eCTD Baseline Submissions

In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.

Editor’s Note:  This article was first written in September 2017.  We have continued to track changes and developments in the electronic publishing and eCTD sector.  You can stay up to date with everything that we are writing on the eCTD issue by clicking here.

You can read more about our eCTD and electronic publishing services by clicking here.

January 2018 Deadline

From Jan 2018 MHRA will only accept eCTD for all submissions. MHRA are anticipating that eCTD will be mandatory for all submissions after eCTD becomes mandatory for all procedures as outlined by the EU roadmap (Jan 2018)

According to the general guidance from the European Medicines Agency (EMA) and the Heads of Medicines Agency it is highly recommended but not mandatory to use a baseline as a start of an eCTD when changing from paper or NeeS and to provide as much content as possible in the eCTD.

MHRA however has communicated that baselines are compulsory.

Is it 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. Acorn Regulatory can support you with this plan and will take care of converting your dossier to eCTD by using a baseline submission application in eCTD.

We Can Help

We have the technical knowledge and expertise and software in house to ensure the smooth transfer of your dossiers before the deadline January 2018 which is quickly approaching.  Get in touch with us today about your eCTD needs in advance of the deadline. Complete the form below and we will get back to you.

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