Publishing - eCTD
The move to the Common Technical Document (CTD) submission format, as defined by the relevant ICH Expert Working Group, has paved the way for a standardised global approach to providing regulatory authorities with scientific-technical information on the quality, safety and efficacy of a medicincal drug product. Its XML-based counterpart – the eCTD (Electronic Common Technical Document) – enabled efficient and rapid submission in electronic form over the internet, rather than having to print, bind and dispatch thousands of pages.
The eXtensible Markup Language (XML) was developed by the World Wide Web Consortium as early as 1998. It is a hierarchical markup language that allows data to be stored in a format that enables for a platform-independent storage, transport and sharing, either locally or over the Internet.
The ICH Electronic Common Technical Document Specification V3.2.2 defines the rules for creating an XML-based eCTD for CTD modules 2 to 5 (the common part of the CTD). The rules for the regional parts of the CTD (module 1) are specified in regionally different Module 1 eCTD Specifications, resulting in backbone instances such as eu-regiona.xml or us-regional.xml.
Additional requirements may be imposed by regional authorities, such as the need for study tagging files (STFs) to group preclinical and clinical study data and documents for submission of eCTDs to the US FDA. While the Portable Document Format (PDF) is the most commonly used format for data and document files, other file formats may be allowed in an eCTD regionally.
All these aspects need to be considered before an eCTD can be created and make e-submissions complex projects. They require appropriate IT infrastructure, digital (and regulatory) expertise and hands-on team experience, as well as standardised data management and workflow.
Phact is a specialist in eCTD publishing with many years of practical experience and offers all the necessary prerequisites for a smooth and successful eCTD submission.
Phact prepares eCTDs in accordance with regional requirements and assists its clients in the optimisation of their e-submission projects.
Do you have a question or need support?
To paraphrase a famous proverb: The submission of thousands of pages begins with a project plan.
Complex electronic submission projects, such as initial applications for marketing authorisation, require detailed and professional planning. Schedules, project participants, responsibilities, ressources and budgets must be defined in advance, monitored during the project and adapted to changing conditions.
With many years of experience in e-submissions, particularly in the EU and USA, we can provide expert support from the outset of your envisaged eCTD project.
Are you actually receiving “eCTD compliant” PDFs from your service providers, such as preclinical or clinical study reports, quality documents?
Correcting PDFs that do not meet the requirements for an eCTD is a significant time factor.
To name just a few common examples: Clinical studies may not have the required level of granularity, PDFs may be password protected, bookmarks or internal hyperlinks may be broken, PDF properties may not be set correctly.
We are ready to assist you with the pre-review and correction of your PDFs to ensure they are eCTD compliant.
When preparing a US eCTD, a number of specific requirements need to be considered. Some of these are briefly outlined below.
Study Tagging Files (STFs) are used to group and identify all files associated with a preclinical or clinical trial. STFs are a “must” in a US eCTD. They are accepted in an EU eCTD – but not allowed in a Japanese eCTD.
Preclinical and clinical study data (‘data sets‘) must be submitted as part of a US eCTD when applying for marketing authorisation. Apart from legacy datasets that may be provided in a non-standardised format, datasets must comply with study data standards such as those defined by the Clinical Data Interchange Standards Consortium (CDISC), a global non-profit organisation. Datasets are not currently required for EU-eCTDs, while the Japanese Pharmaceutical and Medical Devices Agency (PMDA) has adopted these standards.
As part of FDA’s Bioresearch Monitoring (BIMO) program, a set of standardised data on the sites and subjects enrolled in a clinical trial must be submitted as part of an eCTD when applying for marketing authorisation. This “BIMO data set” is used by the FDA to plan its BIMO inspections.
Cross application referencing, which allows applicants to submit required documents and data once and then reference them for subsequent eCTD submissions.
This feature is not allowed in EU-eCTDs, for example.
In short, if you need assistance with the preparation of your US-eCTD or have questions about any aspect of it, we are here to help.
We can support your publishing team – or we can produce the entire submission-ready eCTD for you.
Whichever you prefer.
We look forward to hearing from you so that we can discuss the solution that is best for you.
Do you have new members in your publishing team?
Do you want to update their knowledge – or share experiences?
We’d be happy to provide you with a quote for in-house training – whether face to face, virtual (web-based) or using hybrid learning formats. We look forward to hearing from you.
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