品法规监管。基于风险，澳大利亚制定了两级治疗产品监管方法。列入清单的药物被认为风险低于注册药物。大多数（但不是全部）补充药物是列入清单的药物。对包括补充药物在内的治疗产品相关风险的管理，是通过制造商许可程序、产品上市前评估以及上市后监管活动来进行的。草药的风险可能低也可能高，这取决于成分的毒性、建议剂量、适应症的适当性以及自我诊断和管理的声称以及不良反应的可能性。注册药物在投放市场前会对其安全性、质量和有效性进行单独评估。列入清单的药物由治疗产品管理局进行单独评估以确保符合法规，它们在上市前不进行评估。它们只能由那些经过上市前安全性和质量评估且被认为风险较低的成分制成。列入清单的补充药物只能针对非严重病症的症状缓解、健康维持、健康增强和风险降低进行表述和声称。澳大利亚风险管理的一个重要特征是，低风险补充药物的早期市场准入得到适当的上市后监管活动的支持。
