Are You Prepared for eCTD Submission?

Klaus Menges, Division of Strategy and Planning, at the Federal Institute for Drugs and Medical Devices, BfArM, joins Pharma IQ, to discuss successful strategies for eCTD submission. To listen to the podcast now go to Successful Strategies for eCTD Submission.

Pharma IQ:
Ensuring eCTD readiness is now critical for all businesses wishing to gain first time market approval – what would you say are the main advantage of using the eCTD?

K Menges: There are several advantages you can achieve. For instance, for our internal business, the reduction of paper flow, which also may be relevant for industry; the reduction of physical archiving space for agencies and industry as well. The facilitation of the revenue process – that is mainly done for us; and also the content and document reuse is, again, for industry and agencies as well. In summary, the eCTD will be a process driven management and exchange of information, and that’s much better than what we could achieve in the past.

Pharma IQ: What would you say is the biggest challenge for eCTD management?

K Menges: On the one hand, eCTD will need some standards on a regional and international basis; these standards are converging. There are still regional interpretations and these interpretations are, for sure, not converging straightforward enough. That is one major point we need to achieve for further development. For that, the eCTD submission standards will continue to change and develop. Therefore we need to understand the process behind it, and how to gather it, assemble and use this new way of handling on both the science industry and agencies.

Pharma IQ: What common errors were made to prevent submissions from being processed?

K Menges: There is a lack of respect for these standards at some point, for instance, not respecting the file and folder naming conventions, or not respecting the requirements for PDF documents. So there is no effort to comply with the XML backbone. There is an example available, or standards available, which is easy to achieve, but PDF publishing is a labour intensive step for e-submission in the process. We also published a number of requirements, how to achieve good PDF documents or useable documents, and that needs to be understood by industry. That is also a major concern by assessors that these PDF files are not well readable or useable for them, therefore to take care for this issue is perhaps the most important issue we can improve over time.

Pharma IQ: What would be your top three tips for ensuring first time submission?

K Menges: Make sure you can create the proper process and proper rules to get a well useable PDF document that is relevant and useful over time. When you create an eCTD submission you have to define the product structure, whether this should contain all strengths and forms, or should only contain one strength or one form. There is a dependency on how the eCTD will be structured from the start-up, and this will have an impact for maintenance and lifecycle management aspects. You should consider to be supported by experienced people when you create your first eCTD; also you should allow to wait some time for the first time of creating an eCTD; it will be costly in time, and you have to have enough time to create a proper eCTD.

Pharma IQ: Do you think it’s possible to make eCTD mandatory on a global scale?

K Menges: Personally, I think it is but it should be step-wise starting perhaps with new chemical entities, and on a second step for generics before making the eCTD mandatory for all other procedures. In fact, I would say, yes.

Pharma IQ: What is next, do you think, for the eCTD?

K Menges:The eCTD per se will remain, but perhaps as an implementation rule for human medicinal products, when we think about the regulated product submission standards currently under development on ICH and HL7 level. The technical solutions behind may change in a way to simplify the lifecycle management, to support lifecycle management in a better way, and perhaps to take advantage of the use of XML in a broader way, not only for the backbone, but also for documents.


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