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Aligning with all the global health authorities, the Jordan Food and Drug Administration (JFDA), too, has started accepting marketing authorization submissions in electronic common technical document (eCTD) from March 1, 2019. The new format – JO eCTD Format – has similar elements of other health authorities eCTD formats? Obviously not.
To make sure the applicants understand all the intricacies of JO eCTD format, the JFDA has recently released a guidance document, “Jordan Module 1 eCTD Specification Version 1.0.2.” Detailing the instructions about submission compilation, the guidance comprises the following aspects in a specified order:
- General considerations
- Regional file formats
- Instruction to handle empty or missing eCTD sections
- Technical information
- General architecture of Module 1
- Business protocol
- Change control
- Instructions for extension submissions
- Reformatting
- Universally unique identifier
Additionally, the JO eCTD specification is designed to support high-level functional requirements, as listed below:
- Copy and paste of information
- Viewing and printing of documents
- Annotation of documentation
- Facilitating export of information to file shares and databases
- Searching within and across the applications
- Navigating throughout the eCTD and its subsequent amendments/ variations
The Guidance is Aimed At:
The guidance helps applicants of both initial marketing authorizations and approved authorizations. Special instructions are laid out in the guidance for applicants of approved authorizations to compile a baseline submission in eCTD. Further, the guidance also provides examples for submissions and other auxiliary instructions in five appendices.
With the changes to the existing guidance and JO eCTD regulations are expected, as informed by the JFDA, the applicants are required to map the Regulatory proceedings of submission process before in hand. Either a global eCTD expertise or a robust eCTD submission tool is what applicants should look for to have an edge over handling the submissions efficiently and compliantly. Gear up with the right-first-time approach. Be compliant.
