Reply on the legality of production and sales of APIs, pharmaceutical excipients and drug packaging materials

On April 16, the State Food and Drug Administration issued a reply from the General Department of the State Food and Drug Administration on the legality of the production and sales of rosuvastatin calcium API of Shangyu Jingxin Pharmaceutical Co., Ltd Zhejiang Drug Administration: your request for instructions on the legality of production and sales of rosuvastatin calcium API of Shangyu Jingxin Pharmaceutical Co., Ltd (zyjz [2019] No 1) has been received After research, we hereby reply as follows: 1 The approved APIs, pharmaceutical excipients and drug packaging materials shall continue to be valid within the validity period, and can continue to be used in the original drugs upon expiration of the validity period (except the APIs, pharmaceutical excipients and drug packaging materials banned or eliminated by the state) In case of clinical trials or production applications for other preparations, registration shall be completed or relevant materials shall be submitted together with the application 2、 Your bureau shall earnestly fulfill the responsibility of local drug supervision, strictly implement the "four strictest" requirements, continuously improve the awareness of risk prevention and control, strengthen daily supervision, carry out extended inspection when necessary, urge the production enterprises to organize production in strict accordance with the approved prescription and process, strengthen the review of original and auxiliary suppliers, maintain the continuous compliance of the production process, and ensure the drug safety of the people General Department of State Food and Drug Administration April 4, 2019