對澳大利亞政府衛(wèi)生部治療用品管理部門（TGA）的登記藥品注冊申報制度和證據要求進行梳理，闡述了澳大利亞補充藥品的監(jiān)管模式，并對《支持登記補充藥品適應癥所需證據的指南》《經評估登記藥品的證據指南》的關鍵信息進行分析。TGA登記藥品、經評估登記藥品屬于簡化注冊的申報程序，基于“許可成分清單”“許可適應癥清單”進行申報。TGA將適應癥按風險程度的高低劃分為3個級別，其中低風險和中級風險適應癥分別對應登記藥品和經評估登記藥品。對于經評估登記藥品的仿制藥L（A）1申請途徑，可考慮借鑒該方式為中級風險適應癥中藥非處方藥（OTC）品種的仿制提供支持。對于經評估登記藥品的新藥L（A）3申請途徑，可考慮借鑒該方式為中級風險適應癥中藥新藥的簡化申請?zhí)峁┲С?，此類申請路徑有可能為無特定適應癥的證候類中藥或民族藥提供支持。

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.