CDE issued the draft of technical guidelines for bioequivalence research of chemical drugs and generic drugs in human body with pharmacokinetic parameters as the end point evaluation index

Source: CDE 2015-11-30 "technical guidelines for bioequivalence research of chemical drug generic human body with pharmacokinetic parameters as the end point evaluation index" notice for comments on the Internet In order to standardize the study on bioequivalence of chemical generic drugs in human body and ensure the quality and efficacy of generic drugs are consistent with those of the original drugs, the drug Audit Center established a special working group at FDA On the basis of relevant guiding principles, after preliminary writing and expert discussion, a draft of technical guiding principles for bioequivalence research of chemical drug generic human body with pharmacokinetic parameters as the end point evaluation index has been formed Now, the center's website is open for comments, and the deadline for comments is December 31, 2015 The overall idea of the guidelines is based on the technical guidelines of human bioequivalence test of generic drugs issued by FDA, and the actual situation of domestic regulatory requirements and test management system are comprehensively considered The core technical requirements of these guidelines are consistent with those issued by FDA We sincerely welcome the colleagues from the industry to give us valuable opinions and suggestions on this online draft and give us timely feedback so that we can do better in the follow-up work Your feedback can be submitted according to the following path: click the "guidelines for comments" column on the website of the center, click the "technical guidelines for the study of human bioequivalence of chemical drug generic drugs with pharmacokinetic parameters as the end point evaluation index", fill in your comments in the dialog box, and click confirm to submit You can also contact the contact person of the center directly: Li Li, Zhang Yuhu email: lil@cde.org.cn; zhangyh@cde.org.cn Tel: 68585566-15321538 thank you for your participation and support Appendix: technical guidelines for bioequivalence research of chemical drug generic human body with pharmacokinetic parameters as the end point evaluation index (Draft for comments) Docx