For some years now, electronic submission gateways and how to use them have been a hot topic of discussion in the Regulatory Affairs world. Following the move from paper to electronic submission formats, gateways can be considered the next step in an evolution. As Beate Kienzler put it during her presentation at the LORENZ userBridge.14 conference in Milan, “we are moving from low parcel content to no parcel content”.
With this expression, Beate was referring to the many past and ongoing changes in the Regulatory Affairs sector– changes that focus primarily on delivery processes. Not so long ago, people actually stamped page numbers onto paper by hand, and had to cart around tons of paper – literally – in order to get a submission to the agency. On the agency side, an equivalent effort was needed to process these unwieldy applications.
With electronic submissions, the pure logistics side of the process was improved and sped up enormously. Still, people needed to burn CD-ROMs/DVDs, put them into a package and actually deliver it. Now, with electronic submission gateways, even this step can be eliminated.
Listening to Beate’s views on the benefits and challenges of working with gateways in their current form, I could follow her arguments quite clearly. While she sees the benefits of gateways, she also points out that currently there are “a lot of parallel activities” going on. You have to follow up on these multiple activities very closely “to stay up to date and to have the current information”. In addition to all of the changing regulatory requirements that put new requirements on the actual content of the submissions, in parallel one must now also keep up with all of their new delivery requirements.
Beate provided a lot of good links to information when working with these gateways that can serve as a check and reference list. I recommend to bookmark them:
Requirements for gateways can be found here:
- CESP information on country specific usage => http://cesp.hma.eu/Contacts
- HMA requirements on eSubmissions => http://www.hma.eu/277.html
- EMA eSubmission information => http://esubmission.ema.europa.eu/
- EMA Dossier information => http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003980.pdf
- Eudralex Volume 2 http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm
Before you send to a gateway, please review this list for common errors, when…
…working with CESP
- Wrong file first sent (first zip – second XML)
- XML file and zip-file are not related to each other
- Duration of upload
- Zip-file format
…working with EMA eSubmission Gateway
- File name
- Duplicate submissions
- Incorrect folder structure / root of zip-file
- Password protection
- Additional submission of CD/DVD/CESP (EMA + Common Rep Country)
In summary, one could say that today…
- Gateways improve the speed of delivery
by removing waste from the process (e.g. processing of CD/DVDs)
- Gateways are effective, but not yet fully efficient
They do the job, however, there is duplication of information in delivery files, application forms and processes and required workflows that must be done manually.
- Gateways are still perceived as “technical”
The handling of certificates and technical protocols requires too much IT know-how.
- Gateways are not yet harmonized
There is a profusion of portals and gateways, requiring different technologies and workflows.
Many of these concerns can be addressed already today by implementing “most desirable solutions”, which point to an easy to use interface. Looking at the pros and cons of the discussion, I definitely agree with Beate’s summary that “to stay with paper is not a solution”. I personally would add that gateways are here to stay and will become more user-friendly over time. They will further improve process, speed and quality of the regulatory “delivery” process.