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FDA Permanently Exempts Type III DMFs for Drug Packaging Materials from eCTD Format Requirement

The Food and Drug Administration (FDA) has issued final guidance that exempts Type III Drug Master Files (DMFs), which cover drug packaging and drug packaging materials, from the requirement to submit in Electronic Common Technical Document (eCTD) format. The exemption is included in the final guidance for industry, titled, "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" (Revision 7), which FDA published this month. (See 85 Fed. Reg. 10448.)

The guidance describes how sponsors and applicants must organize the content that they submit electronically for all submission types to the Agency under section 745A(a) of the Food, Drug, and Cosmetic Act (FD&C Act). FDA initially issued guidance on submitting DMFs in eCTD format on May 5, 2015. That guidance specified that sponsors and applicants were required to submit various drug and biologics applications, and master files in support of such applications, in electronic format by certain dates, ranging from May 2017 through May 2018. The original deadline for submitting Type III DMFs in eCTD format was May 5, 2017; however, that deadline was extended for an additional 12 months and subsequently pushed back again to May 5, 2020 in a January 2019 version of the guidance.

The permanent exemption for all Type III DMFs from the eCTD submission requirement was initially proposed by FDA in draft guidance dated July 2019. At that time, FDA explained that submitters of Type III DMFs-drug packaging manufacturers and their material suppliers-are several steps removed from the drug or biologics applicants and that compliance with the eCTD format requirement, which would necessitate the purchase of expensive software, would significantly burden the pharmaceutical packaging industry. FDA added that drug packaging is often a limited portion of the packaging suppliers' overall business and that the burden on the Agency in allowing submissions of Type III DMFs in non-eCTD format is expected to be "reasonably low." Furthermore, FDA explained that the burden of a mandatory eCTD filing requirement could cause some packaging suppliers to exit the business altogether, which could lead to drug supply interruptions and drug shortages.

A copy of the final guidance exempting Type III DMFs from eCTD format requirements can be found here.