We have written extensively on issues relating to electronic publishing of submissions. In fact, Acorn Regulatory was one of the very first companies to embark on electronic publishing on behalf of client companies many years ago. As the eSubmission Roadmap continues apace we are now looking to the next deadline of January 1st 2019 when all regulatory activities in National Procedures (NP) will need to be completed in eCTD. NeeS submissions will not be accepted in any European Union member state after December 31st 2018 and, as a result, companies not already submitting in eCTD need to start considering their next steps.
Companies will need to start working to create their electronic Common Technical Document (eCTD) and as part of that they will need to access the creating their Baseline Submission. A baseline submission is highly recommended at the time of changing to eCTD as it gives the authorities a view inside eCTD of the previously approved documentation. This will enable assessment of all future variation submission to be more streamlined as all relevant documentation will be easily accessible.
What is a Baseline Submission?
A Baseline Submission is a submission of all current valid documents accompanied with a statement that the content has not change and that only the format has changed. For transparency purposes it is recommended that baselines are applied when there are no pending activities for the product.
What Is Contained in a Baseline Submission?
A Baseline Submission can consist of all 5 modules or as a more basic submission of just module 3. In addition, modules can be baselines separately. For instance, module 3 may be submitted initially and then modules 2,4 and 5 are submitted as a separate sequence.
Module 1 consists of the administrative information, i.e. cover letters etc. The cover letter of a baseline submission must state that the content has not changed and only the format to eCTD at has changed.
Module 2 highlights the integrated overviews of Quality, Nonclinical and Clinical or a combination of these elements.
Modules 4 and 5 contain all study reports.
Perhaps the most important module of all is Module 3- Quality. This module should include an up to date view of the submission. Hyperlinks are not necessary at this stage. Also, companies making a submission should remember that all information from the initial dossier needs to be included unless it has been updated by a regulatory process.
Document granularity of Module 3 must follow the guidelines set out in ICH M4 on the organisation of Module 3.
When considering the issue of granularity one should consider the likelihood of subsequent changes and the ‘portability’ of those changes across regions. Also, we recommend that companies would be mindful of future needs and to that end you should only replace or delete whole documents and not replace or delete sections or pages. Furthermore, you should mention information only once and never allude to the reasoning for submitting a document.
As Baseline Submissions become more prevalent following on from the retiring of NeeS, it is important to understand the effort required to create a brand new Baseline Submission. Creation of a Baseline Submission can be a time consuming task particularly for small and medium sized companies that may not have the personnel at hand to assist with its creation. That is where our electronic publishing team can assist you. We are currently working with many companies in creating their Baseline Submissions and developing a publishing strategy for their companies. A well-structured dossier can assist your company by expediting the approval process and enabling you to get your product to market in a more timely manner.
Talk to us today and find out how we can assist you with your electronic publishing and Baseline Submission needs.