OBJECTIVE： To expound and prove development risk control pathway and diversified remedy mechanism in drug liability， and to provide reference the improvement of related system. METHODS： Through expounding and proving the legitimacy of defense in drug development risk， the balanced relationship between drug producers’ R&D and innovation and sufferers’ rights protection were analyzed. RESULTS & CONCLUSIONS： The drug development risk should be controlled by drug liability legislation through specifying the standards of drug development risk， clearing the obligation of post-sale duties， emphasizing the drug design step in the manufacturing process， refining the national industry standards. It relies mainly on the special relief fund system， while drug liability compulsory insurance system subsidiary to minimize the loss of patients suffered from drug development risk. The drug development risk fund system should be constructed in fields of fund sources， application condition， compensation range， remedy program， etc. to improve development risk remedies.