NMPA and NHFPC jointly published “procedures for review and approval of imperative new overseas clinical medicine”

On 30th of October, National Medical Products Administration (NMPA) and National Health Commission (NHFPC) jointly published “procedures for review and approval of imperative new overseas clinical medicine” The principles refer to imperative new overseas medicines imported from America, European Union or Japan, which do not enter the Chinese market currently.  The imperative new overseas medicines in accordance with one of following requirements are adapted to this review and approval principles and procedures:

  • Medicine for rare disease;
  • Medicine applied to top serious or fatal disease without any valid drugs by now;
  • Medicine applied to top serious or fatal disease with great clinical merits

http://www.nmpa.gov.cn/WS04/CL2138/331475.html