By Fineline Cube 
The China Center for Drug Evaluation (CDE) has published a draft list of the 98th batch of reference standards for chemical generic drugs and is now calling for public comments. The move is part of CDE’s ongoing effort to streamline the approval process for generic medicines while ensuring quality and safety.
Draft List Highlights
- 21 new drug specifications – Standards for drugs that have not been previously released.
- 38 supplemental specifications – Updated information for drugs already on the market.
- 9 failed‑review specifications – Entries that did not meet the required criteria and are awaiting revision.
Why It Matters
Reference standards serve as the benchmark for quality control in the manufacturing of generic drugs. By opening the 98th batch for public scrutiny, CDE aims to gather input from industry stakeholders, academia, and the broader public, potentially accelerating the availability of affordable, high‑quality generics across China.
Public Consultation Window
- Submission period: July 18 – August 18, 2025.
- How to comment: Stakeholders can submit written comments through the CDE’s online portal or by email.
- Next steps: CDE will review all feedback, make necessary revisions, and finalize the standards by early 2026.
Industry Implications
The inclusion of 21 new specifications signals a continued push toward expanding the generic drug portfolio, while the 9 failed reviews underscore the CDE’s commitment to rigorous quality control. Companies that rely on these standards for production will need to monitor revisions closely to ensure compliance and avoid potential delays in market entry.-Fineline Info & Tech