Successful review of eCTD submissions at health agencies

When agencies introduce eCTD into their country, they need to ensure that they implement a submission review system to effectively manage the review of eCTDs.

By Maren Müller & Dr. Silke Nolkemper, EXTEDO

The move from paper-based to electronic eCTD submissions involves a substantial change in the way that your agency needs to handle dossiers provided by applicants. In the paper world, technical validation of submis­sion content is not required, but in the electronic world content and data needs to be verified to ensure that the correct information is present and that it is provided in the mandated formats. When agencies introduce eCTD into their country, they also need to ensure that they implement a submission review system to effectively manage this.

As this is a business critical application, ensuring the highest quality and availability of the eCTD review system is essential. Software should be chosen that has a proven track record and multiple similar successful deployments worldwide.

From paper to eCTD – what is the motivation for a health agency

  • Comply with international regulations
  • Reduction of physical paper flow and storage space
  • Electronic access to the entire lifecycle of a product
  • Ready access to the status of documentation
  • Easy browsing and review of dossiers
  • Simultaneous access for multiple reviewers to the dossiers/documents
  • Allows comparison of two versions of a document to see changes immediately
  • Easy creation of assessment reports via copy & paste or export of annotations
  • Better integration to existing 3rd party systems (Portal/ Case Management Tool / WF/ Email)

How does the review process take place within the agency?

The switch from paper-based to electronic submission and review processes requires some changes in the business of an agency. Additional process steps, workflows and tasks come along with this switch as well as new roles, including employees that are responsible for validation and import of an eCTD submission into the review software. The software should provide the agency with tools for the validation, acceptance, import, review and maintenance of eCTDs and give complete confidence that they conform to the official standards.

Independent of the way an eCTD submissions is sent to a health agency, before it can be accepted and further processed in the system, the submission has to be validated according to the validation rules of that respective country or region. The technical validation and import into the system can be done manually by a designated department within the agency. Alternatively, it can be automatically processed by the review software and additional components. Also, the way an eCTD submission finds its way from the applicant to the agency might be different. Most agencies worldwide receive submissions on CD/DVD or other portable devices. But there are also agencies like the EMA who have established a portal where the applicants can upload their submissions and send them in a purely electronic way, without any physical transfer medium. This has the advantage that the review software can be connected directly to the portal and all the stages of validation and import can be controlled by the system. As the validation of large numbers of submissions can require a significant investment in both time and resources, it quickly becomes a bottleneck. Automated processes can help to avoid this, ensuring increased operational efficiency and further streamlining the validation process. In the instance that a submission is invalid, the applicant is presented with a report and must submit the corrected submission again. Only valid submissions will be imported into the review system.

Once a submission is successfully imported into the system, the reviewers responsible for the assessment of the product are automatically informed. They can then start the review of the parts they are responsible for (business validation). It is possible for information about new tasks to be sent to reviewers manually by the people team responsible for the import. However, by using a Case Management Tool with integrated workflows, routine daily tasks can be automated and messages sent automatically to those responsible.

Reviewers can now easily access documents in the modules that they have to evaluate, for example, quality procedures or the information about clinical trials. The review system allows quick access to all relevant information through full text-search and filtering based on relevant criteria. These criteria could include things such as regulatory activities corresponding to the overall regulatory status of a drug product. Imported submissions can be viewed and annotated directly through the review software.

The main advantage of an electronic review system is that, once uploaded, submission reviews can be performed by multiple assessors simultaneously. This reduces timelines enormously, as one assessor does not have to wait for another one to finish their work before they can commence their own tasks. Hyperlinks and bookmarks in the documents speed up the assessment as well, as related information in other documents can be found much faster. Full screen mode can be useful for evaluating figures and tables that are a small font size. The assessor can make annotations in the documents, either for themselves, for other reviewers or as final comments for the applicant. These final annotations will then be directly exported into a specific template and combined together into an assessment report, ready for sending to the applicant. The applicant must then send his answer through a new eCTD sequence with replaced or new documents.

Later in the lifecycle of a product, i.e. in follow-up submissions, different versions of documents can be readily compared. Assessors can quickly see if all obligations were fulfilled by the applicant, e.g. new data added or other corrections made to the document. At any time, the whole history of an electronic dossier is available for every user. As eCTD dossiers always keep all previous versions of documents available in the system directly, searching in a paper archive is no longer necessary.

Reviews can also be made by remote participants, ensur­ing that all parties can access the submission content wherever they are located. Offline mode may be used if a reviewer wants to make the assessment while travelling or if for any other reason they are not connected to the system. There is no longer a need to carry hundreds of pages of paper from one office to another, but in the event that you do need a paper copy, this can easily be printed from the system.

It is often the case that some of your reviewers are not direct agency staff, they work only part time as an evaluator. In these instances, it is useful to have a lightweight interface that is easy to learn and requires minimal training. A web interface is often preferred by most users. These provide the ideal solution for collaborative working between agency staff and external assessors in situations where IT resources may be limited.

Summary

The switch from paper-based to electronic review of drug applications will require changes in your current processes and training to familiarize users with any new software. However, it also brings with it many advantages; simultaneous access to documents, detailed dossier histories, easy navigation via hyperlinks and electronic search. Over a relatively short period of time, these advantages significantly outweigh the initial investment in time and effort. By choosing the right, well designed software, you will be able to simplify and optimize the review and validation of regu­lated electronic submissions within your agency. The result will be reduced assessment timelines, faster approvals and, in the end, faster access to new drugs for patients.

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