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[摘要]
对澳大利亚政府卫生部治疗用品管理部门(TGA)的登记药品注册申报制度和证据要求进行梳理,阐述了澳大利亚补充药品的监管模式,并对《支持登记补充药品适应症所需证据的指南》《经评估登记药品的证据指南》的关键信息进行分析。TGA登记药品、经评估登记药品属于简化注册的申报程序,基于“许可成分清单”“许可适应症清单”进行申报。TGA将适应症按风险程度的高低划分为3个级别,其中低风险和中级风险适应症分别对应登记药品和经评估登记药品。对于经评估登记药品的仿制药L(A)1申请途径,可考虑借鉴该方式为中级风险适应症中药非处方药(OTC)品种的仿制提供支持。对于经评估登记药品的新药L(A)3申请途径,可考虑借鉴该方式为中级风险适应症中药新药的简化申请提供支持,此类申请路径有可能为无特定适应症的证候类中药或民族药提供支持。
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[Abstract]
The listed medicine registration system and evidence requirements of Therapeutic Goods Administration (TGA) were sorts out, and the regulatory model for complementary medicines in Australia, and analyses key information in the "guidelines on the evidence required to support indications for listed complementary medicines" and "assessed listed medicines evidence guidelines". TGA listed medicines and assessed listed medicines are simplified registration procedures, and are submitted based on the "Permissible Ingredient List" and "Permissible Indication List". TGA divides the indications into three levels according to the degree of risk, and the low-risk and intermediate-risk indications correspond to listed medicines and assessed listed medicines. For the generic drug application L(A)1 of the assessed listed medicines, it may be considered to provide support for the imitation of the OTC traditional Chinese medicine (TCM) with intermediate-risk indications. For the new drug application L(A)3 of the assessed listed medicines, consider using this method to support the simplified application of new TCM with intermediate-risk indications. It is particularly informative that the application path can provide support for TCM or ethnopharmaceuticals without specific indication.
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