According to the state council on reform of the opinions of the drug review of medical equipment examination and approval system “(guo fa [2015] 44), the state food and drug supervision and management of the administration of drug registration for examination and approval of the review a number of policy announcement no. 230 (2015), and other requirements, since December 1, 2015, chemical medicine bioequivalence (BE) test from examination and approval system to record management. Will now matters related to notice the following: (1) registration applicant shall pay the relevant taxes in accordance with the drug registration laws related to the second, a registered applicants for chemical medicine BE experiment was carried out, to the state food and drug supervision and management of the administration of chemical medicine BE test record information platform (hereinafter referred to as registration platform, website: www.chinadrugtrials.org.cn), fill out the registration information according to the requirement, and submit for the record, access to the record number. Third, before fill in the registration information, registered applicants need to submit testing scheme for drug clinical trial institution to BE test ethical committee review, and the contract signed with drug clinical trial institution BE test. Four, registration applicant shall supervise the clinical test units to BE test and the relevant responsible persons according to the test plan organization BE test. BE test, after the completion of the registration to the applicant food five, the provinces (autonomous regions and municipalities directly under the central government) the food and drug administration is responsible for the registration of the applicant within their respective administrative areas, it is necessary to develop drug clinical trial institution BE test for routine supervision and administration, and BE of registration applicants complete test data to verify the authenticity, integrity. After verification through, by inspectors to draft the verification opinion, issued by the provincial food and drug administration is responsible for the comrades submitted to the state food and drug administration bureau. Six, total bureau of national food and drug supervision and administration of the registration of the applicant for the record data is analyzed and the technical evaluation, to record information is obvious defects and security on the high risk, registered timely inform the applicant, the end BE test. Administration of state food and drug supervision and administration of drug approval center in the process of technical evaluation, to record information and BE test after the completion of the application for registration of the relevant information is proposed for inspection and sampling inspection; Found problems authenticity, will not approve the application, to the society and public authenticity problems; When it is necessary to initiate an investigation, shall be investigated for registration the applicant and the responsibility of the person in charge of clinical trials and the local provincial food and drug regulators regulatory responsibilities of relevant personnel. Seven, on December 1, 2015 has been accepted, the application for registration of the relevant chemical medicine registration applicant may continue to review by the original program to BE test after examination and approval, can also take the initiative to withdraw the original registration according to the requirements for the record to BE test after the announcement. Eight, on December 1, 2015, I no longer accept in accordance with the provisions of this notice situation of chemical medicine BE trial registration. Notice is hereby given that the. Attachment: the food and drug supervision administration on December 1, 2015. 

(SOURCE: Medical Blackboard News)