摘要
<span style="font-family:Verdana;">In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for </span><span style="font-family:Verdana;">U.S. pharmaceutical manufacturers</span><span style="font-family:""><span style="font-family:Verdana;"> as described in the </span><i><span style="font-family:Verdana;">Compliance Program Guidance for Pharmaceutical Manufacturers</span></i><span style="font-family:Verdana;"> issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug regis</span><span style="font-family:Verdana;">tration stages. Finally, some suggestions and implications are proposed to </span><span style="font-family:Verdana;">strengthen the construction of compliance management for Chinese drug</span><span style="font-family:Verdana;"> registration applicants based on the former practical experience.
<span style="font-family:Verdana;">In order to achieve the goal of drug safety, effectiveness and quality control, corporate compliance management construction is significant. Therefore, this paper systematically analyzes the seven elements of compliance management for </span><span style="font-family:Verdana;">U.S. pharmaceutical manufacturers</span><span style="font-family:""><span style="font-family:Verdana;"> as described in the </span><i><span style="font-family:Verdana;">Compliance Program Guidance for Pharmaceutical Manufacturers</span></i><span style="font-family:Verdana;"> issued by the HHS-Office of Inspector General, as well as further analyzes the implementation of the guidance by representative multinational companies in different drug regis</span><span style="font-family:Verdana;">tration stages. Finally, some suggestions and implications are proposed to </span><span style="font-family:Verdana;">strengthen the construction of compliance management for Chinese drug</span><span style="font-family:Verdana;"> registration applicants based on the former practical experience.
