What’s Happening with the eSubmission Roadmap?

The eSubmission roadmap is filled with significant dates that can impact on your business.  Here, we look at developments on the eSubmissions roadmap up to 2020.

Editor’s Note:  We first published this article in 2017.  Since then there have been many developments surrounding the electronic common technical document (eCTD).  In this updated article we map out the timeline associated with eSubmissions and update it with any changes that have occurred since 2017. 

eSubmission eCTD Timeline Acorn Regulatory

What Is The eSubmission Roadmap?

The final adopted version of the roadmap was published in February of 2017 and states that the eSubmission roadmap  “is a high level strategic plan for business and technology change, typically operating across multiple disciplines over several years. It is a tool to align the plans of target groups and help National Competent Authorities (NCAs), EMA and pharmaceutical industry to prepare themselves to forthcoming changes. It clarifies objectives and activities to reach them. It sets a common timeline for development. It helps supporting strategic decisions and resource provisions. It is thus an important communication tool which helps to find a common understanding and commitment. It is therefore addressed to decision makers at executive management level”.

The aim of the roadmap is to drive the adoption of eSubmissions and the elimination of paper based applications and physical media.  In doing so, the eSubmission Roadmap team hopes that there will be greater interoperability of applications between regulators and pharmaceutical companies.

The eSubmission vision is to create:

  1. Consistent, efficient, effective and secured electronic handling (creation, submission, reception, validation, processing and distribution) of information for all procedures throughout the life cycle of medicinal products.
  2. Fully electronic processing without paper or any physical media.
  3. Usage of structured data in submission processes which can be electronically processed and re-used by both authorities and industry.
  4. Identical information made available to all authorities and eventually to one single repository.
  5. Use and re-use of master data in eSubmissions where applicable.
  6. Harmonisation of different message formats leading to a minimum set of electronic message types for the exchange of information.
  7. One single entry point for submission of applications to all authorities.
  8. Harmonised and reduced requirements for provision of metadata used in eSubmissions.

To achieve the aims listed above will require pharmaceutical companies and regulators to move completely away from paper based applications and the production of physical media.  The January 1st 2018 deadline for the submission of all EU procedures in eCTD is just one of many deadlines that the industry will need to be aware of.

Below, we have laid out the  deadlines, by quarter, as they fall due/have fallen due.  You can read the entire eSubmissions Roadmap document here.

2018 – Q1

  • eCTD for all submissions in EU procedures.
  • Integration of Human and VET new MAA’s into CESSP.

2018 – Q2 (Vet)

Vet: Mandatory use of the Common Repository for transmission of all CP submissions to the National Competent Authorities (6 months after implementation).

2018 – Q3

  • eCTD only for New MAA’s submissions in National Procedures (Note: baseline submissions are not required).
  • VNeeS only for New MAA’s in National Procedures.
  • Mandatory use of CESSP* for new Human and Vet MAA (6 months after implementation).

2019 – Q1

  • eCTD only for all submissions in National Procedures (Note: baseline submissions are not required).
  • VNeeS only for all submissions in National Procedures.

2019 – Q3

  • Optional use of eCTD v4.0 in CP (timeline subject to change).
  • Step 4: Integration of variation and renewal application forms into CESSP.

2020 – Q1

  • Mandatory use of the integrated application form and submission for all submissions through CESSP.

2020 – Q3

  • Optional use of eCTD v4.0 in MRP and DCP (timeline subject to change)

We will continue to update this article if changes are introduced.  We recommend signing up to the Acorn Regulatory newsletter here to keep in touch with what is happening in the regulatory sector.

eCTD and issues associated with it can feel daunting for many companies.  We can assist you with your eCTD needs.  We employ a full time publishing team that can assist you with all aspects of electronic publishing.

Contact us today on 00353 52 61 76 706 or complete your details below and we will get back to you.

 

About the Author:
Sinead Smyth
Regulatory Affairs Advisor
Sinead Smyth is responsible for supporting the Regulatory Affairs Team in the submission publishing process for the preparation of regulatory documentation in eCTD, NeeS or paper formats as required. Her works involves compiling, formatting and publishing regulatory activities to ensure a high quality, compliant, valid and timely submission to the health authorities. You can read other articles by Sinead Smyth by clicking the link below.
Other articles by Sinead Smyth