RESUMEN
OBJECTIVE:To provide reference and basis for strengthening the drug quality supervision of medical institutions.METHODS:The problems about the drug quality supervision of the medical institutions were analyzed from the angle of legislation.Countermeasures for strengthening drug quality supervision of medical institutions in China as well as legislative suggestions on improving drug quality supervision of medical institutions in China were put forward.RESULTS & CONCLUSIONS:At present,the existing problems about drug quality supervision in medical institutions include that pharmacy setting lack mandatory standards;routine drug quality supervision is mainly the formal regulation;the punishment of drug related illegal behavior in medical institutions is too light,etc.To strengthen drug quality supervision of medical institutions in China,it is suggested that the government should establish the mandatory standards for medical institution pharmacy setting,add administrative inspections,and formulate Good Using Practice applicable to the whole country.When perfecting the law of drug quality supervision in medical institutions in China,relevant provisions may be added in The Drug Administration Law of the PRC,Regulations for the Implementation of Drug Administration Law,and the subordinate laws and regulations of Management Regulation of Medical Institutions so as to strengthen drug quality supervision of medical institutions.
RESUMEN
OBJECTIVE:To provide reference for the improvement of supervision system of online drug sale in China. METH-ODS:Usingonline pharmacyonline drugstoreinternet drugssupervisionas keywords,CNKI,Wanfang database from Jan. 2015 to Jan. 2016 and related websites were retrieved,experience about legislation,legal provisions and regulatory bodies in the United States,Britain,Germany and other countries were summarized. The problems existing in the current supervision system in China were analyzed,and related suggestions were proposed. RESULTS & CONCLUSIONS:The legal system of the online drug sale in the United States,Britain,Germany and other countries is more complete,legislation content is relatively perfect,pay-ing attention to the combination of administrative supervision and industry supervision. The supervision system of online drug sale in China exists problems as follows as legislation level relatively lower,conflict between laws and regulations;the legislation con-tent being not perfect,contents missing or provisions blur in many aspects;law enforcement existing in the government depart-ments,industry regulation being weak and others. It is suggested that the country should develop high-order law when improving the supervision system of online drug sale,modifying the existing law or promulgating the relevant specialized laws by legal form rather than regulations and rules;develop clear,actionable law and learn from foreign related systems (such as electronic evi-dence,blacklist)to improve legal contents;and further clear the powers and responsibilities of the regulatory authorities,actively develop industry associations(such as pharmaceutical association,etc.)to conduct supervision for online drug sale.