China CDE Issues Guidance on Frontline Indication Trials of Anticancer Drugs Using Later-line Data

China's Center for Drug Evaluation has issued the Technical Guidance for Clinical Trials of Frontline Indications of Anticancer Drugs Based on Later-line Study Data (Announcement No. 48 of 2026), published on October 23, 2026 and effective the same day. The guidance aims to protect patient safety, ensure scientifically rigorous trial design, and provide a reference technical standard for conducting frontline-indication clinical trials based on later-line study data. The announcement was approved by the National Medical Products Administration.