The electronic Submission (eSubmission) roadmap has introduced very strict milestones for the mandatory use of eCTD format. Are you aware of the deadlines that have passed or the deadlines that are approaching?
So, What does the eSubmission roadmap entail?
The eSubmission roadmap aims at establishing secure, consistent and efficient electronic submission processes for medicinal products for human and veterinary use across the European Medicines Regulatory Network.
It will lead to increased efficiency through sustainable fully end to end electronic processing of information, meaning elimination of paper to enable and facilitate electronic collaborative processes and re-use of data as well as increased transparency and sharing of information within the Network throughout the medicinal product lifecycle. It is a tool to align the plans of target groups and help National Competent Authorities (NCAs) and pharmaceutical industry to prepare themselves to forthcoming changes.
What are the forthcoming eCTD changes?
Firstly, the use of eCTD for new MAA in DCP has been in place since 1 July 2015. This was then followed up with another eCTD deadline. Applications for marketing authorisation within the Decentralised Procedure (DCP) had to be be submitted in eCTD format from 1 January 2016.
Subsequently the use of eCTD for new MAA in MRP was introduced earlier this year on 1 January 2017. It is now mandatory for all new MAA applications in MRP to be submitted in the eCTD format.
2018 eCTD Deadline
The use of eCTD for all regulatory activities in European procedures (DCP/MRP) became mandatory on 1 January 2018. This refers to all submission types for a dossier such as variations, renewals, PSURs. The requirement is applicable for all submissions from that date whatever current format of the concerned dossier.
It is now imperative that each Marketing Authorisation holder has converted their dossier and agreed with their National Competent Authority the regulatory strategy for submission of the baseline sequence. While, it may seem that companies are ready there are some that still have not carried out any work on their paper based dossiers. Don’t worry – we can help.
Contact Acorn Regulatory for further advice and assistance with converting your dossier to the eCTD format on 052 6176706. We employ publishing specialists who can handle your eCTD issues efficiently. Contact us on the number above or complete your details below and we will get back to you.
Further eCTD Reading from Acorn Regulatory
Acorn Regulatory’s Essential Guide to eCTD & Electronic Publishing