4DMF for AAPSCPA Worshop V3.ppt

Outline Drug Master Files in the US Comparison of US DMF, European ASMF and CEP RDPAC Proposal for DMF in China Drug Master Files in the US What a DMF is and is not Types of DMFs Electronic filing and CTD-Q Administrative information Technical information by type of DMF Review process Technical amendment process Interaction between FDA and DMF holder during DMF review Issues of concerns for drug manufacturers Remarks What a Drug Master File is and is not A Drug Master File (DMF) is a submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs The submission of a DMF is not required by law or regulation. A DMF is submitted solely at the discretion of the holder. A DMF usually covers manufacturing information not considered releasable via a Freedom of Information Act (FOIA) request There are no “Open” and “Closed” parts of a DMF What a Drug Master File is and is not (cont’d) The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), another DMF, Export Application, or amendments and supplements to any of these A DMF is not a substitute for an IND, NDA, ANDA, or Export Application Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application DMF is not approved or disapproved FDA will determine if its technical content is acceptable or deficient in support of the related application If deficient, a letter is sent. If acceptable , no letter is sent. Types of DMFs* Type II: Drug substance, drug product, intermediates, and material used in their manufacture Type III: Packaging material Type IV: Excipients, colorant, flavor, essence, or material used in their preparation Type V: Other reference information accepted by FDA e.g., sterile manufa