A complete set of guidance documents for clinical trials in China from 2015 to 2016

Clinical trial refers to the biological scientific research conducted by human volunteers, also known as subjects Depending on the purpose of the trial, the subjects may be patients or healthy volunteers Drug clinical trials are used to study the effectiveness, safety and quality of drugs, in order to investigate whether they can be listed for clinical trials in specific populations On July 22, 2015, CFDA released the announcement on carrying out self inspection and verification of drug clinical trial data, and the industry pattern was reversed instantly According to the statistics of yaozhi.com, as of March 1, 2016, 1622 varieties in China had been verified, 1165 of which had been voluntarily withdrawn by enterprises, 40 of which had not been approved or reviewed, and the failure rate reached 74.3% Recently, CFDA issued the Circular of the General Administration on the supervision and spot check of clinical trials of medical devices (hereinafter referred to as the circular), which requires the supervision and inspection of the authenticity and compliance of the data of clinical trials conducted before June 1, 2016 in the application for medical device registration This is the CFDA's new target after the data verification of drug clinical trials launched last year The unprecedented storm brought by multiple policies only aims to rectify the industry chaos, eliminate the industry criticism, standardize the industry order, promote the upgrading and transformation of the entire pharmaceutical industry chain, and strive to gain a place in the international market Of course, it's only the beginning to check the storm In the future, this trend will continue and may be regulated in various forms Therefore, a thorough understanding of relevant national laws and regulations, guidance documents, and a comprehensive and profound interpretation of them will be of great benefit to guiding practice The following is the clinical trial regulations and guidance documents issued by the domestic official institutions in 2015-2016, which are counted through the drug intelligence data policy and Regulations Database (http://db.yaozh.com/policies) The key words of "clinical trial" are input, all of which are clear at a glance, which can be said to be a timely help to the pharmaceutical enterprises in the clinical trial operation The specific contents are as follows (click the title to view the full text): the issuing department of the title of the regulation issues the announcement of the General Administration on the matters related to the self inspection, verification and withdrawal of drug clinical trial data and the re declaration of withdrawn varieties (2016 No 113) CFDA 2016.06.03 the General Administration issues the notice of the biostatistics guidelines for drug clinical trial (2016 No 93) CFDA 2016.06.03 Notice of the General Administration on the acceptance of electronic application for the certification of drug non clinical research quality management specifications and the qualification of drug clinical trial institutions (2016 No 110) CFDA 2016.05.31 classification of effectiveness indicators in drug clinical trials Notice on re soliciting opinions on key points of on-site inspection of clinical trials of medical devices CFDA 2016.05.18 notice on Soliciting Opinions on on on-site inspection procedures and key points of inspection of clinical trials of medical devices CFDA 2016.04.12 notice of General Office of General Administration of the people's Republic of China CFDA 2016.04.07 notice on implementing the code for quality management of clinical trials of medical devices Notice of the General Administration on the application for self inspection and registration of drug clinical trial data (No 81 in 2016) CFDA 2016.04.01 notice of the General Administration on printing and distributing the working procedures of drug clinical trial data verification (Provisional) (CFDA 2016.03.29) Code for quality management of clinical trials of medical devices (Order No 25 of the state health and Family Planning Commission of the people's Republic of China of the State Food and Drug Administration) CFDA 2016.03.23 code for quality management of clinical trials of medical devices CFDA 2016.03.07 statistical consideration of missing data in clinical trials CDE electronic publication 2016.03.01 consideration of clinical trial design and evaluation of 13 valent pneumococcal conjugate vaccine 2016.01.29 technical guidelines for electronic data collection (EDC) of clinical trials CDE 2016.01.29 guidelines for planning and reporting of data management and statistical analysis of drug clinical trials CDE 2016.01.29 Circular on Soliciting Opinions on guidelines for general consideration of drug clinical trials CDE 2015.12.21 Notice of food and Drug Administration on Further Strengthening the self inspection and verification of drug clinical trial data CFDA 2015.12.17 consideration of technical evaluation of seasonal influenza inactivated vaccine clinical trial CDE electronic publication 2015.12.01 basic consideration of application evaluation of new drug clinical trial CDE electronic publication 2015.11 Notice of the State Food and Drug Administration on the self inspection and verification of drug clinical trial data (2015 No 117) CFDA 2015.07.22 notice of the State Food and Drug Administration on the public solicitation of opinions on the administrative measures for the accreditation of clinical trial institutions of medical devices (Draft) CFDA 2015.07.20 Several considerations on clinical trials of new Chinese medicine for liver fibrosis: expert consensus on the preparation of new antimicrobial clinical trials fold points in CDE electronic journal July 1, 2015 letter on Seeking Opinions on matters related to clinical trials filing of medical devices (CFDA) April 28, 2015 on Seeking Opinions on the revised draft of quality management Specification for clinical trials of drugs (CFDA) 2015.02.06 notice on Soliciting Opinions on regulations on the administration of drug clinical trial institutions CFDA 2015.02.06 guiding principles for Biostatistics of drug clinical trials (Draft for comments) CDE 2015.8.19 build a platform for registration and information publicity of drug clinical trials to promote the protection of subjects' rights and interests To explore a new method of international multi center clinical trial design sgddp Huangqin CDE journal 2015 key technical points in clinical trials of new Chinese medicine for stroke treatment Liu Binglin CDE journal 2015