1.0Registrarhttps://legacy.registrarcorp.com/zh/Mason Granduskyhttps://legacy.registrarcorp.com/zh/author/mgrandusky/美国FDA仿制药企业自认定法规rich600338<blockquote class="wp-embedded-content" data-secret="vU0ZOlOEMP"><a href="https://legacy.registrarcorp.com/zh/fda-drugs/self-identification/">美国FDA仿制药企业自认定法规</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://legacy.registrarcorp.com/zh/fda-drugs/self-identification/embed/#?secret=vU0ZOlOEMP" width="600" height="338" title="“美国FDA仿制药企业自认定法规” — Registrar" data-secret="vU0ZOlOEMP" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script>
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https://legacy.registrarcorp.com/wp-content/uploads/2019/08/press_release.jpg1650500[vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text] 美国FDA仿制药企业自认定法规 美国国会2012年通过《仿制药申报者付费法案》(GDUFA)，要求生产仿制药和仿制药原料的企业必须在每年的5月1日至6月1日之间向FDA递交“自认定”信息，FDA根据这些自认定信息来计算每年仿制药的官方申请费用。根据GDUFA，未能完成自认定的企业，其生产的仿制药将被视为参假产品。 协助企业判断其是否需要遵守FDA自认定法规要求，是否需要向FDA递交自认定信息。希望获得此项帮助，只需填写以下表格： [/vc_column_text][vc_column_text][/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]