Notice of the Center for Drug Evaluation of NMPA on Issues related to the Implementation of ICH Guideline M9: Biopharmaceutics Classification System-Based Biowaivers and Q&A Document thereof
According to the NMPA Announcement, in order to well implement the ICH Guideline M9: Biopharmaceutics Classification System-Based Biowaivers and Q&A Document thereof (hereinafter referred to as M9 Guideline), upon the approval by National Medical Products Administration, the CDE is hereby notifying relevant issues as follows:
I. If M9 requirements are met according to the assessment by the applicant, the applicant can directly propose exemption of human bioequivalence test in the drug registration application. NMPA will not issue a separate catalogue of varieties exempted from human bioequivalence test or subject to simplified human bioequivalence test.
II. Applying for exemption from human bioequivalence tests shall be indicated in the application form. If the exemption cannot be made after evaluation, and the substantial defects cannot be corrected, the applicant will not be required to provide supplementary materials, and the registration application shall be disapproved.
III. In case of inconsistency between the previously issued Guideline for Exemption from Human Bioequivalence Tests and the M9 Guideline, the M9 Guideline shall prevail.
IV. The study data related to the exemption from human bioequivalence tests shall be submitted uniformly according to Module 220.127.116.11 of the current edition of M4: Organization of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use. The contents of application dossiers routinely required remain unchanged.