Guiding Principles for Real World Evidence in Support of Drug R & D and Approval (Trial)

Tofurther guide and standardize the real-world evidence work in Support of Drug R& D and Approval, and to ensure the quality and efficiency of drug R &D, NMPA issued < Guiding Principles for Real World Evidence in Support ofDrug R & D and Approval (Trial)>.

Definition: Real-world data refers to avariety of data collected on a daily basis related to the patient's health and/ or diagnosis, health care. Not all real-world data can become real-worldevidence after analysis. Only real-world data that meets applicability canproduce real-world evidence.

Real-world evidence have five uses:

1. Provide evidence of effectiveness andsafety for new drug registration

2. Provide evidence for changing labelingof marketed drugs

3. Provide evidence for post-marketingrequirements or re-evaluations

4. Summary of clinical research anddevelopment of famous traditional Chinese medicine experience prescriptions

5. Regulatory use: a) Guide clinical studydesign

b) Pinpointing target groups