Overview
Announcement of the highly anticipated Food and Drug Administration (FDA) guidance on electronic submissions for drug applications and related submissions appeared in the Federal Register (see 8 Fed. Reg. 10448 (Feb. 24, 2020)), Notice of Availability, "Providing Regulatory Submissions in Electronic Format – Certain Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7); Guidance for Industry." Manufacturers of drug packaging materials will be pleased to learn that Type III Drug Master Files (DMF) are now officially exempt from the burdensome electronic Common Technical Document (eCTD) formatting requirements described on the guidance.
The fate of Type III DMFs, which are the type of DMFs that apply specifically to drug packaging materials, has had a rather tortured history. The first version of the guidance was initially distributed in May 2015. This version specified that Type III DMFs were considered to be submissions to human drug applications (i.e., New Drug Applications, Abbreviated New Drug Applications, Investigational New Drug Applications, and Biologics License Applications) and, thus, subject to electronic filing requirements under section 745A9(a) of the Federal Food, Drug, and Cosmetic Act. Following discussions with the drug packaging industry, however, FDA became aware of significant issues and concerns surrounding mandatory eCTD filings for Type III DMFs. These ongoing discussions resulted in three separate extensions to the deadline for mandatory eCTD filings for Type III DMFs and, ultimately, under Section III.C. of the final guidance an exemption for these types of submissions. This is very welcome news for the drug packaging industry and will facilitate the continued supply of packaging materials for human pharmaceuticals.
