The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened a public consultation for the 104th Batch of the “Reference Listed Drugs (RLD) Catalog for Chemical Generics.” The draft catalog includes 63 total specifications under review, comprising 15 newly added, 32 supplemented, and 16 failed evaluations.
Regulatory Update
Item
Detail
Regulatory Body
Center for Drug Evaluation (CDE), NMPA
Document
104th Batch Reference Listed Drugs (RLD) Catalog
Action
Public consultation opened
Consultation Type
Draft catalog for chemical generics reference standards
Total Specifications
63
— Newly Added
15
— Supplemented
32
— Failed Evaluation
16
RLD Catalog Significance
Function
Impact
Bioequivalence Standard
Defines reference products for generic drug development and approval
Quality Benchmark
Ensures chemical generics meet innovator product standards
Market Access
Inclusion enables generic developers to proceed with bioequivalence studies
Regulatory Clarity
Failed evaluations provide guidance on non‑viable reference pathways
Strategic Implications
Generic Development Guidance: The 104th batch update provides critical reference standards for domestic and multinational generic manufacturers seeking NMPA approval for chemical generics in China.
Portfolio Planning:15 newly added specifications represent new generic opportunities; 32 supplemented entries clarify existing standards; 16 failures signal regulatory expectations for bioequivalence feasibility.
International Harmonization: RLD catalog alignment with FDA Reference Listed Drugs and EMA reference products supports global generic development strategies and mutual recognition pathways.
Market Competition: Expanded RLD catalog enables greater generic competition, potentially accelerating price reductions and improving access to essential medicines in China’s healthcare system.
RLD updates inform lifecycle management and patent strategy for innovator products approaching expiry
Regulatory Consultants
60‑day consultation period provides opportunity for stakeholder input on contested specifications
Healthcare System
Broader generic availability supports national drug procurement and reimbursement cost containment
Forward‑Looking Statements This brief contains forward‑looking statements regarding final catalog publication, generic approval timelines, and market access implications. Actual results may differ due to risks including consultation feedback revisions, regulatory policy changes, and bioequivalence study complexity.-Fineline Info & Tech
By Fineline Cube