Accelerating the establishment of management systems for compassionate use in China.

• Compassionate use (CU) refers to the therapeutic use of unapproved drugs outside of clinical trials to expand treatment options for critically ill patients. • Given the potential risks, CU requires more specific protections for patients than standard clinical care, calling for sound legal regulatory related to CU. • In China, however, almost all current laws fail to mention the specific regulations on CU, leaving a lot of room for improvement in fulfilling the responsibilities of CU. • Over the last decade, China has been striving to improve relevant laws and regulations for CU with initial results. • To meet the urgent needs of critically ill patients, we call for establishment sound management system for CU as soon as possible in China. [ABSTRACT FROM AUTHOR]