By Fineline Cube 
China’s National Medical Products Administration (NMPA) today released its 98th Reference Listed Drugs (RLD) list for chemical generic drugs, adding 60 drug specifications to the catalogue. The update includes 42 specifications for original brand‑name drugs that have not yet been imported into China, signalling a broader push to streamline generic drug approvals and increase access to essential medicines.
Key Highlights
- Total Specifications Added – 60 items, bringing the overall RLD count to 98.
- Unimported Brand‑Name Drugs – 42 specifications represent original brand‑name drugs that remain unavailable in the Chinese market.
- Regulatory Impact – The new list will facilitate the review of generic applications, potentially accelerating market entry for both domestic and foreign manufacturers.
What the RLD List Means for China’s Pharmaceutical Landscape
- Accelerated Approval Pathways – Generic manufacturers can reference the new RLD specifications to expedite their approval processes under the “generic drug registration” framework.
- Enhanced Drug Availability – Inclusion of unimported brand‑name drugs opens the door for Chinese firms to develop quality‑matched generics, boosting competition and lowering costs for patients.
- Strategic Alignment – The update aligns with the Chinese government’s “Made in China 2025” strategy to strengthen domestic innovation while maintaining rigorous safety and efficacy standards.
Next Steps for Stakeholders
- Manufacturers – Review the full RLD list to identify opportunities for portfolio expansion and regulatory alignment.
- Healthcare Providers – Stay informed on new generic options that may become available following regulatory clearance.
- Investors – Monitor the pipeline of newly listed drugs for potential investment in emerging generic manufacturers.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech