Guidelines for conformity assessment of generic drugs at home and abroad

Background: as a large country of generic drugs, most of the approved chemicals in China belong to generic drugs, and the quality of these generic drugs is uneven, and some of them are far from the international advanced level In order to improve the quality of generic drugs, since 2012, SFDA has carried out a series of generic drug consistency evaluation work, which has made the generic drug consistency evaluation a hot topic in recent years In recent opinions (Draft for comments) on the consistency evaluation of generic drug quality and efficacy, it is required that the chemical generic oral solid system in the national basic drug catalog (2012 version) be developed The consistency evaluation of pharmaceutical products needs to be completed before the end of 2018, or the approval number will be cancelled, which also makes the consistency evaluation of generic drugs a big test for enterprises The consistency evaluation of generic drugs includes the study of dissolution in vitro and bioequivalence in vivo At present, it is mainly based on the dissolution test in vitro, and the bioequivalence in vivo should be evaluated later Therefore, in the face of a large number of drugs that need to be evaluated for consistency, it is the key to effectively obtain the latest policies, advice and guidelines at home and abroad The following is the search results obtained by inputting "consistency" or "dissolution curve" or "reference" keywords through the drug intelligence data policy and regulation database (http://db.yaozh.com/policies), including the relevant consistency research information of the State Drug Administration, the drug Audit Center, the Chinese Academy of inspection and the FDA for reference Click on the title to view the full text: the release date of the title of the regulation issued by the Department of the State Food and Drug Administration on Soliciting Opinions on the evaluation of the consistency of quality and efficacy of generic drugs (Draft) (2015 No 231) November 18, 2015 by the State Food and drug Administration Notice of General Office of food and Drug Administration on Soliciting Opinions on selection and determination of guidelines for reference preparations of general oral solid preparations 2015.10.30 controlled response related to generic drug development guidance for Industry Food and Drug Administration of the United States (FDA) 2015.09.28 comparative analysis of the consistency evaluation of foreign generic drugs notice of CDE Electronic Journal on Seeking Opinions on the consistency evaluation method (Draft) of dissolution curve of metoprolol tartrate tablets notice of China Academy of inspection 2013.12.31 on Seeking Opinions on the consistency evaluation method (Draft) of dissolution curve of ambroxol hydrochloride tablets notice of China Academy of inspection 2013.12.31 notice on Seeking Opinions on principles for establishment of reference preparations for oral solid preparations (Draft) Notice on Seeking Opinions on evaluation method for consistency of dissolution curve of terazosin hydrochloride tablets (Draft) Notice on Seeking Opinions on evaluation method for consistency of dissolution curve of nevirapine tablets (Draft) Notice on December 31, 2013 Notice on Seeking Opinions on guiding principles for determination and comparison of dissolution curve of general oral solid preparations Notice on the research task of quality consistency evaluation method of generic drugs notice of State Food and Drug Administration on carrying out quality consistency evaluation of generic drugs notice of State Food and Drug Administration on February 16, 2013 Notice of the registration department of the State Food and Drug Administration on Soliciting Opinions on the work plan for quality consistency evaluation of generic drugs (Draft for comments) on November 22, 2012 on the selection of reference preparations for bioequivalence test Problems needing attention in evaluating the similarity of dissolution curve by F2 factor method in CDE electronic journal in 2008 Note: the intellectual property rights of the above articles belong to yaozhi.com If you need to reprint, please indicate the source and the link of this article.