Sorting out the policy documents related to the conformity evaluation of generic drugs

Source: yaozhi.com.2018-06-15.1 Overview: the generic drug consistency evaluation is an important part of the "three medical linkage" reform Its impact is not limited to generic drugs, but it puts forward new, higher and stricter standards for drug quality and efficacy, and comprehensively regulates and cleans up the industry "Consistency" is the abbreviation of "consistency of quality and efficacy of generic drugs" In other words, "consistency" includes that generic drugs are consistent with reference drugs in quality and efficacy The quality of drugs is usually related to a series of standards and specifications, such as Pharmacopoeia of the people's Republic of China, GMP, GSP and other drug quality standards, etc., to ensure that drugs meet the requirements of these standards and specifications through technical and management means Te is usually evaluated by bioequivalence (be) 2、 Starting as early as January 2012, the notice of the State Council on printing and distributing the 12th Five Year Plan for national drug safety (GF [2012] No 5) pointed out the problems existing in the domestic drug industry at that time, and put forward the goal From then on to March 2016, the former State Food and Drug Administration issued several documents, such as the Circular of the State Food and Drug Administration on the technical guidelines for the dissolution test of general oral solid preparations and the technical guidelines for the stability study of chemical drugs (APIs and preparations) (No 3, 2015), the practice of the bioequivalence test of chemical drugs by the State Food and drug administration Announcement of bank record management (2015 No 257), etc During this period, the most important policy is the announcement of the State Food and Drug Administration on the self inspection and verification of drug clinical trial data (2015 No 117), which directly triggered the "722 Massacre" nicknamed by the industry, and also predicted the strict requirements of the subsequent consistency evaluation on the authenticity of various clinical trial data The opinions of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs issued on March 5, 2016 marks the beginning of this round of conformity evaluation On the same month 18, CFDA issued the Circular of CFDA on three technical guidelines for selection and determination of reference preparations for general oral solid preparations (2016 No 61), which can be regarded as the fundamental document for technical guidelines in consistency evaluation 3、 The general requirements for the selection of reference preparation, dissolution in vitro and bioequivalence in human body are given in Circular No 61, 2016 of the State Administration of food and drug Subsequently, various documents were issued to provide detailed regulations on reference filing, absence or inability to determine the reference preparation, in vitro dissolution study, in vivo bioequivalence study, in vivo bioequivalence exemption, on-site verification, CO production varieties, etc From the perspective of dosage form classification, the main body of consistency evaluation is oral solid preparations From the perspective of product treatment category, varieties with long application time, accurate clinical efficacy and large dosage become the first batch of products to be evaluated Specifically, 289 varieties of chemical drugs are listed in the annex of the announcement of the General Administration on the implementation of relevant matters (No 106 in 2016) Limited to space, only three categories of reference preparation, bioequivalence and oral solid preparation are displayed here For more details, see the annex 1 Reference preparation 2 Bioequivalence 3 Attachment of oral solid preparation: summary of main policies for conformity evaluation of generic drugs