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  1. CDER Small Business & Industry Assistance (SBIA)

SBIA CHRONICLES PODCAST SCRIPT (9/22/2016)

FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions

Welcome to the CDER Small Business and Industry Assistance (SBIA) Podcast Series!

Today’s topic is regulatory submissions that must conform with the FDA’s electronic Common Technical Document format.

The FDA now requires that certain regulatory submissions conform to the electronic Common Technical Document format. In addition, study data will have to be submitted in a standardized format for certain studies.

The electronic Common Technical Document or “eCTD” has been the standard format since 2008 for submitting applications, amendments, supplements and reports to FDA’s Center for Drug Evaluation and Research or CDER and Center for Biologics Evaluation and Research or CBER.

Electronic submission makes it easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market. The eCTD format also simplifies the process for submitters because it is used by many other drug regulatory agencies. Starting in 2017, eCTD will be required for applications submitted to CDER and CBER. 

Beginning May 5, 2017, submitters MUST use eCTD for:  New Drug Applications  or NDAs, Abbreviated New Drug Applications or ANDAs, Biologics License Applications or BLAs, and 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. 

Beginning May 5, 2018, submitters MUST use eCTD for commercial IND submissions. Non-commercial IND submissions including investigator-sponsored INDs and expanded access INDs are exempt. 

The requirement for commercial INDs for products that are intended to be distributed commercially starts after December 17, 2017. Data from studies starting before December 17, 2016 need not be converted to comply with the standards.

After these deadlines, paper submissions or electronic submissions that are NOT in the eCTD format will NOT be filed or received unless exempt from the requirement. There are no waivers to the eCTD format.

Electronic submissions must include FDA fillable forms and electronic signatures to enable automated processing. Fillable forms are fillable on the computer, which makes it easier to process them electronically. Non-fillable forms and scanned images of FDA forms will NOT be accepted.

Details for submitting applications in the eCTD format are provided in the Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

The eCTD website contains the relevant guidances and eCTD technical specifications, along with a step-by-step guide to setting up an Electronic Submissions Gateway account and an eCTD web-based learning course.

Study Data Standards will provide a consistent general framework for the organizing  of study data, including templates for datasets, standard names for variables, and standard ways of doing calculations with common variables. Data standards facilitate application reviews and bring uniformity to assessments of drug safety and efficacy. Standardized data at all levels of the drug lifecycle will enable researchers to better capture data and answer new questions about medicines and health.

The FDA Data Standards Catalog located on the Study Data Standards Resources page, is a spreadsheet that provides a listing of supported and/or required standards, their uses, the date FDA will begin or has already begun to support a particular standard, and the date support ends or will end. It also provides the date the requirement to use a particular standard will begin or has begun, the date such requirement ends or will end, and other pertinent information.

In addition, FDA has a Study Data Technical Conformance Guide, which provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog.

Sponsors submitting studies to CDER or CBER after December 17, 2016 must use the data standards listed in the FDA Data Standards Catalog for: 

  • NDAs, ANDAs, BLAs
  • And for 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.

The FDA may refuse to file NDAs and BLAs, or refuse to receive ANDAs if an electronic submission that contains study data does not conform to the required standards specified in the FDA Data Standards Catalog.

FDA’s Study Data Standards Resources webpage contains FDA’s most recent versions of FDA’s Data Standards Catalog, guidance documents, and technical specifications. Exemptions are discussed in FDA’s Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Standardized Study Data.

We strongly encourage sponsors to plan for the implementation of the eCTD standard format now, and to consider the use of data standards for the submission of applications as early as possible in the product development lifecycle, so that data standards are accounted for in the design, conduct, and analysis of studies.

A link to the full SBIA Chronicle article and more information about CDER’s SBIA Program can be found at: www.fda.gov/cdersbia. Thanks for tuning in!