What is an eCTD submission?
The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of modules, sections, and documents to be used by an Applicant for a Marketing Authorization for a medicinal product for human use agreed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
While the table of content is consistent with the CTD, the eCTD also provides a harmonized technical solution to implementing the CTD electronically. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone, and with the file’s integrity guaranteed by the MD5 Checksum.
While most applicants opting for paper submission can opt for a CTD submission, most of the regulatory authorities including the United States (US Food and Drug Administration or USFDA) and Europe (European Medicines Agency or EMA) require mandatory submission of almost all applications in the eCTD format. So, if you are an applicant registering a product, be it a pharmaceutical, biological, medical device, or veterinary product, the eCTD format will be mandatory for regulatory submission.
The eCTD submission is composed of the following:
XML eCTD instance
This FDA guide gives detailed eCTD backbone guidance to applicants for file structure, file names for an eCTD submission as well as acceptable file formats for Module 2, 3,4, and 5 for USFDA, while Backbone Files Specification for Module 1 gives detailed structure and acceptable file formats for regional information for USFDA.
One of the examples of Module 3 backbone is indicated below:
The common formats that can be included in an eCTD submission are:
Narrative: Portable Document Format (PDF)
Structured: Extensible Markup Language (XML)
Graphic: Whenever possible, use PDF.
Regulatory applications applicable to the eCTD submission:
For submission to USFDA: The eCTD is the standard format for submitting applications, amendments, supplements, and reports for drugs and biological products to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) respectively. The eCTD is required for:
- Certain investigational new drug applications (INDs)
- New drug applications (NDAs)
- Abbreviated new drug applications (ANDAs)
- Certain biologics license applications (BLAs)
It is also important to note that the electronic submission requirements do not apply to submissions such as expanded access INDs and protocols for individual patients, including for emergency use; expanded access INDs and protocols for intermediate-sized patient populations; and expanded access treatment INDs and protocols and these can be submitted in the CTD format.
For submission to EMA:
The eCTD format is mandatory to use for all submission types related to Marketing Authorization for products within all EU procedures i.e.
- Centralized procedure: human medicines containing a new active substance to treat:
- human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
- neurodegenerative diseases;
- auto-immune and other immune dysfunctions;
- viral diseases.
- medicines derived from biotechnology processes, such as genetic engineering;
- advanced-therapy medicines, such as gene therapy, somatic cell therapy, or tissue-engineered medicines;
- orphan medicines (medicines for rare diseases);
- veterinary medicines for use as growth or yield enhancers.
- Decentralized procedure:
- Mutual Recognition Procedure
- Stepwise introduction for National Procedures.
The eCTD format ensures an efficient regulatory submission electronically, easier data exchange between the applicant and regulatory authority, and document management for the applicant through design and structure.
PSC Biotech® has in-house regulatory expertise and offers expert guidance and support with respect to managing your global regulatory submissions and drafting the eCTD Modules (Module 1 to Module 5) as well as navigating all the regulations pertaining to your product.
PSC also offers regulatory services in terms of drafting a regulatory framework and strategy, formatting, and publishing the eCTD Modules. Contact PSC Biotech to manage your submissions efficiently!
Useful References and Links for eCTD submission:
- eCTD submission standards, guidelines for USFDA: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-resources
- eCTD for USFDA: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd
- eCTD backbone specifications for Module 1 for USFDA: https://www.fda.gov/media/159382/download
- eCTD backbone specifications for Module 2 to 5 for USFDA: https://www.fda.gov/media/159380/download
- eCTD EU Module 1 Specification EU Module 1 v3.0.4(April 2021)
- The EU Harmonised technical eCTD guidance version 5.0(December 2021)
- The EU Harmonised technical eCTD guidance version 4.0
- eCTD validation criteria v7.1
- Variations in eCTD format Q&A document covering practical issues for variations in eCTD format
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