What You Need To Know About Mandatory eCTD


Now that eCTD is mandatory, you need to ensure that your dossiers are in the eCTD format.  In this article we look at mandatory eCTD and what you need to do. The eCTD format is required for all new MAAs submitted under National Procedures by 1 July 2018 and for all regulatory activities affecting National Procedures from 1 January 2019. According to the annex   “regarding the eSubmission Roadmap, on average, approximately half of all National Procedures were submitted in eCTD format in EU, in some NCAs even 100%. Some NCAs have already announced their intentions to require eCTD format submissions for purely Nationally Authorised Products (NAPs) to achieve simplifications of processing and working with dossiers regardless of the procedure type and regulatory activity at any level.

It is therefore highly recommended that if there is no regulatory activity planned for these licences before 2018 the MHRA would advise that a plan is introduced now. We can support you with this plan and will take care of converting your dossiers to eCTD. Acorn Regulatory has the technical knowledge and expertise and software in house to ensure the smooth transfer of your dossiers to the eCTD format.

Acorn Regulatory can assist you with importing your dossiers into eCTD. Whether already in the eCTD format or not we can organise your dossiers according to ICH and EU specifications and import your dossiers into eCTD. Batch imports allow multiple submissions into eCTD or even multiple dossiers into eCTD. We will create and maintain a life cycle management of your dossiers and ensure the latest EU Module 1 is implemented. Whether it is for European submission or submissions to the US (FDA), we can assist with importing dossiers into eCTD and submit to the regulatory authorities both in the EU and to the FDA.

If you would like to talk to us about your eCTD requirements simply complete the form below or call us on 00353 52 61 76706.

Further eCTD Reading from Acorn Regulatory

Acorn Regulatory’s Essential Guide to eCTD & Electronic Publishing

We have worked with companies around the world on electronic publishing and eCTD issues for many years.  Acorn Regulatory has its own dedicated publishing team, led by Eileen Ryan, and they assist our clients on an ongoing or ad-hoc basis.  Here, we have compiled some of the most read articles written by our team.