The NMPA has released Batch 98 of the Reference Preparations List for Generic Drugs, providing an updated catalogue of chemical generic drug reference preparations. The list includes product names, specifications, global availability, approved manufacturers, and import status, supporting high-quality generic drug evaluation and development.

Key Highlights:

  • Catalogue includes updates for Levothyroxine, Dalbavancin, Methylprednisolone, Lorosilide, Roflumilast, Valbenazine, and others
  • Many reference preparations continue to be imported from the USA for use in the Chinese market
  • Highlights original research status and domestic approval trends across listed products
  • Reinforces compliance with the Chinese Pharmacopoeia and related guidelines for new drug approvals

This update strengthens Regulatory clarity on reference preparations and supports consistent quality for generic drug development.

Consult Now

Source
https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20251118150906125.html
Select Mandate HA
NMPA
Select Mandate Function
Regulatory Affairs