ANDA据收标准.pptVIP

FDA Draft GuidanceANDA SubmissionRefuse to Receive Standards ANDA 拒收标准 Background GDUFA 2012 commitment 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 15.5% in 2011 9.4% 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 research organization (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. Non-Payment of GDUFA Obligations GDUFA ANDA f