OBJECTIVE: To establish the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” based on the Delphi method

so as to provide methodological basis for further studies on drug risk assessment in pregnancy. METHODS: By referring to the literature related to drug risk assessment in pregnancy

the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” was established

and the expert consultation questionnaire was designed. Fifty-one experts from Beijing

Shanghai and other provinces and cities were selected to apply the Delphi method for two rounds of expert consultation to revise the content of the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China”. RESULTS: The recovery rates of the two rounds of questionnaire were 100%. The expert authority coefficient（Cr） was 0.80±0.10

the coefficient of variation（CV） of expert opinion was 0.15±0.04 in the first round and 0.13±0.03 in the second round

and the coordination coefficient of expert opinion（Kendall-W） was 0.170 in the first round and 0.493 in the second round.In both rounds

Chi-square test showed statistically significant differences（P<0.001）. Finally

the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China” was determined. CONCLUSIONS: The Delphi method is used to establish the “Expert Consensus on Risk Assessment of Drugs in Pregnancy in China”

which provides methodological basis for the risk assessment of drugs during pregnancy in China.