By Fineline Cube 
The National Medical Products Administration (NMPA) today announced the release of its 95th Reference‑Listed Drugs (RLD) catalog. The update incorporates 35 brand‑new drug specifications and revises 31 previously listed specifications, reflecting changes in marketing authorization holders and product details.
Key Highlights
| Item | Detail |
|---|---|
| New Additions | 35 drug specifications, all listed for the first time |
| Updates | 31 existing specifications modified – including marketing authorization holders and product specifications |
| Catalog Impact | Enhances the regulatory framework for generic drug approval and market entry in China |
What This Means for the Pharmaceutical Industry
- Accelerated Access – New RLD entries streamline the pathway for generic manufacturers to enter the Chinese market.
- Regulatory Clarity – Updated specifications provide clearer guidance on product quality, labeling, and authorized marketing holders.
- Market Dynamics – The broadened catalog may intensify competition in key therapeutic areas, potentially driving price reductions and increased availability for patients.
NMPA’s Ongoing Commitment
The NMPA continues to refine the RLD process, aiming to balance rigorous safety and efficacy standards with the need to expand therapeutic options across China. The latest catalog release is part of a broader initiative to modernize drug registration and approval procedures.-Fineline Info & Tech