Notice on the Procedures and Requirements for Submission of Materials for the Approval of Generic Names of Drugs
Release time:
2025-04-03
To implement the "Regulations on Drug Registration Management" (Order No. 27 of the State Administration for Market Regulation), and standardize the approval process for generic drug names, the National Pharmacopoeia Commission has drafted the "Approval Procedures for Generic Drug Names," "Requirements for Submission of Materials for Application of Generic Names for Innovative Traditional Chinese Medicines," "Requirements for Submission of Materials for Application of Generic Names for Chemical Drugs," and "Requirements for Submission of Materials for Application of Generic Names for Biological Products" (see Attachments 1-4). These documents have been reviewed and approved by the National Medical Products Administration and are now released. Applications for marketing licenses submitted after the implementation date of the "Regulations on Drug Registration Management" that require generic name approval must comply with the relevant requirements of this announcement.
This is an official announcement.
Attachment 1: Procedures for Generic Drug Name Designation.pdf
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