Abstract：OBJECTIVE To analyze the development status, supervision system and existing problems of drug patient assistance programs in China, and to provide suggestions for improving relevant management systems. METHODS Through the literature research and the combing of the patient assistance platform, summary the basic implementation mode of drug patient assistance and the status quo of patient assistance supervision system. RESULTS =According to the 81 patient assistance programs, assistance was provided for patients via the charity organizations after pharmaceutical companies donate drugs to them. The assistance modes include co-assistance, financial aid, full-free drugs. Based on the Law of the People′s Republic of China on Donation of Public Welfare, the Law of the People′s Republic of China on Philanthropy, the Regulations about the Administration of the Importing Donated Drugs, the current regulatory system put forward request towards several aspects, including the subject of assistance programs, reasonable use of drugs, drug quality insurance and related legal liability. However, there are still some problems that the behavior of different subjects during the assistance process is not clearly defined, the assistance of domestic drug is not included in the supervision system, the lack of regulation about donee. CONCLUSION It is necessary to improve the laws and regulations, clarify the legal characteristics of patient assistance programs, emphasize the regulatory requirements about domestic drug assistance, and establish the whole process management system for the storage, supply and use of patient assistance drugs.
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