By Fineline Cube China’s Center for Drug Evaluation (CDE) has released the 108th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes, introducing 28 new drugs and 18 additional specifications to the draft list. The announcement opens a public consultation period through July 9, 2026, while simultaneously revealing that 10 drug applications failed to meet review standards.
Reference Preparation Updates
| Category | Count | Details |
|---|---|---|
| New drugs added | 28 | Added to reference preparation list |
| Additional specifications | 18 | New dosage forms or strengths |
| Failed applications | 10 | Did not pass CDE review criteria |
| Public feedback deadline | July 9, 2026 | Final date for stakeholder comments |
Regulatory Context & Process
- Program: Generic Quality and Consistency Evaluation (GQCE)
- Authority: Center for Drug Evaluation (CDE), National Medical Products Administration
- Batch: 108th official reference preparation selection
- Purpose: Establish bioequivalence standards for generic drug manufacturers
- Stakeholder Engagement: 10-day public consultation period for industry feedback
Market Implications
- Generic Competition: New reference preparations enable additional manufacturers to develop competing generic versions, potentially reducing drug costs
- Quality Standards: The GQCE program ensures generic drugs demonstrate equivalent efficacy and safety to originator products
- Regulatory Efficiency: Streamlined reference preparation selection accelerates generic drug approval timelines
- Industry Impact: Failed applications indicate CDE’s rigorous evaluation standards, maintaining high quality benchmarks for market entry
The CDE’s systematic approach to reference preparation selection supports China’s broader pharmaceutical reform goals of improving drug quality, controlling healthcare costs, and fostering domestic generic drug development capabilities.
Forward-Looking Statements
This brief contains forward-looking information regarding regulatory processes. Actual implementation timelines and market impacts may vary based on final CDE decisions and industry response during the consultation period.-Fineline Info & Tech