China's clinical trial registrations reached a historic high in 2025, reflecting robust growth in pharmaceutical innovation and deeper integration into the global development landscape, according to a report released by the National Medical Products Administration (NMPA) on Monday.
The Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2025) says the total number of clinical trial registrations crossed the 5,000 threshold for the first time, reaching 5,215 in 2025.
"In 2025, the NMPA received a total of 5,215 registered clinical trials, a year-on-year increase of 6.4 percent, hitting a record high and doubling the number from 2020," said Yang Zhimin, deputy director of the Center for Drug Evaluation (CDE) under the NMPA.
The registrations fall into two major categories: new drug clinical trials and bioequivalence trials. New drug clinical trials amounted to 2,997, accounting for 57.5 percent of the total and rising 18 percent year on year, while bioequivalence trials reached 2,218, taking up the remaining 42.5 percent.
To bring innovative medicines to patients sooner and gain a competitive edge in global research and development, China has streamlined the full workflow of clinical trials to shorten launch cycles. The report shows that 1,088 new drug clinical trials obtained their first subject's informed consent in 2025, with the average launch duration cut by four months compared with the previous year.
"More than 40 percent of applicants completed trial registration and submission within one month, and over 70 percent of the applications secured the first informed consent within six months," said Wang Haixue, director of the clinical trial management division at the CDE.
The improved efficiency has translated into more novel therapies available to patients across a wider range of conditions.
"In 2025, a total of 248 new drugs were approved for marketing after completing clinical trials, covering 18 therapeutic areas including oncology, endocrinology and mental disorders," said Yang.
Beyond domestic progress, China is expanding its global footprint in clinical research. The report records 410 international multi-center clinical trials in 2025, making up 13.7 percent of the year's total. The NMPA noted that China's clinical trial technical guidelines have aligned with international standards, advancing the global mutual recognition of clinical data and results.
"The number of international multi-center clinical trials for new drugs doubled in 2025 from the 2020 level, involving more than 70 countries and regions, with the largest number of trial sites located in the United States, Japan and Germany," Wang said.
"This means domestic innovative companies are gradually shifting from participating to leading global multi-center clinical trials, becoming a major force in international cooperation. China's clinical trials have not only attracted global innovative resources but also deeply integrated into the global drug research and development system, significantly enhancing the country's influence and voice," Yang said.
China's clinical trial registrations hit record high in 2025
