The National Medical Products Administration (NMPA) of China has posted a notice to set the processing deadline for new drug clinical trial applications within 30 days, similar to the United States. This plan aims to halve the current 60-day period and accelerate the clinical process.
According to the announcement posted by the NMPA on July 16, the NMPA proposed to reduce the waiting period for clinical trial reviews of new drugs from the current 60 days to 30 days. The 30-day timeline will apply to two projects under the supervision of the Center for Drug Evaluation (CDE) that have clear clinical value supported by the Chinese government, including cancer and rare disease treatments, global clinical trials conducted simultaneously in China, and multinational clinical trials led by Chinese researchers.
Similar to the U.S. Food and Drug Administration (FDA), the NMPA plans to adopt a method for questioning clinical trial reviews, allowing the trial to proceed automatically if the sponsor does not raise an objection to the regulatory agency within a specified period.
The NMPA plans to gather opinions on the new rules until July 16, and the implementation of this announcement will align with the FDA's processing deadline of 30 days.
China has actively pursued regulatory relaxation for clinical trials over the past decade. In 2015, it first allowed multinational clinical trials for overseas drugs, and in 2017, it officially joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to devise global guidelines. In 2018, it introduced a 60-day clinical trial review period policy and transitioned to an objection-based system.
A representative from the Korea Biotechnology Industry Organization noted, "Until transfer in 2018, the standard waiting period for Clinical Trial Application (IND) submissions by China's NMPA was over 6 months to more than a year," adding, "This appears to be a response to the increasing bio-capabilities of China and the rise in clinical trials conducted there."
According to a report by the market research firm IQVIA, the share of China in new clinical trials sponsored by pharmaceutical corporations surged from 8% in 2013 to 29% in 2023. In South Korea, the global share of pharmaceutical company-led clinical trials rose from 6th place in 2021 to 5th in 2022, and then to 4th in 2023, but is expected to drop two places to 6th in 2024.