• FDA Puts out Guidance to Require Submissions in ICH’s Electronic Format for Certain Pharmaceutical Product Applications Within Two Years
  • June 16, 2015 | Author: Scott S. Liebman
  • Law Firm: Loeb & Loeb LLP - Washington Office
  • The regulator issued guidance in accordance with the FDCA that outlines Electronic Common Technical Document (eCTD) specification requirements for submissions of new drug or biological products, requiring that all submissions be done electronically and in the ICH-developed format within the next two years.

    The eCTD is an ICH format based on specifications developed by the initiative and its members, and the FDA’s CDER and CBER have received eCTD format submissions since 2003. The format has also been the recommended format for electronic submissions to the CDER and CBER since 2008, with the majority of new electronic submissions being received in eCTD format.
    Section 745A(a) of the FDCA states that two years after guidance specifying the electronic format for submissions is issued, submissions must be submitted electronically and in the format specified by the agency. The regulator is thus putting out the document to announce that submissions for NDAs, ANDAs and certain BLAs will need to be submitted electronically using the eCTD format beginning within the next two years, while IND application requirements will come into effect after three years.

    The document, along with included technical specification documents, describes how to organize and submit content in electronic format using eCTD specifications listed in the FDA Data Standards Catalog.

    The FDA’s guidance document goes over electronic submission requirements, covering types of submissions, the implementation schedule and exemptions. Also explained are the eCTD specifications, presubmission considerations and submission structure, including granularity, files and folders. The FDA goes on to specify file formats and versions, document life cycle, summary of clinical efficacy and safety, data sets and study information, and the transmission of electronic submissions. The document ends by going over FDA forms, restrictions on paper copy submissions and receipt dates.