In December
2016, FDA issued a draft guidance regarding the electronic
format for submission of Manufacturing Establishment Information (MEI).
NDAs, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types will have to be submitted electronically in the format specified within the draft guidance twenty-four months after it is finalized.
NDAs, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types will have to be submitted electronically in the format specified within the draft guidance twenty-four months after it is finalized.
FDA is
proposing to mandate that applicants consolidate
the MEI into a single list of information, in contrast to the current
practice of filing MEI in multiple locations within a CTD. Highlighted
requirements include:
- The MEI file must be included in eCTD Module 3, section 3.2.R Regional information.
- Applicants must name the file, “establishment-information-[Date of the submission (YYYY-139 MM-DD)].xml” with a corresponding leaf title of “Establishment-Information-[Date of the 140 submission (YYYY-MM-DD)].
- To avoid redundancy, the following “Manufacturer” sections must simply link to the single 3.2.R Regional file described above, and no other files may be submitted at these locations:
- 3.2.S.2.1 Manufacturer(s) [Drug Substance]
- 3.2.P.3.1 Manufacturer(s) [Drug Product]
Contact RPI to ensure your readiness to meet FDA’s forthcoming requirements.