(Audio Podcast Transcript)
Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series. Today’s topic: Submitting Master Files in eCTD Format: When and How to Comply.
The FDA is extending the deadline for companies filing master files and all documents submitted to existing master files, in the electronic Common Technical Document (or eCTD) format from May 5, 2017 to May 5, 2018. This gives companies an extra year to comply with the new electronic submission requirements.
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
The compliance date for electronically submitting new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) remains unchanged.
FDA considers master files to be submissions to an NDA, ANDA, BLA, or an investigational new drug application. A drug master file or DMF may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
The requirement to submit DMFs using the eCTD format is part of FDA’s overall effort to review drug applications more efficiently. eCTD standardizes how industry submits applications, amendments, supplements, and reports and implementing electronic DMFs will improve the standardization of the DMF review process.
FDA recognizes that industry has had challenges submitting master files in eCTD formatand data suggests that adhering to the May 5th, 2017 date could have led to high rejection rates of master files. This would have slowed FDA review processes and led to unnecessary delay in the review of some drug applications.
After the new May 5th, 2018 deadline, all documents submitted to the DMF, for example amendments, annual reports, or letters of authorization, must be in eCTD format. If you are updating part of a DMF, you only need to provide the new information in the eCTD format. After May 5th, 2018 there will be no waivers or exemptions for DMFs that are not submitted in eCTD format.
DMF holders must submit all subsequent submissions electronically after the initial electronic submission. More information can be found in FDA’s Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.
Briefly, the steps involved in the electronic submission process are:
- Obtain a Pre-Assigned Application Number.
- Convert your DMF to eCTD Format: The eCTD format is composed of five modules, which provide structure for the submission and guide submitters where to place information. Submit electronic submissions using the Data Standards Catalog, which is the version of eCTD currently supported by FDA.
- Set up an Electronic Submissions Gateway (ESG) account: The ESG is the central transmission point for sending information electronically to FDA. Setting up an ESG account is a multi-step process and can take several weeks, so start the process well before you intend to make your first electronic submission. The process includes a testing phase designed to ensure that the FDA ESG can successfully receive your electronic submission and that the electronic submission is prepared according to published guidelines.
- Send a sample submission to FDA: Submitting a sample eCTD or standardized data sample is optional, but doing so can provide valuable feedback. Be sure to submit the sample early to allow time for adjustments.
- Submit via ESG: Submissions of 10 GB or smaller must be submitted through the ESG. Most submissions fall within these limits. Submissions that are more than 10 GB may be submitted through ESG or on physical media, such as a DVD or USB drive.
- Convert your paper DMF to eCTD: If you currently hold a DMF in paper form, you are not required to resubmit previous content in eCTD format. However, you may convert an existing paper DMF into eCTD format if you wish. To do so, use the same DMF application number. If your existing number is four digits, add two zeroes to the beginning of the number to convert it to a six-digit format.
In addition to extending the deadline, the FDA has provided DMF holders with a number of resources to explain the eCTD format and submission process. Many of these resources, including guidances, webpages, webinars, and fact sheets are listed on our eCTD webpage at www.fda.gov/ectd, and are detailed in the CDER SBIA Chronicles print issue that accompanies this podcast.
Don’t procrastinate! Take advantage of all the FDA resources to learn about eCTD submission requirements and how to beat the deadline! If you have questions, contact CDER SBIA at firstname.lastname@example.org.
A link to the full SBIA Chronicle article and more information about CDER’s SBIA Program may be found at: www.fda.gov/cdersbia.
Thanks for tuning in!