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    Home > Active Ingredient News > Drugs Articles > Announcement of the State Food and Drug Administration on the filing management of bioequivalence test of chemical drugs (2015 No. 257)

    Announcement of the State Food and Drug Administration on the filing management of bioequivalence test of chemical drugs (2015 No. 257)

    • Last Update: 2015-12-02
    • Source: Internet
    • Author: User
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    Source: CFDA 2015-12-2 in accordance with the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), the announcement of the State Food and Drug Administration on several policies for the review and approval of drug registration (2015 No 230) and other requirements, since December 1, 2015 Since, the bioequivalence test of chemical drugs (hereinafter referred to as be) has been changed from approval system to record management The relevant matters are hereby announced as follows: 1 The registration applicant shall carry out be test research in accordance with the relevant laws, regulations and technical requirements of drug registration to ensure the scientificity, ethical rationality of the research, the authenticity and accuracy of the research materials and the traceability of the research process 2 If the registration applicant needs to carry out the chemical be test, he / she can log in to the "chemical be test filing information platform" (hereinafter referred to as the filing platform, website: www.chinadrugtrials Org CN) of the State Food and drug administration, fill in the filing information as required, submit the filing information and obtain the filing number III before filling in the filing information, the registration applicant shall submit the trial scheme to the ethics committee of the drug clinical trial institution undertaking the be trial for ethical review, and sign the be trial contract with the drug clinical trial institution IV The registration applicant shall supervise the clinical trial institution undertaking the be test and the relevant responsible person to organize the be test according to the test scheme After the be test is completed, the registration applicant shall apply to the food and Drug Administration for drug registration and submit relevant materials 5 The food and Drug Administration of each province (autonomous region, municipality directly under the central government) is responsible for the daily supervision and management of the be test conducted by the registration applicant and the drug clinical trial institution within its administrative region, and the verification of the authenticity and integrity of the be test data completed by the registration applicant After the verification is passed, the inspectors shall draft the verification opinions, which shall be signed and issued by the person in charge of the provincial food and Drug Administration and submitted to the State Food and drug administration VI The State Food and drug administration shall analyze and evaluate the filing data of the registration applicant If there are obvious defects in the filing data and high risks in safety, the registration applicant shall be informed in time and the be test shall be terminated During the technical review, the drug review center of the State Food and drug administration may After the completion of the test, the relevant materials of registration application shall be submitted for cause verification and sampling inspection; if any problem is found in the authenticity, the application will not be approved and the problems in the authenticity will be disclosed to the public; if necessary, the case shall be filed for investigation, and the responsibility of the registration applicant and the person responsible for the clinical test shall be investigated, as well as the supervision responsibility of the relevant personnel of the local provincial food and drug regulatory department VII For the relevant chemical drug registration applications accepted before December 1, 2015, the registration applicant can continue to carry out be test after passing the review and approval of the original procedures, or can voluntarily withdraw the original registration application and carry out be test after filing according to the requirements of this announcement VIII From December 1, 2015, our bureau will no longer accept the registration application for the be test of chemical drugs that meet the requirements of this announcement It is hereby announced Appendix: filing scope and procedures for bioequivalence test of chemical drugs annex.docx to Announcement No 257 of food and Drug Administration on December 1, 2015
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