Procedures for Selecting and Determining Reference Listed Drugs (RLDs)
Request Procedures for Selecting and Determining Reference Listed Drugs (RLDs)
  • Local Title:化学仿制药参比制剂遴选与确定程序
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Regulation
  • Status:In force
  • Release Date:2019-03-28
  • Implementation Date:2019-03-28
Document
Language Source Title Access
ZH Official 化学仿制药参比制剂遴选与确定程序 Download
Summary

As per the Procedures for Selecting and Determining RLDs, to add a drug to the Catalog of Reference Listed Drugs (RLDs), a generic drug applicant, drug research/manufacturing company, or industry association should submit an RLD listing application to the Center for Drug Evaluation (CDE).

The submission procedures are as follows:

RLD Listing Application Procedures in China