Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial)
Request Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial)
  • Local Title:化学仿制药参比制剂调整程序
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Regulation
  • Status:In force
  • Release Date:2023-03-23
  • Implementation Date:2023-03-23
Document
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ZH Official 化学仿制药参比制剂调整程序 Download
Summary

As per the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial), drugs in the RLD Catalog with any of the below three conditions are subject to adjustment:

  1. The drug has been withdrawn from the market due to safety or efficacy reasons.

  2. The drug is not encouraged to be copied because it, even though after technological improvement, still cannot meet the criteria in the current Chinese Pharmacopoeia or the technological requirements for drug review.

  3. Other conditions: after being evaluated, the drug is deemed not fulfilling the RLD criteria.

Related: China May Delist Ineligible RLDs of Chemical Generic Drugs