It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.”
This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The objective of the guidance was to make it easier for the FDA to review data, approve new drugs, and perform post-market surveillance, as well as to simplify the regulatory process.
In a revised version of this guidance released on April 7, 2017, the FDA extended the compliance deadline for Drug Master Files (DMFs) due to challenges with submission of master files in eCTD format. However, the guidance went into effect on May 5, 2017, for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs).
As of May 5, 2018, Commercial Investigational New Drug Applications (INDs) and DMFs must be submitted using the eCTD format using the FDA’s Electronic Submissions Gateway (ESG). The only exception is Type III DMFs, for which the FDA has extended the implementation date to May 5, 2019. The rationale behind the extension for Type III DMFs includes:
- Application of the electronic submission requirement on May 5, 2018, could lead to high rejection rates of these submissions
- These files typically provide information regarding packaging or packaging materials in support of NDAs, ANDAs, or BLAS, and choosing not to submit or to no longer support existing Type III DMFs could lead to interruptions in drug supply
- Only a small portion of Type III DMFs require assessment by FDA staff in support of a marketing application
What you need to know about eCTD filing
Mandatory electronic submission requirements now apply to:
- NDAs
- ANDAs
- BLAs
- Commercial INDs
- All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
- Master files, such as DMFs, which are considered submissions to an application
Electronic submissions are encouraged, but optional, for:
- Non-commercial INDs, such as investigator-sponsored INDs and expanded-access INDs
- Submissions for blood and blood components
- Submissions for promotional materials related to human prescription drugs
An eCTD submission has five modules:
- Region-specific information
- Summary documents
- Quality-related information
- Non-clinical study reports
- Clinical study reports
So that’s what you need to know about the May 5, 2018, deadline. Now the work of getting it through the electronic submission process begins!
From obtaining a pre-assigned application number to ensuring that your documentation are in accordance with FDA PDF Specifications and other submission standards, our regulatory submissions teams at Premier can help get you through the gauntlet – contact us now!