Application for registration of chemical generic injection is under strict investigation! Five situations will meet the inspection center's on-site inspection

Source: on May 14, 2018, pharmaceutical economic news, the official website of the State Drug Administration announced that in order to strictly review and approve the drug injection, ensure the safety and effectiveness of drugs, it was decided to strengthen the on-site inspection on the registration application of chemical generic drugs Since the date of announcement, for the registration application of chemical generic injection accepted by the provincial drug regulatory authorities and under the review and approval of the State Drug Administration, the State Drug Administration will increase the effort of cause based inspection The drug review center of the State Food and Drug Administration (hereinafter referred to as the drug review center) will, on the basis of strict review, according to the needs of review The food and drug audit and inspection center of the State Food and Drug Administration (hereinafter referred to as the "inspection center") shall carry out the on-site inspection when the requirements for on-site inspection are put forward Five situations need on-site inspection 1 Changes in the prescription, process, internal packaging materials and production equipment of the injection belong to category III changes or major changes specified in the technical guidelines for change research of listed chemicals (I) and the technical guidelines for change research of production process of listed chemicals 2 The production location (production line) of domestic preparations is changed 3 The chemical injection type is applied for the first time, and no other varieties have been produced in the corresponding production line 4 It is found during the review that the authenticity needs to be verified 5 Those who need to be verified after receiving the clues of complaints and reports about authenticity and reliability The key inspection center will carry out on-site inspection on the registration application of chemical generic injection according to the needs of the review and notify the registration applicant The inspection focuses on the overall implementation of the drug production quality management standard level and the sterility assurance ability of the declared varieties by the registration applicant, as well as the dynamic production batch situation when the varieties are declared, including the consistency and authenticity of the production batch and the declared data If necessary, the inspection center may require the registration applicant to arrange dynamic production and sampling inspection during the inspection In case of the first and second cases, the drug Audit Center will not notify the provincial drug regulatory authorities to repeat the production site inspection after the review According to the announcement, if the registration applicant finds that the registration application content of the relevant chemical generic injection is untrue or incomplete, it can apply for withdrawal before the inspection center notifies the on-site inspection The withdrawal application will not be accepted after notification of on-site inspection If any authenticity problem or even fraud is found in the on-site inspection, it will be seriously investigated and punished according to law.