CFDA published the draft Administrative Measures for Drugs Compassionately used in Extended Clinical Trials (Draft for Comment) (“Draft”) on 15 December 2017. It is open for public opinion until 15 January 2018. The Draft provides that under certain conditions, unapproved drugs may be released for patients with urgent clinical need. The usage shall be free of charge and must be approved by the authority in advance. The data collected during the usage may be used to assess the safety evaluation component of the drug registration process.