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Simplifying Regulatory Submissions with e-CTD and Digital Dossier Management
August 02, 2024Employing e-CTD and digital dossier management systems will not only support faster submission processes but also improve the accuracy and reliability of the data presented to regulators. -
NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings
July 23, 2019To implement the requirements in the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Urgently Needed in Clinical Settings (No. 79 of 2018) and expedite the review & approval of ...
Pharma Sources Insight January 2025
