ANDA据收标准.ppt

FDA Draft Guidance ANDA Submission Refuse to Receive Standards ANDA 拒收标准 Background ? GDUFA mitment for improving quality of ANDA submission ? Benefit: improve the efficiency of the reviewing process ? 497 ANDA were refused to receive between 2009 and 2012 ? 12% in 2009 ? 18% in 2010 ? % in 2011 ? % in 2012 (100 ANDA) 40 were due to serious BE inadequacy 36 were due to serious chemistry deficiency 13 were due to eCTD format flaws 6 were due to clinical deficiencies 4 were due to inadequate microbiology information 1 were due to incorrect reference listed drug (RLD) FDA ’ s ANDA Checklist ? The checklist is used by the FDA to assess completeness and acceptability ? The checklist outlines the essential statutory and regulatory requirements ? The checklist is updated quarterly and can be downloaded from the FDA website Important: always work with the most up to date version. General Policy ? ANDA contains < 10 minor deficiencies ? FDA notification is by phone, e-mail or fax ? Must respond within 5 business days ANDA is received on the original submission date ? If not responded, FDA will refuse to receive ? ANDA contains > 10 minor deficiencies or > 1 major deficiencies ? FDA will send a letter refusing to receive the ANDA ? Resubmission is considered a new ANDA A new GDUFA fee applies (US$63860 for 2014) A. Form FDA 356h (356h) ? Listing of facilities (all must be US registered) ? Drug substance production facility (fee applied) ? Drug Product production facility (fee applied) ? Bioanalytical site (no fee) ? Clinical anization (no fee) ? Contract analytical site (no fee) ? Contract packager site (no fee) B. Organization/Format ? Must follow eCTD format ? Include a statement that a letter of non- repudiation is on file with FDA to validate electronic signatures ? PDF files must be converted from MSWord, not scanned documents ? Files must be appropriately bookmarked ? ANDA submitted as a single, continuous, unbookmarked PDF file will be refused C.