国外膳食营养补充剂市场分析及监管制度研究——澳大利亚

Research on the market and regulatory system of dietary nutritional supplements in Australia

随着消费者对健康产品的接受和广泛使用,尤其是海外市场的需求增长,澳大利亚膳食营养补充剂产业呈现快速发展态势,行业持续繁荣。澳大利亚将膳食营养补充剂作为补充药物类别管理。澳大利亚治疗产品管理局(TGA)对补充药品的监管分为上市前评估、上市后监督和执行标准监督。为澳大利亚供应补充药品的境外生产企业须符合并接受与该国生产企业要求标准等效的药品生产质量管理规范(GMP),并获得TGA批准。

With the acceptance and widespread use of health products by consumers, especially the growing demand in overseas markets, the Australian dietary supplement industry has shown a rapid development trend, and the industry continues to prosper.Australia manages dietary supplements as a supplementary drug category.The Australian Therapeutic Goods Administration(TGA) regulates supplementary drugs through pre-market evaluation, post market supervision, and standard enforcement supervision.Overseas production enterprises supplying supplementary drugs to Australia must comply with and accept Good Manufacturing Practice(GMP) standards equivalent to those required by domestic production enterprises, and obtain TGA approval.