China’s revised Implementing Provisions of the Drug Administration Law took effect on May 15, 2026. This marks the first major update to the regulations in more than two decades.
Most notably, the use of overseas clinical research data in drug registration applications will be explicitly allowed under the amended provisions. Even though China began accepting overseas clinical trial data as early as 2017 and provided corresponding guidelines in 2018, the new provisions provide a solid legal framework for the use of overseas clinical trial data. The overseas research data can be used in drug registration applications in China as long as the data comply with the relevant standards and requirements in China, such as the Chinese GCP requirements.
Second, the amendments to the provisions elevate four of the currently existing fast-track mechanisms to the level of national regulations. They include the breakthrough therapy program, conditional approval pathway, priority review and approval pathway, and special approval pathway. These fast-track programs were introduced as part of the NMPA’s drug registration measures before, but lacked legal status – now they do have it.
Each pathway is intended to accelerate access to drugs that address significant public health concerns. Breakthrough therapy and priority review pathways support products for serious or life-threatening conditions. Conditional approval allows certain drugs to reach the market based on early clinical evidence when unmet medical needs are high. The special approval pathway targets products needed during public health emergencies.