The State Council of the PRC released a document on 11 September 2018, clarifying the role of the recently restructured National Medical Products Administration (“NMPA”) which is formerly named China National Drug Administration. NMPA will be responsible for:

  • the supervision of quality and safety regarding medicines, medical devices and cosmetics;
  • drafting regulations and national standards for medicines, medical devices and cosmetics;
  • the registration of medicines, medical devices and cosmetics;
  • the post-marketing risk control of medicines, medical devices and cosmetics; and
  • the registration of licenced pharmacists, etc.

Some departments of the State Council of PRC have been reorganised since March 2018 (see our previous Law-Now article here). The responsibilities of China Food and Drug Administration (“CFDA”) are split into two new departments: the State Administration for Market Supervision will take the responsibilities related to food administration; other responsibilities will be transferred to NMPA.

To read the full text of the government publication (in Chinese only), please click here.