May 5, 2018 is the compliance date for submitting many types of files to the Food and Drug Administration in the electronic Common Technical Document (eCTD) format

May 5, 2018 is the compliance date for submitting many types of files to the Food and Drug Administration in the electronic Common Technical Document (eCTD) format

While the Food and Drug Administration (FDA) recently announced that it is extending the compliance date for submitting Type III drug master files (DMFs) in electronic common technical document (eCTD) format by one year to May 5, 2019, other eCTD deadlines remain unchanged. FDA is encouraging sponsors to make sure they are submitting DMFs (other than Type III DMFs) and Commercial INDs in the eCTD format by May 5, 2018. Files not submitted in eCTD after May 5, 2018 will be rejected. 

The requirement to submit DMFs using the eCTD format is part of FDA’s overall effort to more efficiently review drug applications. eCTD standardizes how industry submits applications, amendments, supplements, and reports. 

The FDA has a number of resources to help submitters understand eCTD format and how to submit using eCTD:

• Guidance Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document (eCTD) Specifications

• Drug Master Files (DMFs) webpage

• Fact sheets:
• New Requirements for Electronic Submissions of DMFs 
• DMF Tip Sheet 
• eCTD Submission Requirements: What You Need to Know
• FDA Electronic Submissions Gateway
• Getting Started: Creating an ESG Account

• Recorded webinars and courses:
• Stay Compliant! Electronic Submission of Drug Master Files (DMFs): What You Need to Know—August 4, 2016
• New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know – February 4, 2016
• Common Technical Document (eCTD) Course