1. International Council on Harmonisation (ICH)
1.3. Electronic versions of MA applications – e-submissions
A paper based MA application dossier is a logistical challenge. More than 200,000 pages per dossier takes up a lot of physical space in the assessment phase as well as an enormous amount of space in both local and remote archives. Recently a case has been reported where the full dossier comprised 18,000 000 (18 MILLION!) A4 pages. When the CTD was finalised, work progressed in developing a standard for an electronic version, an eCTD. This standard is a detailed guidance on how to combine all the individual electronic documents into a folder and file structure.
Today an application to the EMA for the centralised procedure can only be submitted as an eCTD. Paper applications are no longer accepted. The same is true for some member states (MS) when it comes to other application procedures. Documentation in paper is still accepted in a number of countries, particularly for national applications.
The most convenient way of submitting and receiving electronic applications is via an e-portal. The EMA has a portal for uploading applications under the centralised procedure. Many MS have developed similar portals. For national and mutual-recognition (MRP) or decentralised (DCP) applications, applicants would need to upload their e-submissions via a large number of different national portals. To avoid this, the National Competent Authorities (NCAs) of a large number of member states have developed a common portal. This is called the Common European Submission Platform (CESP).
Figure 2: Diagram highlighting the member states that participate in the Common European Submission Platform (CESP).
A majority of regulatory agencies, for both human and veterinary medicines, participate in the CESP project. The project is controlled via agreements in the HMA (Heads of Medicines Agencies).
Most of the other ICH partners outside Europe have only one medicines agency. This means that the logistic problems in creating portals for industry to upload e-submissions are far less, as each country requires only one portal to upload an eCTD.