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Do you want to use the USP Pending Monograph process?或你曾想过USP待定文理过程是什么 和它如何详细工作阅读文章解释PMP全景或浏览视频汇总两者均基于USP信息Moreover, you can download the different guiding process graphics from USP here!
What is the USP Pending Monograph Process for Excipients?
The traditional USP revision process addresses products that are already approved, but the Pending Monograph process allows for development of monographs or monograph revisions for articles awaiting approval by FDA.并允许在药典论坛发布这些建议,以便根据USP典型修改请求过程发布通知和评论。
何时可用?
PMP允许新版或修订版专论更快成为官方版比开发仅在FDA最终批准后启动时可能更快。
USP待定文摘进程允许以多种不同方式开发这些建议,视所需修改类型和预期批准前可用时间而定。在任何情况下,这些建议都保持非正式状态,直到FD核准由捐赠者持有的市场应用程序。
注意:
USP will share this information with the FDA prior to moving the proposal forward.
What are the Application Requirements for Excipient's Pending Monographs?
- Requests for revision under the Pending Monograph approach will be accepted from sponsors:
Who have filed with FDA an Abbreviated New Drug Application (ANDA) or Abbreviated New Animal Drug Application (ANADA)!或 向FDA提交生物相似或互换生物许可应用smaster文件提交FDA引用ANDA、ANADA或BLA或 - 主体时间范围应用或公民请求修改FDAOTC药物专论Submissions from other sponsors may also be accepted on the case-by-case basis.
Additional Information:
- Unless USP determines otherwise, if the proposed monograph includes the use of a new USP Reference Standard then USP will not publish the proposed monograph in PF until it has received the necessary reference standard bulk.
- If the sponsor has filed an ANDA or ANADA or BLA, it must agree to inform USP promptly of any changes or additions that should be made to a pending monograph as a result of the regulatory review and approval process (including, but not limited to, providing USP with the dissolution test included in the approved product specification).This will help ensure consistency between the monograph proposal and the private specification approved by FDA.
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