By Fineline Cube 
The China Center for Drug Evaluation (CDE) has released a draft list of the 100th batch of reference standards for chemical generic medicines and is now seeking comments from industry stakeholders, academia, and the public. The notice, posted on 4 Nov 2025, outlines 73 individual specifications and invites feedback through the CDE’s online portal until 30 Nov 2025.
Composition of the Draft List
| Category | Number of Specifications | Description |
|---|---|---|
| Newly Introduced Standards | 38 | Drug specifications that have never been published before. |
| Supplementary Updates | 18 | Additional data or clarifications for drugs that already have published standards. |
| Failed Review | 17 | Specifications that did not meet CDE’s technical criteria and were rejected. |
Why the 100th Batch Matters
- Regulatory Transparency – Publishing a comprehensive reference‑standard list supports quality‑by‑design and aligns Chinese generic drugs with international benchmarks (e.g., USP, EP).
- Market Impact – Manufacturers must align their production processes with the approved standards to maintain registration eligibility and avoid supply‑chain disruptions.
- Innovation Incentive – The 38 new specifications create entry points for R&D investment in previously underserved therapeutic areas.
How to Submit Feedback
- Access the Draft List – Visit the CDE website’s “Reference Standards” section (URL:
www.cde.org.cn/reference2025). - Register an Account – Provide organization details and contact information.
- Upload Comments – Submit a PDF or Word document (max 5 MB) outlining technical objections, supporting data, or suggestions.
- Deadline – All comments must be received by 23:59 Beijing Time on 30 Nov 2025.
Potential Outcomes
- Standard Adoption – Accepted specifications become mandatory references for generic drug registration and post‑market surveillance.
- Re‑evaluation – Rejected or partially accepted items may be re‑submitted in the next batch (101st) after additional data are provided.
- Policy Adjustments – Feedback may prompt the CDE to refine its evaluation criteria, influencing future generic‑drug approval timelines.
Forward‑Looking Statements
This brief contains forward‑looking statements concerning the impact of the 100th batch of reference standards on China’s generic‑drug market. Actual results may differ due to regulatory changes, stakeholder responses, and market dynamics.-Fineline Info & Tech