“Guiding Principles of Real-World Evidence supporting Drug Development and Review (Trial)” is formally promulgated by NMPA
On January 7th, 2020, NMPA promulgated “Guiding Principles of Real World Evidence supporting Drug Development and Review (Trial)”. It introduces the background and purpose of Real-World Research/Study (RWR/RWS), relevant definitions, the role of Real-World Evidence (RWE) in drug regulatory decision, the basic design of RWS, the evaluation of RWE and communication with review agencies. This…