Heath Canada intends to begin piloting the use of its Regulatory Enrollment Process through the Common Electronic Submission Gateway for medical device applications by this summer.
The REP — currently being tested by sponsors of pharmaceuticals and biologics to electronically send applications — was designed to “reengineer existing administrative processes to take advantage of the tools and capabilities of an electronic processing and review environment,” Health Canada said.
The goal is for the collection of web-based templates, which capture metadata in an XML format, to provide for consistency across different types of regulatory activities.
For sponsors, potential benefits include reducing the time spent on submissions and the associated costs. This is because the CESG allows Health Canada to “partially populate internal systems ahead of time and automate certain procedures when a submission is received” in an electronic common technical document (e-CTD) format, the agency said.
Health Canada began accepting regulatory submissions in the standardized e-CTD format in 2004. It stopped accepting paper copies of the submissions as of last April, after which non-eCTD electronic-only formats became the only ones accepted for Class III and IV medical devices. The pilot seeks to expand the scope of non-eCTD formats that the CESG can accept. — Ana Mulero