CDE issues the Inactive filing number in around 3-6 months counting from step 2 data gap analysis.
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Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients. and Packaging Materials (2020 Draft for Comments)
[contact-form-7 id=”1436″ title=”DownLoad – Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients. and Packaging Materials (2020 Draft for Comments)”]
Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review & Approval and Supervision (2019 No.56)
[contact-form-7 id=”1432″ title=”DownLoad – Announcement on Further Improvement of Drug (2019 No.56)”]
Announcement for Adjusting Evaluation and Approval for APls, Excipients and Packaging Materials (2017 No.146)
[contact-form-7 id=”1435″ title=”DownLoad – Announcement for Adjusting Evaluation and Approval for APls, Excipients and Packaging Materials (2017 No.146)”]
Provisions for Drug Registration (2020 No.27)
[contact-form-7 id=”1434″ title=”DownLoad – Provisions for Drug Registration (2020 No.27)”]
Drug Administration Law (2019 No.31)
[contact-form-7 id=”984″ title=”DownLoad – Drug Administration Law (2019 No.31)”]