The Chinese Management Consensus on Compassionate Use of Investigational New Drugs in Medical Institutions(2026)

In accordance with the Pharmaceutical Administration Law of the People's Republic of China revised in 2019 and the Implementing Regulations of the Pharmaceutical Administration Law of the People's Republic of China effective in 2026, Peking Union Medical College Hospital led the development of The Chinese Management Consensus on Compassionate Use of Investigational New Drugs in Medical Institutions(2026). This consensus was formulated by convening a multidisciplinary panel of experts, including health policy specialists, clinicians, pharmacists, methodologists, ethicists, and industry representatives, following the consensus development process recommended by the World Health Organization handbook and the Chinese Medical Association. As the first management consensus in China specifically addressing compassionate use of investigational drugs, this document provides 19 recommendations across eight key domains: eligibility criteria for compassionate use, scope of application, target patient populations, responsibilities of relevant stakeholders, key points for application and review, patient informed consent, risk prevention and control, and cost-bearing arrangements. This consensus aims to standardize the clinical practice of compassionate use of investigational drugs within medical institutions, enhance awareness of this issue among healthcare institutions in China, address the clinical needs of critically ill patients requiring urgent treatment, and provide recommendations and references for the establishment of standardized compassionate use management procedures.