Pharmaceutical Submissions: eCTD, RPS or Cloud vs. Paper Shipments

Canada is lagging behind the US, Europe, and Japan in accepting electronic submissions for pharmaceutical companies. To help promote electronic submissions, Adlib has been participating in events sponsored by Lorenz Life Sciences Group and Regxia to help Canadian regulatory professionals understand and leverage the eCTD. The latest event was held on November 18 in Vancouver, British Columbia.

Wolfgang Witzel (right), President of Lorenz, gave an interesting talk that included a brief history of the progress to date from paper to electronic submissions. His presentation included a picture of a paper submission ready to ship along with him holding the electronic equivalent. The paper submission copies were on shipping pallettes and weighed in at more than two tones.

Witzel also speculated on the future of electronic submissions, and the benefits of moving the technology used to publish, review, and approve submissions into the cloud where collaboration between sponsors and agencies could be managed much more efficiently than the current method of shipping or transmitting gigbytes of information around the world.

The road is littered with attempts by different organizations and countries to establish a standard. Then a rare moment of multi-national cooperation resulted in the eCTD specification by the ICH ( International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). This standard is taking hold in the US, Japan, many European nations and Canada.

However, before we are even comfortable with this standard, a new and more comprehensive standard is in the works – Regulated Product Submission (RPS). RPS builds on the eCTD standard which is only applicable to drugs and biologics, resulting in a standard that can be used by all divisions of the FDA as a standard method of receiving documentation for regulatory activities such as product approval applications. It is also superior to the eCTD in that it permits two-way communication between the application sponsor and the agency.

The day included other interesting presentations from regulatory professionals discussing their experience in eCTD submissions and lessons learned along the way. Tracy Brown from Health Canada encouraged attendees to start submitting eCTDs. Health Canada is moving towards accepting electronic-only submissions and has recently increased the scope of submissions being accepted in eCTD format. The data in her presentation showed that Canada has a way to go, since eCTD electronic only submissions make up only 0.1% of electronic submissions to Health Canada while CTD paper and electronic co-submissions make up 84%.