China's annual clinical trial registrations top 5,000 for first time

The annual number of clinical trials registered in China surpassed 5,000 for the first time in 2025, doubling the figure recorded in 2020, according to a report released on Monday by the National Medical Products Administration.

The report, published by the NMPA's Center for Drug Evaluation, showed that the number of international multicenter clinical trials reached 410 in 2025, nearly double the 2020 level.

Of the more than 5,000 clinical trials registered last year, 57.5 percent were conducted for new drugs, totaling 2,997 trials and marking an 18 percent year-on-year increase. The remainder consisted of bioequivalence studies designed to evaluate the performance of generic drugs.

Clinical trials involving cell and gene therapies continued to rise significantly, with oncology remaining the dominant therapeutic area. Meanwhile, the number of trials for rare disease drugs, medical imaging and radiopharmaceuticals, as well as studies of new drugs in pediatric populations, remained relatively stable.

Chinese drug regulators have also prioritized accelerating the entire clinical trial process to speed patient access to high-quality medicines.

In 2025, the average time from regulatory approval to trial initiation for new drugs was shortened by four months compared with the previous year. In addition, a record-high 74.2 percent of trials obtained informed consent from the first participant within six months of approval.

According to the administration, 248 new drugs were approved for market entry in 2025, spanning 18 therapeutic areas, including oncology, endocrinology and mental disorders.