China NHC Issues Fourth Batch of Encouraged Generic Drugs Catalogue

On 4 January 2026, China’s National Health Commission, together with the Ministry of Industry and Information Technology, the National Intellectual Property Administration, the National Healthcare Security Administration, and the National Medical Products Administration, jointly issued the “Fourth Batch of the Catalogue of Encouraged Generic Drugs” (the “Fourth Batch Catalogue”).

The catalogue lists 21 drug varieties and 47 specifications across oncology, neurology, assisted reproduction, rare diseases, and radiopharmaceutical diagnostics. More than a simple product list, it indicates where China is directing regulatory coordination, technical guidance, and development support within its generic drug system.

For overseas manufacturers, the catalogue serves as a policy-guided reference for identifying products that align more closely with national health priorities and demonstrate clearer development feasibility.

Regulatory Context

Since its first release in 2019, China’s encouraged generic drug catalogue has evolved into a policy tool that coordinates regulatory review, industrial development, reimbursement considerations, and intellectual property planning Across four batches, the catalogues now cover 110 drug varieties, forming a long-term framework guiding generic drug development.

Rather than mandating procurement or pricing outcomes, the catalogue:

Primarily signals products that are prioritized for cross-agency coordination and technical support
Provides direction for R&D planning by both domestic and overseas manufacturers, particular in areas of unmet clinical need or limited domestic development capacity

Clinical Priorities Reflected in the Catalogue

The Fourth Batch Catalogue focuses on therapeutic areas where treatment options remain limited or where domestic R&D capability is comparatively weak.

Emphasis on New Targets and Weak Domestic Coverage

Priority is given to products involving new targets or novel mechanisms of action, especially in areas with limited domestic development.

These include:

Difelikefalin for moderate to severe chronic kidney disease–associated pruritus in hemodialysis patients
Four radiopharmaceuticals not yet marketed in China, covering therapeutic, diagnostic, and localization uses

Greater Attention to Dosing Precision and Patient Adherence

The catalogue reflects increasing regulatory attention to dosing flexibility and real-world treatment adherence. Lumateperone for schizophrenia is listed in three strengths (10.5 mg, 21 mg, and 42 mg), enabling clinicians to adjust dosing based on patient response and tolerability.

Alignment With International Clinical Practice

Products recognized as first-line therapies in overseas guidelines received priority consideration. Suvorexant for insomnia, which addresses both sleep onset and maintenance with a reduced risk of next-day sedation, helps expand treatment options for clinicians and addresses gaps in existing therapies available in China.

Support for National Health Policy Objectives

In support of childbirth-related policy initiatives, the catalogue prioritizes improved assisted reproduction formulations.

Progesterone vaginal sustained-release gels and suppositories are included due to their ability to reduce injection-related adverse reactions commonly associated with long-term oil-based progesterone use during IVF and embryo transfer.

Balancing Access and Clinical Familiarity

For rare disease, accessibility is balanced with existing clinical practice. Deflazacort for Duchenne muscular dystrophy is included to support continuity of care while improving supply stability and regulatory clarity.

How the Fourth Batch of Generic Drugs Catalogue Was Designed

The Fourth Batch Catalogue adopts a more disciplined approach to generic drug selection, focusing on alignment between clinical need, development feasibility, and long-term supply sustainability.

Product selection was led by the National Health Commission through a coordinated, multi-department process involving clinical, regulatory, pharmaceutical, and intellectual property experts. Dosage forms and specifications were evaluated individually through specialty consultations, with final inclusion determined through independent expert voting.

A key refinement in this batch was the integration of feasibility considerations at the selection stage. Authorities assessed global and domestic R&D progress, active pharmaceutical ingredient availability, and anticipated clinical uptake before publication.

This approach aims to reduce the number of projects that stall after listing due to technical, supply-chain, or clinical adoption challenges, reflecting a broader policy shift toward execution quality rather than symbolic inclusion.

Strategic Implications for Overseas Manufacturers

For overseas manufacturers, the Fourth Batch Catalogue provides a clearer reference point for product prioritizing within China’s generic drug market.

Products already recognized as first-line therapies in international clinical guidelines, such as suvorexant for insomnia and deflazacort for Duchenne muscular dystrophy, allow manufacturers to leverage:

Established clinical evidence
Validated manufacturing systems to support more efficient development and regulatory submission in China

At the same time, products involving new targets or novel mechanisms (including difelikefalin and selected radiopharmaceuticals) offer opportunities in segments with relatively weaker domestic competition. These areas are more likely to receive sustained policy attention, making early positioning strategically meaningful despite higher technical and development complexity.

From a regulatory perspective, the catalogue also helps concentrate review and coordination resources on products with a higher likelihood of successful development and long-term supply.

Final Thoughts

China’s Fourth Batch of the Encouraged Generic Drugs Catalogue reflects a continued shift toward feasibility, clinical relevance, and execution quality in generic drug policy. The emphasis has moved away from expanding the breadth of listed products toward improving the likelihood that listed products can be successfully developed, approved, and sustainably supplied.

For overseas manufacturers, the catalogue provides early visibility into regulatory priorities and a practical basis for portfolio screening and resource allocation within China’s evolving generic drug framework.

With more than 20 years of on-the-ground regulatory experience in China, Cisema helps overseas manufacturers navigate evolving policy frameworks and make informed, compliant decisions across the full product lifecycle.

For international biopharma companies evaluating product prioritization, regulatory positioning, or China market entry pathways, get in touch with Cisema today for practical, experience-based support.