The Head of Medicines Agencies (HMA) have updated the eSubmission roadmap

The major changes in the new version are:

  1. Timelines for eCTD 4.0 have been removed, while the mandatory use of eCTD and VNeeS continue to be valid
  2. Timelines for the stepwise delivery towards the mandatory, fully integrated, single submission portal and use of data-set
  3. The New Veterinary Regulation (NVR) has been included

 

At Iperion, one of our main drivers is to assist the pharmaceutical industry in the journey of transition towards a data-driven Industry.

One of the key components in this journey is the Regulatory Affairs information.

 

Iperion helps companies with aligning to the key principles of the Telematics vision.

  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

 

If you have any question about the challenges ahead and would like to receive further information, please contact us at info@iperion.com