Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry. With a goal to spread digitalization across each and every aspect of market authorization of medicinal products, national drug regulatory authorities across the Europe along with the European Medicines Agency (EMA) have recently updated a document titled “eSubmission Roadmap”.

What is eSubmission Roadmap?

eSubmission Roadmap is a document which talks about general format and submission requirements of medicinal products’ applications that are directed towards the Danish Health and Medicines Authority (DHMA) and the other European Drug Regulatory authorities. Intended to present long term objectives of the authorities and the way they should be implemented; the document concerns submissions from the industry to the health authorities with respect to medicinal products’ applications such as:

  • marketing authorizations
  • variations
  • update prior to MRP
  • renewal
  • follow-up
  • referral to CMD and PSUR
  • human and veterinary applications

The document also applicable to Active Substance Master Files (ASMFs). The document applies to human and veterinary applications under:

  • the centralised procedure (CP)
  • the decentralised procedure (DCP) and
  • the mutual recognition procedure (MRP)

However, requirements for applications under the national (NP) are yet to be determined by the national authorities and are expected to be aligned with the requirements for submissions under the mutual recognition procedure (MRP).

As discussed earlier, the document discusses some long-term objectives rooted from eSubmission Roadmap, which can be listed as:

  • eliminating paper application submissions
  • establishing electronic application forms (eAF)
  • eliminating the use of physical media such as CD
  • mandatory eCTD format for applications for medicinal products for human use
  • mandatory VNeeS format applications for medicinal products for veterinary use
  • central / single EU eSubmission portal for submissions to all authorities irrespective of the procedures
  • implementing common repository for applicants’ submissions

Towards achieving the long term objectives, the document also discusses some of the milestones set forth by the European regulatory authorities. That includes mandatory eCTD and VNeeS information. With the health authorities setting platform for electronic submissions, the obvious move for organizations willing to submit medicinal products’ applications in the region should be choosing an expert Regulatory partner specialized in eCTD conversions. With successful 30,000+ eCTD submissions, Freyr stands your preferred publishing and submissions partner. Let us know your unique requirements.


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