FDA issues draft guidance for the submission of manufacturing establishment information

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The FDA has released a draft guidance "Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information", dated December 2016.

This guidance specifies the electronic submission format and implementation timelines for Manufacturing Establishment Information (MEI) submitted in the context of NDAs, ANDAs, BLAs and referenced DMFs. It covers also lifecycle submission activities such as amendments, supplements or resubmissions. Therefore this guidance should be read together witht the overall electronic submission guidance "Providing Regulatory Submissions in Electronic Format — Submissions Under Section 18 745A(a) of the Federal Food, Drug, and Cosmetic Act".

The MEI encompasses:

  • Establishment name and address: Specific information regarding the physical location (e.g., building number on a corporate campus or industrial complex).
  • Unique Facility Identifier
  • Contact information for the person responsible for scheduling inspections.
  • Specific manufacturing operations being conducted.

The file format for the electronic MEI follows the HL7 Version 3: SPL format (check here).

The MEI file should be filed in section 3.2.R Regional information of the eCTD. Redundancy to similar information in section 3.2.S.2.1 Manufacturer(s) [Drug Substance] and/or 3.2.P.3.1 Manufacturer(s) [Drug Product] should be avoided. Therefore, applicants should simple linke the single file located under 3.2.R from these sections.

[Source: FDA]

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