Challenges in anticancer drug R&D in China

The availability of innovative drugs in China has long been compromised by the so-called drug lag, in which a lengthy drug review processes, scarcity of domestically developed innovative drugs, overly strict policies in clinical trial application, and import drug registration has impeded drug innovation. 1 Shao L Xu L Li Q Chakravarthy R Yang Z Kaitin KI Regulatory watch: innovative drug availability in China. Nat Rev Drug Discov. 2016; 15: 739-740 Google Scholar , 2 Mullard A Chinese biopharma starts feeding the global pipeline. Nat Rev Drug Discov. 2017; 16: 443-446 Google Scholar To tackle this dilemma, the Chinese Government has issued a series of regulatory reforms on drug administration since 2017. 3 China Food and Drug AdministrationPolicies on reforming clinical trial administrations and encouraging drug and medical device innovations. http://samrcfdagovcn/WS01/CL0087/172568htmlDate: 2017 Date accessed: April 8, 2018 Google Scholar , 4 China Food and Drug AdministrationNotice of the general administration of the people's republic of China on releasing the work program for the reform of the classification of chemical drugs registration. http://samrcfdagovcn/WS01/CL0087/146603htmlDate: 2016 Date accessed: April 8, 2018 Google Scholar , 5 China Food and Drug AdministrationOpinions of the state council regarding deepening reforms on the examination and approval system, encouraging drug and medical device innovations. http://wwwgovcn/xinwen/2017-10/08/content_5230105htmDate: 2017 Date accessed: April 8, 2018 Google Scholar , 6 China Food and Drug AdministrationDecisions about adjustments of regulations on import drug registration and management. http://samrcfdagovcn/WS01/CL1031/178363htmlDate: 2017 Date accessed: April 3, 2018 Google Scholar , 7 China Food and Drug AdministrationPolicies on accelerating reviews and approvals of new drugs and medical devices to encourage drug and medical device innovations. http://samrcfdagovcn/WS01/CL0087/172567htmlDate: 2017 Date accessed: April 4, 2018 Google Scholar The changing landscape of drug research and development (R&D) in China is captured by an annual report of China's phase 1 oncology studies (appendix).