China NMPA Approves 289 New Drugs in 2025 as Study Flags Flaws in TCM Clinical Trials

In 2025, China's National Medical Products Administration approved 289 new drug applications, a total that includes traditional Chinese medicines. Concurrently, a cross-sectional study of 400 randomized clinical trials of Chinese herbal medicine published between 1992 and 2024 has identified persistent methodological weaknesses, raising concerns about the evidence base for these therapies.

The study, published in JAMA Network Open, found that many trials lacked a clear hypothesis, adequate protocols, or registration. Allocation concealment was often insufficient, and a large proportion did not specify a primary outcome or estimate required sample sizes. Handling of missing data was suboptimal, and sensitivity or subgroup analyses were rarely performed satisfactorily. The analysis did note improvements in trial design and reporting over time, and studies appearing in English-language or higher-impact journals tended to be of better quality. The authors call for standardized methodological guidelines and intersectoral collaboration to strengthen the planning and conduct of such trials.

Meanwhile, the regulatory pipeline continues to accept traditional medicines. The NMPA's 2025 approvals cover chemical drugs, therapeutic biological products, and traditional Chinese medicines in classes 1, 2 and 3.

In a separate development, researchers are turning to nanotechnology to overcome long-standing limitations of traditional Chinese medicine compounds. A review in the International Journal of Nanomedicine describes how nanoformulations can address low bioavailability and lack of targeting that hamper many herbal active ingredients. Focusing on renal fibrosis — the final common pathway of chronic kidney disease, which affects 800 million people worldwide — the authors summarize five classes of nanocarriers and the anti-fibrotic mechanisms of four major types of compounds: flavonoids, anthraquinones, phenolic compounds, and glycosides. Preclinical evidence suggests these targeted delivery systems may enhance efficacy, but significant hurdles remain, including batch-to-batch consistency, long-term safety evaluation, and establishment of regulatory pathways.