On 9 May 2022, the National Medical Products Administration (NMPA) announced a one-month public consultation on its draft regulation. The Regulations on the Implementation of the Drug Administration Law of the People's Republic of China could impact a series of areas including the Essential Drug List (EDL), paediatric medicines and rare diseases. Xin Zhao maps out the impact these potential new regulations could have. To find out more about the market access challenges and opportunities in China, please contact Xin at enquiries@lightning.health.