Notice of the State Food and Drug Administration on the application of the guiding principles of 15 international human drug registration technical coordination committees (No. 88, 2019), such as E1: population exposure: assessment of the clinical safety of long-term treatment drugs for non life threatening diseases

In order to promote the technical standards of drug registration in line with the international standards, through research, the State Drug Administration decided to apply 15 guiding principles of the International Conference for the technical coordination of human drug registration (ICH), such as E1: population exposure: assessment of the clinical safety of drugs for long-term treatment of non life threatening diseases (see Annex for details) The relevant matters are hereby announced as follows 1、 From the date of promulgation of this announcement, E2F: safety update report during research and development, E2F example, E5 (R1): racial factors of accepting foreign clinical trial data, E5 Q & A (R1) and E17: General principles of multi regional clinical trial planning and design are applicable 2、 The applications for listing of new drugs accepted six months after the issuance of this announcement are applicable to E3: structure and content of Clinical Research Report and E3 Q & A (R1) 3、 The E2E: pharmacovigilance plan is applicable to the new drug listing applications accepted 3 months after the date of this announcement and approved 6 months later 4、 The relevant requirements of drug clinical research launched six months after the date of publication of this announcement are applicable to E4: information of dose effect relationship required for drug registration, E7: Research of special population: geriatric medicine, E7 Q & A, E8: General considerations of clinical trials, E9: statistical principles of clinical trials, E10: selection of control group in clinical trials and relevant requirements Question "," E11 (R1): clinical drug research of medical products for pediatric population "," E15: definition of genome biomarkers, pharmacogenomics, pharmacogenetics, genome data and sample coding classification "," E16: biomarkers related to drug or biological product research and development: background, structure and format of qualification submission materials " 5、 The clinical trial application approved six months after the date of promulgation of this announcement and the new drug listing application accepted three years later are applicable to E1: population exposure: assessment of the clinical safety of long-term treatment drugs for non life threatening diseases 6、 Six months after the date of this announcement, the clinical study of new antihypertensive drugs is applicable to e12a: Principles for clinical evaluation of new antihypertensive drugs, in which the sample size of subjects required for safety evaluation is required to meet the requirements of E1 implementation time point Relevant technical guidelines can be found on the website of drug evaluation center of SDA The drug evaluation center of SDA shall be responsible for the relevant technical guidance during the implementation of this announcement It is hereby announced Attachment: 15 applicable ICH e series three-level guidelines penicillin this article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.