Notice of the General Administration on Matters Related to Sharp Aisi Eye Drops

Release time:


Food and Drug Administration of Zhejiang Province:


In view of the fact that some doctors in the medical field have questioned the efficacy of bendarine lysine eye drops (trade name: sapace) produced by Zhejiang sapace Pharmaceutical Co., Ltd., please urge enterprises to start clinical effectiveness tests as soon as possible in accordance with the relevant provisions of the the People's Republic of China Drug Administration Law and the consistency evaluation of quality and efficacy of generic drugs, And report the evaluation results to the drug evaluation center of china food and drug administration within three years. In order to prevent misleading consumers, the drug approval advertisement should be strictly in accordance with the text specified in the instructions for indications, and should not have text content beyond the instructions for indications.



General Administration of Food and Drug Administration

December 6, 2017