DCP Applications To Be Accepted Only in eCTD format from July 1st 2015

Looking back on how far we have progressed from the standard paper submission one thing is clear –  the age of  the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st July 2015 new MAAs for DCP applications will be accepted only in eCTD format in the EU.   Furthermore, all EU procedures will be moved to eCTD only by Q1 2018.[http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html]

These timelines are no longer a futuristic date, but a realisation that submissions are moving to eCTD (Electronic Common Technical Document) whether companies are prepared for the change or not.

So how can we help with your Electronic Submissions?

Acorn Regulatory provide a number of services  in order to help companies meet these pressing deadlines.  For instance, Acorn Regulatory provide customised training sessions  ensuring in-house personnel are equipped with the knowledge to transition to eCTD or NeeS smoothly.  Or, why not outsource all or part of your publishing needs?   This can mean for example that the regulatory creation of the documents can remain in-house & the publishing function (i.e creation, formatting, building or submitting of the eCTD/NeeS submission) could be outsourced to Acorn Regulatory as necessary.

Perhaps, in an effort to move to electronic format you may have a number of longstanding dossiers that have not yet been transferred fully to NeeS or eCTD?  Rest assured that Acorn Regulatory can review, perform a gap analysis and convert your dossiers to electronic format successfully to fit your every requirement.

Whatever your electronic submissions needs may be, why not give us a call to see how Acorn Regulatory can help you achieve them?

The countdown is on.

If you would like to speak to us about this issue, please feel free to call us on 00353 52 61 76 706 or complete your details below.

 

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD