About eCTD
What is it?
The electronic Common Technical Document or eCTD defines a hierarchical cabinet that provides a structure (in XML format) to display regulatory documents in PDF format. Metadata associated with each document describe the subject matter and eCTD submission sequence to facilitate life cycle management. There is no difference between a paper-based CTD and eCTD in terms of its organisation in modules and sections or in the regional scientific, technical and clinical content requirements.
For many years industry and regulators have recognised the need for electronic submissions in order to reduce the administrative, financial, logistical and environmental burdens that are currently imposed by providing paper-based submissions. As a result, the eCTD specification was developed by the International Conference on Harmonisation (ICH) and is the international standard for submission of regulatory documents currently recognised by health authorities in the EU, USA, Canada and Japan.
In contrast to paper-based CTD submissions, life cycle management of regulatory documents is integral to the eCTD standard. Each submission is allocated a sequence number that enables the eCTD to be maintained in a current state such that the currently registered information can be readily accessed along with a detailed history of all changes made since the initial application. Furthermore, the eCTD is bookmarked, hyperlinked and text searchable for ease of navigation and to facilitate the review process.
Will I need it?
Yes. Currently, the TGA strongly encourage submission of dossiers using electronic media (in addition to paper copies). As part of the recent Business Process Reforms, the TGA have begun moving towards eCTD implementation and have released draft guidances including "Australian Module 1 Specification" and their "Guidance for Industry on Providing Regulatory Submissions for Prescription Medicines in Electronic Format (eCTD) in Australia". Once implemented by the TGA, it is expected that a transition period, allowing the submission of paper and eCTD dossiers will follow. It is then expected that submission of eCTD dossiers will become mandatory, consistent with agencies in Europe, Canada and the USA.
Apart from becoming mandatory, implementation of eCTD affords additional benefits including:
- Ease of agency review of your dossier and potentially shorter review times therefore decreasing time-to-market
- Seamless ability to ‘clone’ submissions prepared for one region for submission in another
- Enables the generation of the submission during drug development, provides time and cost savings by getting a head start on the market application
- Simplified solution for regulatory compliance since the eCTD is designed to be maintained throughout the life cycle of your product and will always reflect the currently registered information whilst retaining an archive of changes
Getting the right eCTD solution...
There are several solutions your company should consider:
- Outsource your entire eCTD submission to Pharma To Market.....more
- Software-as-a-Service or SaaS: Receive training and use eCTD software to prepare your eCTD submissions only when you need to. The software is hosted externally on a validated and secure environment....more
- Internally Hosted Solution: Purchase, implement and validate eCTD software and train your personnel on its use....more