192 drugs will be on the market soon, and Hengrui, Qilu and Tianshi will have a good harvest

Source: China food and Drug Administration June 7, 2018 announced to China food and drug administration that it was going to check 192 drugs, including Tianshili, Huabei pharmaceutical, Shiyao, Hengrui, Zhengda Tianqing, hausen, etc Among them, 153 generic drugs stepped into the final threshold before going on the market On June 6, the State Food and Drug Administration issued the announcement of the State Food and Drug Administration on the application for self inspection and registration of drug clinical trial data (No 30, 2018) (hereinafter referred to as the announcement) According to the announcement, the State Drug Administration has decided to verify the clinical trial data of 192 newly received drug registration applications (see Annex) that have been applied for production or import of clinical trials After combing, sabran found that 192 drugs include 19 new drugs, 153 generic drugs, 7 imported drugs, 8 imported re registration and 5 supplementary applications According to the comments of pharmaceutical economic news, since July 22, 2015, the National Bureau issued the notice on clinical trial data verification (2015 No 117), which started serious supervision on the data authenticity and integrity of the registered application varieties In the past three years, the routine self-examination and the normalization verification have entered a new supervision stage In addition, with the development of self-examination and verification of clinical trial data of 192 varieties, these drugs will cross the final threshold of listing declaration, that is to say, in the near future, a number of drug companies will usher in the harvest period The relevant matters are as follows: 1 Before the organization of verification by the SDA, if the applicant for drug registration finds that there is a problem in the authenticity of the clinical trial data, he / she shall withdraw his / her application for registration on his / her own initiative, and the SDA shall publish his / her list and shall not be held responsible 2 The food and drug examination and inspection center of the State Food and Drug Administration will publicize the on-site inspection plan on its website, and notify the drug registration applicant and the provincial food and drug administration where it is located After 10 working days of publicity, the center will notify the on-site inspection date, and will no longer accept the withdrawal application of the drug registration applicant III The SDA will seriously deal with the applicant, the person in charge and manager of the drug clinical trial, and the person in charge of the contract research organization who found data fraud in the on-site verification of the drug clinical trial data Attachment: application list for self inspection and registration of 192 drug clinical trial data