viernes, 23 de septiembre de 2016

CDER SBIA Chronicles: FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions

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

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

The eCTD has been the standard format for submitting applications, amendments, supplements, and reports to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) since 2008.

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 the CTD format is used by drug regulatory agencies in many countries. Starting in 2017, eCTD will be required for applications submitted to CDER and CBER.  

Deadlines: Beginning May 5, 2017, submitters MUST use eCTD for:

  • New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (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. 
  • Master files, such as Drug Master Files (DMFs), which are considered to be submissions to an IND, NDA, ANDA, or BLA.
  • Combination products (if CDER or CBER is designated as the lead center).

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. 

After these deadlines, paper submissions or electronic submissions that are NOT in 
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 (e.g., 1571, 356h) and electronic 
signatures to enable automated processing of the submission. 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.

How to Submit in eCTD Format: Resources to help you prepare and submit applications in eCTD format to CDER include:

The eCTD website contains 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. You may (CDER) or (CBER) for additional eCTD related questions.

Study Data Standards provide a consistent general framework for organizing 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 begun) to support a particular standard and the date support 
ends (or will end), the date the requirement to use a particular standard will begin (or has begun) 
and 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.  It is 
intended to complement and promote interactions between sponsors and FDA review 
divisions. Sponsors and applicants must submit study data electronically for both clinical 
and nonclinical studies.

Deadlines: Sponsors submitting studies to CDER or CBER that start after December 17, 2016 
must use the data standards listed in the FDA Data Standards Catalog for:  
  • NDAs, ANDAs, BLAs
  • 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 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. Non-commercial IND submissions
(including investigator-sponsored INDs and expanded access INDs) are exempt. 

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 
Electronic Format - Standardized Study DataPlease contact (CDER)or (CBER) for additional information.

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.


Renu Lal, Pharm.D.

CDER Small Business and Industry Assistance

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