Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System
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Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System
China PharmacyVol. 31, Issue 12, (2020)
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Published:2020,
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REN Lei, ZHANG Liyang, HAN Dan, et al. Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System. [J]. China Pharmacy 31(12).(2020)
DOI:
REN Lei, ZHANG Liyang, HAN Dan, et al. Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System. [J]. China Pharmacy 31(12).(2020)DOI:
Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System
OBJECTIVE:To provid e foreign experience for the improvement of sympathetic drug use system in China. METHODS:Australia’s Special Access Scheme (SAS) was introduced and analyzed in respects of applicant ,drug scope , application method ,processing flow ,main responsibilities ,drug payment and other specific content. The suggestion were put forward for the improvement of sympathetic drug use system in China. RESULTS & CONCLUSIONS :Therapeutic Goods Administration(TGA)divided SAS into 3 channels according to disease severity and drug safety ,the patients with very urgent medical conditions could use drugs directly through SAS-A channel ,and unapproved drugs with relatively high safety can also be used directly through SAS-C channel after informing TGA ;in other conditions ,drugs can be used through SAS-B channel by the form of “application-evaluation”after approved by TGA. At the same time ,Australia has made detailed regulations on the responsibilities of doctors ,government regulators and sponsor in the system ,forming a relatively perfect system. In order to improve compassionate use system ,improve the feasibility of drugs ,make drug research and development results more timely benefit clinical ,it’s suggested that we should establish multiple application channels ,construct the multi-level drug evaluation system and connect with the existing system well.
关键词
澳大利亚特别准入计划同情用药制度
Keywords
AustraliaSpecial Acce ss SchemeSympathetic drug use system