1. Valid submission according to EU validation criteriaThe first factor to consider when reviewing an eCTD dossier is technical validation. Before importing the dossier, ensure successful technical validation has been run on all sequences. Look to see the date of when this acquired dossier was started within eCTD. Older dossier structures may not be valid as per new validation criteria. It is important to consider this possibility when acquiring a licence. Re-run validation on any invalid sequences that were created prior to the eCTD current validation criteria set with earlier relevant versions available. This will help you in determining if any xml structure errors exist. Xml structural errors may cause issues when importing sequences into in-house eCTD software. Therefore, depending on the structural issues at hand a technical custom import may need to be considered.
2. Timing of moving from non-electronic format to eCTDFirstly, ask the question: when did this dossier start in eCTD? Was it started from the New MAA application or perhaps it was it started later post authorisation. If the dossier was transferred to eCTD post authorisation, then check if a baseline was ever submitted for this dossier. A baseline submission is recommended at the time of changing to eCTD. (Technical eCTD Guidance v4.0) It would be a compiled submission containing the approved licence dossier information that was submitted to the authorities prior to changing to eCTD.
3. Has the Lifecycle Management Been Maintained?Confirm that lifecycle management has been maintained. Request to see the current view. Look at the current view to determine what kind of a model is used? (i.e. single or comprehensive model) Is any work required to correct the existing lifecycle? Take notes of structure already in place. For instance, are the strengths combined or separated and are there node extensions or STF’s visible?
4. GranularityWhat kind of granularity has been done? Does it conform to the ICH granularity set out in the guidance? Are there any discrepancies to be seen regarding drug substance/ drug product sections of the dossier? Are there any structural issues that will prevent this licence from being incorporated into already existing internal procedures/processes for submitting future sequences? It is always best to consider these factors during negotiations so any issues can be discussed by both parties. The Acorn Regulatory eCTD specialists can help you with any of your eCTD or electronic publishing queries. Talk to us today by calling 00353 52 61 76 706 or complete the details below and we will get back to you. We’ll be glad to help. [ninja_form id=1]
Further Reading from Acorn Regulatorymore than 5600 orphan designated drugs in the biopharmaceutical pipeline. As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability. We look at some facts about orphan designation that companies considering entering the sector should be aware of. Read more about orphan drugs here. Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended). Read more about medicinal product labelling here.
- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely