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1 行政机构及有关事务美国药品的管理机构是FDA和医药品生物制剂局(Center for Drugs and Biologics),负责药品的申批、生产、销售等药事管理工作。新药申请(New Drug Application)或销售许可有保健部(HHS)指导。所有新药申请(NDA),包括补充申请(Supplemental NDA),必须符合1985年修订的FD356H所规定的格式。在申请书里除申请者外,对有公开资格的辩护人、代理人或当局职员均需署名。生物制剂企业的申请,由生物制剂审查部确认具有一定生物技术知识,并能承担该企业责任
1 Administrative agencies and related matters The U.S. drug regulatory agencies are the FDA and Center for Drugs and Biologics, where they are responsible for the administration of drug applications, production and sales. New Drug Application or marketing approval is provided by the HHS. All new drug applications (NDA), including supplemental applications (Supplemental NDA), must be in the form prescribed by FD356H as amended in 1985. In addition to the applicant in the application, the defenders, agents or officials of the public are required to sign the name. The application of a biological agent enterprise shall be confirmed by the Biological Reagent Examination Department as having certain biotechnology knowledge and can assume the responsibility of the enterprise