eCTD (electronic Common Technical Document) submission is an extremely complex process, which means it helps to be prepared.
When submitting regulatory information such as applications, reports and supplements in this standard format, the documents and cross-links required have to be technically accurate to ensure your submission can go ahead without unnecessary delays and be on its way to approval.
With a 100% eCTD technical approval rate, the ONIX team certainly knows what it takes to avoid the mistakes that can slow eCTD submission down. Our in-depth knowledge and experience have helped us advise countless clients on best practices and the latest regulatory developments to enable them to get ready for eCTD submission and find success.
In this blog post, we take a closer look at the steps you should take to prepare for eCTD submission.
Understand why an eCTD is the standard
For those unfamiliar with the use of eCTDs in the pharmaceutical industry, it helps to delve deeper into their background. The FDA details why an eCTD is the standard form of submitting regulatory applications and reports to health authorities around the world:
“When materials are submitted electronically, it is easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market. Using eCTD also simplifies the process for submitters, because it is the same format used by drug regulatory agencies in other countries.”
Consisting of five modules in total – namely region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports – an eCTD helps all parties build and maintain a knowledge base for drugs, herbal, veterinary and medical devices.
Delve into specific requirements
Whilst an eCTD may be a standard format, the requirements that need to be met from health authority to health authority are not. Depending on the health authority you will be submitting your eCTD to, you will have to satisfy varying regional requirements, with key differences found in module 1 and the validation criteria.
You’ll also find a string of requirements that need to be met technically, including the use of links via XML Backbone and the formatting of PDFs. How your eCTDs are configured for previewing; scanned for electronic management; and hyperlinked, bookmarked and numbered is also subject to a range of best practices.
Don’t fall foul of common mistakes
With so many technical requirements to fulfil, it’s no surprise that a large number of organisations fall at the first hurdle without professional support from us. There are a number of common mistakes to avoid when submitting eCTDs, but with planning, organisation and research, you can steer clear of technical rejections.
Access the right tools and support
You don’t have to take on eCTD submission alone. By implementing the right tools for eCTD compliance and accessing professional support, you can ensure your data and documents are in tune with the latest submission standards and requirements. By enlisting us, you can also adjust your processes as regulatory rules change to maintain your eCTDs long into the future.
Get in touch with our team today to find out more about how we can help with eCTD submission and management.
